Details for New Drug Application (NDA): 208347
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NDA 208347 describes OSELTAMIVIR PHOSPHATE, which is a drug marketed by Accord Hlthcare, Alembic, Amneal Pharms, Beijing Jialin, Cediprof Inc, Epic Pharma Llc, Hetero Labs Ltd Iii, Invagen Pharms, Laurus, Lupin, Macleods Pharms Ltd, MSN, Natco, Rising, Shandong, Strides Pharma, Sunshine, Zhejiang Poly Pharm, Zydus Pharms, Ajanta Pharma Ltd, Alvogen, Amneal Pharms Ny, Aurobindo Pharma Ltd, Hetero Labs Ltd V, Jubilant Generics, Leading, Pharmobedient, and Teva Pharms Usa, and is included in thirty-five 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 208347
| Tradename: | OSELTAMIVIR PHOSPHATE |
| Applicant: | Lupin |
| Ingredient: | oseltamivir phosphate |
| Patents: | 0 |
Pharmacology for NDA: 208347
| Mechanism of Action | Neuraminidase Inhibitors |
Medical Subject Heading (MeSH) Categories for 208347
Suppliers and Packaging for NDA: 208347
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| OSELTAMIVIR PHOSPHATE | oseltamivir phosphate | FOR SUSPENSION;ORAL | 208347 | ANDA | A-S Medication Solutions | 50090-4188 | 50090-4188-0 | 1 BOTTLE, GLASS in 1 CARTON (50090-4188-0) / 60 mL in 1 BOTTLE, GLASS |
| OSELTAMIVIR PHOSPHATE | oseltamivir phosphate | FOR SUSPENSION;ORAL | 208347 | ANDA | Lupin Pharmaceuticals, Inc. | 68180-678 | 68180-678-01 | 1 BOTTLE, GLASS in 1 CARTON (68180-678-01) / 60 mL in 1 BOTTLE, GLASS |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | EQ 6MG BASE/ML | ||||
| Approval Date: | Feb 20, 2018 | TE: | AB | RLD: | No | ||||
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