Label: OSELTAMIVIR PHOSPHATE- oseltamivir acid suspension
- NDC Code(s): 70771-1598-6
- Packager: Cadila Healthcare Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated August 5, 2021
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INGREDIENTS AND APPEARANCE
OSELTAMIVIR PHOSPHATE
oseltamivir acid suspensionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1598 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OSELTAMIVIR PHOSPHATE (UNII: 4A3O49NGEZ) (OSELTAMIVIR ACID - UNII:K6106LV5Q8) OSELTAMIVIR ACID 6 mg in 1 mL Inactive Ingredients Ingredient Name Strength MONOSODIUM CITRATE (UNII: 68538UP9SE) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM BENZOATE (UNII: OJ245FE5EU) SORBITOL (UNII: 506T60A25R) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color WHITE (White) Score Shape Size Flavor TUTTI FRUTTI Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1598-6 60 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/05/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA209113 08/05/2021 Labeler - Cadila Healthcare Limited (918596198) Establishment Name Address ID/FEI Business Operations CADILA HEALTHCARE LIMITED 677605858 ANALYSIS(70771-1598) , MANUFACTURE(70771-1598)
