Atovaquone (Page 5 of 5)

16 HOW SUPPLIED/STORAGE AND HANDLING

Atovaquone Oral Suspension, USP is a bright yellow, tutti frutti flavored, oral suspension containing 750 mg of atovaquone USP per 5 mL. It is supplied as follows:

NDC 16714-900-01 Bottle of 210 mL with child-resistant cap.

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Do not freeze.

17 PATIENT COUNSELING INFORMATION

Administration Instructions

Instruct patients to:

•

Ensure the prescribed dose of atovaquone oral suspension is taken as directed.

•

Take their daily doses of atovaquone oral suspension with food, as food will significantly improve the absorption of the drug.

•

Shake atovaquone oral suspension gently before use each time.

Lactation

•

Instruct mothers with HIV-1 infection not to breastfeed because HIV-1 can be passed to the baby in the breast milk [see Use in Specific Populations (8.2)].

Manufactured for:

Northstar Rx LLC

Memphis, TN 38141.

Manufactured by:
Glenmark Pharmaceuticals Limited

Village: Kishanpura, Baddi Nalagarh Road,

Dist. Solan, Himachal Pradesh -173205, India

September 2019

Package/Label Display Panel

NDC 16714-900-01

Atovaquone Oral Suspension, USP

750 mg/5 ml

Carton Label

ATOVAQUONE atovaquone suspension

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16714-900 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ATOVAQUONE (ATOVAQUONE) ATOVAQUONE 750 mg in 5 mL

Inactive Ingredients Ingredient Name Strength WATER POLOXAMER 188 HYPROMELLOSE, UNSPECIFIED BENZYL ALCOHOL XANTHAN GUM SACCHARIN SODIUM CITRIC ACID MONOHYDRATE TRISODIUM CITRATE DIHYDRATE

Product Characteristics Color YELLOW (bright yellow) Score Shape Size Flavor TUTTI FRUTTI (tutti frutti) Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:16714-900-01 210 mL in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA209685 03/01/2019

Labeler — Northstar Rx LLC (830546433)

Establishment
Name	Address	ID/FEI	Operations
Glenmark Pharmaceuticals Limited		676115028	MANUFACTURE (16714-900), ANALYSIS (16714-900)

Establishment
Name	Address	ID/FEI	Operations
Glenmark Pharmaceuticals Limited		650283737	API MANUFACTURE (16714-900)

Revised: 09/2019 Northstar Rx LLC