Details for New Drug Application (NDA): 209113
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NDA 209113 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, Laurus, Lupin, Macleods Pharms Ltd, MSN, Natco, Rising, Strides Pharma, Sunshine, Zydus Pharms, Ajanta Pharma Ltd, Alvogen, Amneal Pharms Ny, Aurobindo Pharma Ltd, Hetero Labs Ltd V, Leading, Oryza, and Teva Pharms Usa, and is included in thirty-one NDAs. It is available from thirty-four 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-five 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-five suppliers are listed for this compound. Additional details are available on the oseltamivir phosphate profile page.
Summary for 209113
| Tradename: | OSELTAMIVIR PHOSPHATE |
| Applicant: | Zydus Pharms |
| Ingredient: | oseltamivir phosphate |
| Patents: | 0 |
Pharmacology for NDA: 209113
| Mechanism of Action | Neuraminidase Inhibitors |
Medical Subject Heading (MeSH) Categories for 209113
Suppliers and Packaging for NDA: 209113
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| OSELTAMIVIR PHOSPHATE | oseltamivir phosphate | FOR SUSPENSION;ORAL | 209113 | ANDA | Preferred Pharmaceuticals Inc. | 68788-7600 | 68788-7600-6 | 1 BOTTLE in 1 CARTON (68788-7600-6) / 60 mL in 1 BOTTLE |
| OSELTAMIVIR PHOSPHATE | oseltamivir phosphate | FOR SUSPENSION;ORAL | 209113 | ANDA | Zydus Pharmaceuticals USA Inc. | 70710-1165 | 70710-1165-6 | 1 BOTTLE in 1 CARTON (70710-1165-6) / 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: | Sep 14, 2017 | TE: | AB | RLD: | No | ||||
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