LONHALA MAGNAIR (Page 4 of 4)

16. HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

LONHALA MAGNAIR is supplied as a 1 mL sterile, clear, colorless, aqueous solution in low-density polyethylene (LDPE) unit-dose vials overwrapped in foil. LONHALA MAGNAIR is available in a Starter Kit containing 60 unit-dose vials packaged with one MAGNAIR, and FDA approved patient labeling. LONHALA MAGNAIR is also supplied in a Refill Kit containing 60 unit-dose vials packaged with a MAGNAIR Replacement Handset and FDA approved patient labeling.

Package Configuration Dosage Strength NDC
Starter Kit with 30 day supply (30 foil pouches with 2 vials per pouch) and complete MAGNAIR Nebulizer System 25 mcg NDC: 63402-201-00
Refill Kit with 30 day supply (30 foil pouches with 2 vials per pouch) and MAGNAIR Replacement Handset 25 mcg NDC: 63402-301-01

16.2 Storage and Handling

Store LONHALA Inhalation Solution in the protective foil pouch at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].

  • LONHALA vials should be used with MAGNAIR only. Do not use MAGNAIR with any other vials.
  • Store LONHALA vials in the protective foil pouch. After opening the foil pouch, unused unit-dose vials should be returned to, and stored in, the foil pouch. Once a foil pouch is opened, discard the vials if not used within 7 days. An opened unit-dose vial should be used right away. Discard any unit-dose vial if the solution is not colorless.

Always use the MAGNAIR Replacement Handset parts that come with each LONHALA MAGNAIR refill prescription.

Keep out of the reach of children.

17. PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).

Not for Acute Symptoms: Inform patients that LONHALA MAGNAIR is not meant to relieve acute symptoms of COPD and extra doses should not be used for that purpose. Advise them to treat acute symptoms with a rescue inhaler such as albuterol. Provide patients with such medicine and instruct them in how it should be used [see Warnings and Precautions (5.1)].

Instruct patients to seek medical attention immediately if they experience any of the following:

  • Symptoms get worse
  • Need for more inhalations than usual of their rescue inhaler

Patients should not stop therapy with LONHALA MAGNAIR without physician/provider guidance since symptoms may recur after discontinuation.

Paradoxical Bronchospasm: Inform patients that LONHALA MAGNAIR can cause paradoxical bronchospasm. If paradoxical bronchospasm occurs, instruct patients to discontinue LONHALA MAGNAIR.

Worsening of Narrow-Angle Glaucoma: Instruct patients to be alert for signs and symptoms of acute narrow-angle glaucoma (e.g., eye pain or discomfort, blurred vision, visual halos or colored images in association with red eyes from conjunctival congestion and corneal edema). Instruct patients to consult a physician immediately if any of these signs or symptoms develop.

Worsening of Urinary Retention: Instruct patients to be alert for signs and symptoms of urinary retention (e.g., difficulty passing urine, painful urination). Instruct patients to consult a physician immediately if any of these signs or symptoms develop.

Instructions for Administering LONHALA MAGNAIR

It is important for patients to understand how to correctly administer LONHALA vials using MAGNAIR [see Instructions for Use]. Instruct patients that LONHALA vials should only be administered via MAGNAIR and MAGNAIR should not be used for administering other medications. Patients should be instructed not to inject or swallow the LONHALA solution.

Instruct patients to store LONHALA vials in the sealed foil pouch and to only open the foil pouch to remove a LONHALA vial immediately before use. Inform patients that unopened vials should be returned to the opened foil pouch for use at their next treatment and discarded if not used within 7 days or it may not be as effective.

Inform patients to use one inhalation of LONHALA MAGNAIR orally twice daily (1 vial in the morning and 1 vial in the evening) at the same time every day.

Inform patients that if they miss a dose of LONHALA MAGNAIR, they should use their next vial at the usual time. Instruct patients to not use 2 vials at one time and to not use more than 2 vials in a day. Patients should throw the plastic dispensing vials away immediately after use. Due to their small size, the vials pose a danger of choking to young children.

Inform patients treated with LONHALA MAGNAIR that a Refill Kit will be provided to them on a monthly basis. The Refill Kit will include foil pouches containing 60 vials of LONHALA (2 vials of LONHALA in each pouch; 1 vial per dose), and 1 MAGNAIR Replacement Handset (containing only these replacement parts: Medication cap, Handset body, Mouthpiece, and Aerosol head; Manufacturer’s Instructions for Use booklet).

Important: Instruct patients to throw away the old Handset parts after using 60 vials of LONHALA and use the replacement Handset parts with the next 60 vials of LONHALA.

Sunovion Logo

Manufactured for Sunovion Respiratory Development Inc.,
a direct wholly-owned subsidiary of Sunovion Pharmaceuticals Inc.
84 Waterford Drive
Marlborough, MA 01752 USA

For Sunovion customer service, call 1-888-394-7377.
For medical information, call 1-800-739-0565.To report suspected adverse events, call 1-877-737-7226.

©2020 Sunovion Pharmaceuticals Inc. All rights reserved.

PATIENT INFORMATION LONHALA MAGNAIR (lon-HAH-luh MAGG-nair) (glycopyrrolate) inhalation solution, for oral inhalation use
Important: For oral inhalation only. Do not inject or swallow the LONHALA medicine. LONHALA vials are used only with the MAGNAIR device. Do not use MAGNAIR with any other medicine.
Read this Patient Information that comes with LONHALA MAGNAIR before you start using it and each time you get a refill. There may be new information. This Patient Information does not take the place of talking to your healthcare provider about your medical condition or treatment.
What is LONHALA MAGNAIR? LONHALA MAGNAIR is an anticholinergic medicine known as glycopyrrolate.
  • Anticholinergic medicines such as LONHALA MAGNAIR help the muscles around the airways in your lungs stay relaxed to prevent symptoms such as wheezing, coughing, chest tightness, and shortness of breath. This makes it hard to breathe.
  • LONHALA MAGNAIR is used for maintenance treatment of Chronic Obstructive Pulmonary Disease (COPD). COPD is a long-term (chronic) lung disease that includes chronic bronchitis, emphysema, or both.
  • LONHALA MAGNAIR is for long-term use and should be taken 2 times each day to improve symptoms of COPD for better breathing.
  • LONHALA MAGNAIR is not used to treat sudden symptoms of COPD. Always have a short-acting beta2 -agonist medicine (rescue inhaler) with you to treat sudden symptoms of COPD. If you do not have a rescue inhaler, contact your healthcare provider to have one prescribed for you.
  • LONHALA MAGNAIR should not be used in children. It is not known if LONHALA MAGNAIR is safe and effective in children younger than 18 years of age.
Do not use LONHALA MAGNAIR if you:
  • are allergic to glycopyrrolate, or any of the ingredients in LONHALA MAGNAIR. Ask your healthcare provider if you are not sure. See “What are the ingredients in LONHALA MAGNAIR? at the end of this Patient Information leaflet for a complete list of ingredients in LONHALA MAGNAIR.
Before using LONHALA MAGNAIR, tell your healthcare provider about all of your medical conditions, including if you:
  • have kidney problems.
  • have eye problems such as glaucoma. LONHALA MAGNAIR may make your glaucoma worse.
  • have prostate or bladder problems, or problems passing urine. LONHALA MAGNAIR may make these problems worse.
  • are pregnant or plan to become pregnant. It is not known if LONHALA MAGNAIR can harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if the medicine in LONHALA MAGNAIR passes into your breast milk and if it can harm your baby. You and your healthcare provider should decide if you will take LONHALA MAGNAIR or breastfeed.
  • are allergic to LONHALA MAGNAIR or any of its ingredients or any other medicines.
Tell your healthcare provider about all the medicines you take, including prescription medicines and over-the-counter medicines, vitamins, and herbal supplements. LONHALA MAGNAIR may affect the way other medicines work, and other medicines can affect how LONHALA MAGNAIR works. Using LONHALA MAGNAIR with other medicines may cause serious side effects.Especially tell your healthcare provider if you take anticholinergics (including umeclidinium, tiotropium, ipratropium, aclidinium, glycopyrrolate). Know the medicines you take. Keep a list of your medicines with you and show it to your healthcare provider and pharmacist when you get a new medicine.
How should I use LONHALA MAGNAIR? Read the step-by-step instructions for using LONHALA MAGNAIR at the end of this Patient Information leaflet and the Manufacturer’s Instructions for Use booklet. The Manufacturer’s Instructions for Use booklet provides complete information about how to put together (assemble), prepare, use, care for, and trouble-shoot your MAGNAIR nebulizer system.
  • Do not use LONHALA MAGNAIR unless your healthcare provider has taught you how to use the device and you understand how to use it correctly.
  • Use LONHALA MAGNAIR exactly as your healthcare provider tells you to use it. Do not use LONHALA MAGNAIR more often than prescribed for you.
  • Only use LONHALA vials with the MAGNAIR device.
  • Do not inject or swallow the LONHALA medicine.
  • Inhale the medicine in 1 LONHALA vial through the MAGNAIR device 2 times each day (1 vial in the morning and 1 vial in the evening) at the same time each day.
  • If you miss a dose of LONHALA MAGNAIR, take your next dose at your usual time.
    • Do not use 2 vials at 1 time.
    • Do not use more than 2 vials in a day.
  • Do not stop using LONHALA MAGNAIR or other medicines to control or treat your COPD unless told to do so by your healthcare provider because your symptoms might get worse. Your healthcare provider will change your medicines as needed.
  • Call your healthcare provider or get emergency medical care right away if your breathing problems worsen with LONHALA MAGNAIR, you need to use your rescue medicine more often than usual, or your rescue inhaler medicine does not work as well for you at relieving your symptoms.
What are the possible side effects of LONHALA MAGNAIR? LONHALA MAGNAIR can cause serious side effects, including:
  • sudden shortness of breath immediately after use of LONHALA MAGNAIR. Sudden shortness of breath may be life-threatening. If you have sudden breathing problems immediately after inhaling your medicine, stop taking LONHALA MAGNAIR and call your healthcare provider or go to the nearest hospital emergency room right away.
  • serious allergic reactions. Stop using LONHALA MAGNAIR and call your healthcare provider or get emergency medical care right away if you get any of the following symptoms of a serious allergic reaction:
  • rash
  • swelling of the tongue, lips, and face
  • hives
  • difficulty breathing or swallowing
  • new or worsened eye problems including acute narrow-angle glaucoma. Acute narrow-angle glaucoma can cause permanent loss of vision if not treated. Symptoms of acute narrow-angle glaucoma may include:
  • eye pain or discomfort
  • blurred vision
  • nausea or vomiting
  • red eyes
  • seeing halos or bright colors around lights
If you have any of these symptoms, stop taking LONHALA MAGNAIR and call your healthcare provider right away before using another dose.
  • new or worsened problems emptying your bladder (urinary retention). People who use LONHALA MAGNAIR may develop new or worsened urinary retention. Urinary retention can be caused by a blockage in your bladder. Urinary retention can also happen in men who have a larger than normal prostate. Symptoms of urinary retention may include:
  • difficulty urinating
  • painful urination
  • urinating frequently
  • urination in a weak stream or drips
If you have any of these symptoms, stop taking LONHALA MAGNAIR and call your healthcare provider right away before taking another dose.Common side effects of LONHALA MAGNAIR include shortness of breath, and urinary tract infections. These are not all of the possible side effects of LONHALA MAGNAIR.Call your doctor or pharmacist for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store LONHALA MAGNAIR?
  • Store LONHALA vials in the protective foil pouch at room temperature between 68°F and 77°F (20°C and 25°C).
  • LONHALA vials should be used with the MAGNAIR device only. Do not use MAGNAIR with any other medicine.
After opening the protective foil pouch, unused LONHALA vials should be returned to, and stored in, the opened foil pouch. Once a foil pouch is opened, discard the vials if not used within 7 days.
  • An opened LONHALA vial should be used right away.
  • Throw away the LONHALA vial right away after use.
  • The medicine in the LONHALA vial should be colorless. Throw away the LONHALA vial if the medicine is not colorless.
  • Always use the MAGNAIR Replacement Handset parts that come with each LONHALA MAGNAIR refill prescription.
  • Keep LONHALA MAGNAIR and all medicines out of the reach of children.
General information about the safe and effective use of LONHALA MAGNAIR. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use LONHALA MAGNAIR for a condition for which it was not prescribed. Do not give LONHALA MAGNAIR to other people, even if they have the same symptoms you have. It may harm them.You can ask your healthcare provider or pharmacist for information about LONHALA MAGNAIR that is written for healthcare professionals.

What are the ingredients in LONHALA MAGNAIR?

Active ingredient: glycopyrrolateInactive ingredients: citric acid monohydrate, sodium chloride, sodium hydroxide and water for injection.

Sunovion Logo
Manufactured for:Sunovion Respiratory Development Inc., a wholly-owned subsidiary of Sunovion Pharmaceuticals Inc.Marlborough, MA 01752 ©2020 Sunovion Pharmaceuticals Inc. All rights reserved.For more information, go to www.LonhalaMagnair.com or call Sunovion Customer Service at 1-888-394-7377.This Patient information has been approved by the U.S. Food and Drug Administration Revised: August 2020

INSTRUCTIONS FOR USE LONHALA MAGNAIR (lon-HAH-luh MAGG-nair) (glycopyrrolate) inhalation solution, for oral inhalation use
Read this Instructions for Use leaflet and the Manufacturer’s Instructions for Use booklet before you start using LONHALA MAGNAIR and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment. If you have any questions, ask your healthcare provider or pharmacist. The Manufacturer’s Instructions for Use booklet provides complete information about how to put together (assemble), prepare, use, care for, and troubleshoot your MAGNAIR nebulizer system.
Your LONHALA MAGNAIR:
MAGNAIR is a nebulizer system to be used by the patient, caregiver, or healthcare provider to deliver the medicine LONHALA. LONHALA MAGNAIR consists of both the MAGNAIR nebulizer system and the medicine LONHALA.The following supplies come with your LONHALA MAGNAIR:Starter Kit: Foil pouches containing 60 vials of LONHALA (2 vials of LONHALA in each pouch; 1 vial per dose), Instructional video, and 1 MAGNAIR Nebulizer System with carrying bag (including Manufacturer’s Instructions for Use booklet and Quick Reference Guide) (see the figure below).Refill Kit: Foil pouches containing 60 vials of LONHALA (2 vials of LONHALA in each pouch; 1 vial per dose), and 1 MAGNAIR refill Handset (containing only these replacement parts: Medication cap, Handset body, Mouthpiece, and Aerosol head; Manufacturer’s Instructions for Use booklet).Important: Throw away the old Handset parts after using 60 vials of LONHALA and use the replacement Handset parts in the Refill Kit with the next 60 vials of LONHALA.
Figure
Important: Check to make sure that your MAGNAIR nebulizer system is working properly before you use LONHALA MAGNAIR for the first time. See the Manufacturer’s Instructions for Use that come with your MAGNAIR nebulizer system.
Steps for Using Batteries with MAGNAIR
Figure
Figure
Figure
Step 1: Open the battery door on the Controller. Place your thumb on the black tab of the battery door and firmly push the tab to open the door. Step 2: Put 4 AA batteries in the Controller as shown. Step 3: Close the battery door.You may hear a “Click”.Important: Make sure to have an extra set of batteries with you at all times if you choose not to use the AC adapter.
Steps for Using the AC Adapter with MAGNAIR
Figure
(click image for full-size original)
Step 1: Plug the AC adapter into the Inlet on the battery door of the Controller.Step 2: Plug the AC adapter into the wall outlet.
Assembling Your MAGNAIR
Figure
Figure
Figure
Step 1: Wash your hands.Step 2: Open the top of the Handset body by lifting the clasp. Step 3: Insert the Aerosol head into the Handset body as shown.Do not touch the center of the Aerosol head. Notice that the Aerosol head has a small tab on the side. Align the small tab with the matching notch in the Handset body. Step 4: Close the Handset body. You may hear a “Click”.
Figure
Figure
Figure
Step 5: Attach the Mouthpiece to the Handset body. Make sure the Blue valve is pressed down. Step 6: Connect the Controller to the Handset body using the Connection cord. You may hear a “Click”. Step 7: Connect the Controller to the Handset body using the Connection cord as shown.
Using LONHALA MAGNAIR
Figure
(click image for full-size original)
Figure
Step 1: Open the foil pouch,enough to remove the 2 LONHALA vials and separate them. Return 1 vial to the opened foil pouch and store in the carrying bag to be used at the next treatment. Discard the vial if not used within 7 days. Step 2: Insert one LONHALA vial into the bottom of the Medication cap until it ”Clicks”.
Figure
Figure
Figure
(click image for full-size original)
Important: Do not touch the part of the Handset body that pierces the vial. Step 3: Make sure the Aerosol head is installed before attaching the Medication cap because your medicine could leak and you will not get your full treatment.Place the Medication cap with LONHALA vial on the top of the Handset body. Step 4: To attach the Medication cap to the Handset body, turn the Medication cap in a clockwise direction as shown, until you hear a “Click”. The notch in the Medication cap (at the base of the opening) should line up with the blue line on the Handset body.
Figure
Figure
Figure
(click image for full-size original)
Step 5: Insert the Mouthpiece into your mouth.Important: Do not tilt the Handset, loosen or remove the Medication cap, or unclasp the Handset body until the treatment is complete because you will not get your full treatment. Step 6: Press the On/Off button to turn on the Controller as shown, and start your treatment. Step 7: Breathe in (inhale) and breathe out (exhale) normally through the Mouthpiece.
Figure
At the end of your treatment, you will hear a beeping sound and the Controller will automatically shut off. Your treatment should take about 2 to 3 minutes.
Cleaning the Handset
Figure
Figure
Figure
Step 1: Disconnect the Handset from the Connection cord. Step 2: Turn the Medication cap in a counterclockwise direction as shown, to remove it from the Handset body. Step 3: Place the top of the Medication cap into the palm of your hand and push up as shown to remove the LONHALA vial. Throw away the LONHALA vial into the wastebasket.
Figure
Figure
Figure
Step 4: Remove the Mouthpiece from the Handset body by giving it a gentle twist and pull to separate from the Handset body. Step 5: Carefully loosen the Blue valve from the slot in the Mouthpiece. Make sure the valve is still attached on one side to the Mouthpiece. Step 6: Remove the Aerosol head from the Handset body by lifting the clasp on the side of the Handset body as shown.Do not touch the center of the Aerosol head.
Figure
Figure
Figure
Step 7: Set aside the Aerosol head to be cleaned separately (see Step 10). Rinse all Handset parts well with warm running water for about 10 seconds. Step 8: Wash all Handset parts in warm soapy water (water and clear liquid dishwashing soap) for about 10 seconds. Step 9: Rinse the Handset parts well with warm running water for about 10 seconds to remove all of the soap.
Figure
Figure
Figure
Step 10: Clean the Aerosol head using the instructions in Steps 7 through 10.10A. Rinse each side of the Aerosol head well with warm running water for about 10 seconds. 10B. Hold the Aerosol head by the handle and swish it back and forth in the warm soapy water for about 10 seconds.10C. Then, rinse both sides of the Aerosol head well with warm running water for about 10 seconds on each side.Rinsing the Aerosol head well helps prevent clogging and ensure proper operation. Step 11: Inspect all Handset parts to make sure they are completely clean. If any Handset parts are still dirty, soak the parts in warm soapy water for 5 more minutes. Rinse well with warm running water until the Handset parts are clean.Shake Handset parts to remove excess water. Air-dry all Handset parts on a lint-free towel.Do not put the Handset parts back together until ready to use again for your next treatment of LONHALA. Step 12: Store the Handset parts in the carrying bag provided.
Warnings and Precautions: Failure to follow the Warnings and Precautions below could cause serious injury or may lead to death in some cases:
  • Check all parts of your LONHALA MAGNAIR to make sure that they are clean and not damaged.
  • Clean the Handset before the first use and after every use. If you do not clean the Handset after every use, your treatment could take more than 3 minutes.
  • Do not leave the Aerosol head in your Handset.
  • Do not wash the Controller, Connection cord, or AC adapter.
  • Only use clear liquid dishwashing soap to wash the Handset parts. Do not use any other type of soap.
    • Do not use antibacterial soap. Antibacterial soap can damage the Aerosol head.
  • Do not use a microwave oven to dry any parts of your LONHALA MAGNAIR.
  • Allow all parts of your LONHALA MAGNAIR to air dry completely.

If you have any questions, contact Sunovion Customer Service at 1-888-394-7377.This Instructions for Use has been approved by the U.S. Food and Drug Administration.LONHALA and Figure
are registered trademarks of Sunovion Pharmaceuticals Inc. MAGNAIR is a registered trademark of PARI Pharma GmbH, used under license.SUNOVION and Figure
are registered trademarks of Sumitomo Dainippon Pharma Co., Ltd. Sunovion Pharmaceuticals Inc. is a U.S. subsidiary of Sumitomo Dainippon Pharma Co., Ltd.PARI and Figure
are registered trademarks of PARI GmbH.eFlow is a registered trademark of PARI Pharma GmbH. Made under license of The Technology Partnership plc.

Sunovion Logo

Manufactured for:Sunovion Respiratory Development Inc.,a wholly-owned subsidiary of Sunovion Pharmaceuticals Inc.Marlborough, MA 01752 ©2020 Sunovion Pharmaceuticals Inc. All rights reserved.Revised: August 202010140-03

PRINCIPAL DISPLAY PANEL – Starter Kit

NDC 63402-201-00

Lonhala™Magnair™
(glycopyrrolate) Inhalation Solution
25mcg/1mLStarter Kit

Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].

PRINCIPAL DISPLAY PANEL – Starter Kit
(click image for full-size original)

PRINCIPAL DISPLAY PANEL – Refill Kit

NDC 63402-301-01

Lonhala™Magnair™
(glycopyrrolate) Inhalation Solution
25mcg/1mLRefill Kit

Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].

PRINCIPAL DISPLAY PANEL – Refill Kit
(click image for full-size original)

PRINCIPAL DISPLAY PANEL – Product Carton — 60 vial carton

NDC 63402-101-30

Lonhala™
(glycopyrrolate) Inhalation Solution

25 mcg/1 mL

For Oral Inhalation OnlyWith Magnair™ Nebulizer System

Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].

Rx Only

Sunovion

PRINCIPAL DISPLAY PANEL – Product Carton -- 60 vial carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL – Product Foil Pouch — 2 vial pouch

NDC 63402-101-02

Lonhala™
(glycopyrrolate) Inhalation Solution

Two 1 mL Sterile Unit-Dose Vials

25 mcg/1 mL

For Oral Inhalation OnlyWith Magnair™ Nebulizer System

Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].

Rx Only

Sunovion

PRINCIPAL DISPLAY PANEL – Product Foil Pouch -- 2 vial pouch
(click image for full-size original)
LONHALA MAGNAIR glycopyrrolate solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63402-201
Route of Administration RESPIRATORY (INHALATION) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
glycopyrrolate (glycopyrronium) glycopyrrolate 25 ug in 1 mL
Inactive Ingredients
Ingredient Name Strength
Citric Acid Monohydrate
Sodium Chloride
Sodium Hydroxide
Hydrochloric Acid
Water
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63402-201-00 1 CARTON in 1 KIT contains a CARTON
1 30 POUCH in 1 CARTON This package is contained within the KIT (63402-201-00) and contains a POUCH
1 2 VIAL, SINGLE-DOSE in 1 POUCH This package is contained within the CARTON and contains a VIAL, SINGLE-DOSE
1 1 mL in 1 VIAL, SINGLE-DOSE This package is contained within a POUCH and a CARTON and a KIT (63402-201-00)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA208437 01/29/2018
LONHALA MAGNAIR glycopyrrolate solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63402-301
Route of Administration RESPIRATORY (INHALATION) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
glycopyrrolate (glycopyrronium) glycopyrrolate 25 ug in 1 mL
Inactive Ingredients
Ingredient Name Strength
Citric Acid Monohydrate
Sodium Chloride
Sodium Hydroxide
Hydrochloric Acid
Water
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63402-301-01 1 CARTON in 1 KIT contains a CARTON
1 30 POUCH in 1 CARTON This package is contained within the KIT (63402-301-01) and contains a POUCH
1 2 VIAL, SINGLE-DOSE in 1 POUCH This package is contained within the CARTON and contains a VIAL, SINGLE-DOSE
1 1 mL in 1 VIAL, SINGLE-DOSE This package is contained within a POUCH and a CARTON and a KIT (63402-301-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA208437 01/29/2018
Labeler — Sunovion Pharmaceuticals Inc. (131661746)

Revised: 12/2020 Sunovion Pharmaceuticals Inc.

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