Details for New Drug Application (NDA): 212858
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NDA 212858 describes OSELTAMIVIR PHOSPHATE, which is a drug marketed by Accord Hlthcare, Alembic, Amneal Pharms, Epic Pharma Llc, Hainan Poly, Hetero Labs Ltd Iii, Invagen Pharms, Lupin, Macleods Pharms Ltd, MSN, Natco, Rising, Strides Pharma, Sunshine, Zydus Pharms, Ajanta Pharma Ltd, Alvogen, Amneal Pharms Ny, Aptapharma Inc, Chemistry Hlth, Hetero Labs Ltd V, and Teva Pharms Usa, and is included in twenty-eight NDAs. It is available from thirty-one suppliers. Additional details are available on the OSELTAMIVIR PHOSPHATE profile page.
The generic ingredient in OSELTAMIVIR PHOSPHATE is oseltamivir phosphate. There are eight drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the oseltamivir phosphate profile page.
The generic ingredient in OSELTAMIVIR PHOSPHATE is oseltamivir phosphate. There are eight drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the oseltamivir phosphate profile page.
Summary for 212858
| Tradename: | OSELTAMIVIR PHOSPHATE |
| Applicant: | Aptapharma Inc |
| Ingredient: | oseltamivir phosphate |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 212858
| Mechanism of Action | Neuraminidase Inhibitors |
Medical Subject Heading (MeSH) Categories for 212858
Suppliers and Packaging for NDA: 212858
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| OSELTAMIVIR PHOSPHATE | oseltamivir phosphate | FOR SUSPENSION;ORAL | 212858 | ANDA | Cipla USA, Inc | 69097-904 | 69097-904-43 | 1 BOTTLE in 1 CARTON (69097-904-43) / 60 mL in 1 BOTTLE |
| OSELTAMIVIR PHOSPHATE | oseltamivir phosphate | FOR SUSPENSION;ORAL | 212858 | ANDA | Exelan Pharmaceuticals, Inc. | 76282-739 | 76282-739-52 | 1 BOTTLE in 1 CARTON (76282-739-52) / 60 mL in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | EQ 6MG BASE/ML | ||||
| Approval Date: | Aug 30, 2021 | TE: | AB | RLD: | No | ||||
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