Amantadine Hydrochloride (Page 5 of 5)

HOW SUPPLIED

NDC:17856-0093-3 in a CUP, UNIT-DOSE of 5 SOLUTIONS

Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature].

KEEP TIGHTLY CLOSED

Dispense in a tight container as defined in the USP, with a child-resistant closure (as required).

Rx Only

REFERENCES

W.W. Wilson and A.H. Rajput, Amantadine-Dyazide Interaction, Can. Med. Assoc. J. 129:974–975, 1983. 1

D.F. Casey, N. Engl. J. Med. 298:516, 1978. 2

C.D. Berkowitz, J. Pediatr. 95:144, 1979. 3

Product No.: 8093

Manufactured for: Wockhardt USA, LLC Parsippany, NJ 07054

Manufactured By: Morton Grove Pharmaceuticals, Inc. Morton Grove, IL 60053

A50-8093-16

REV. 09-11

DISTRIBUTED BY:

ATLANTIC BIOLOGICALS CORP.

MIAMI, FL 33179

AMANTADINE HYDROCHLORIDE SOLUTION

image 1
(click image for full-size original)

image 2
(click image for full-size original)
AMANTADINE HYDROCHLORIDE
amantadine hydrochloride solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:17856-0093(NDC:60432-093)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Amantadine Hydrochloride (Amantadine) Amantadine Hydrochloride 50 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
Water
Sorbitol
Propylene Glycol
Trisodium Citrate Dihydrate
SACCHARIN SODIUM
Methylparaben
Propylparaben
Anhydrous Citric Acid
Product Characteristics
Color Score
Shape Size
Flavor RASPBERRY Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:17856-0093-3 5 mL in 1 CUP, UNIT-DOSE None
2 NDC:17856-0093-1 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE contains a CUP, UNIT-DOSE
2 10 mL in 1 CUP, UNIT-DOSE This package is contained within the BOX, UNIT-DOSE (17856-0093-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075060 12/24/1998
Labeler — Atlantic Biologicals Corps (047437707)
Registrant — Atlantic Biologicals Corps (047437707)
Establishment
Name Address ID/FEI Operations
Atlantic Biologicals Corps 047437707 RELABEL (17856-0093), REPACK (17856-0093)

Revised: 05/2020 Atlantic Biologicals Corps

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2020. All Rights Reserved.