Details for New Drug Application (NDA): 215538
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NDA 215538 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, MSN, Natco, Rising, Shandong, Strides Pharma, Sunshine, Upsher Smith Labs, 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-seven NDAs. It is available from thirty-five suppliers. Additional details are available on the OSELTAMIVIR PHOSPHATE profile page.
The generic ingredient in OSELTAMIVIR PHOSPHATE is oseltamivir phosphate. There is one drug master file entry for this compound. Thirty-six 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 is one drug master file entry for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the oseltamivir phosphate profile page.
Summary for 215538
| Tradename: | OSELTAMIVIR PHOSPHATE |
| Applicant: | Epic Pharma Llc |
| Ingredient: | oseltamivir phosphate |
| Patents: | 0 |
Pharmacology for NDA: 215538
| Mechanism of Action | Neuraminidase Inhibitors |
Medical Subject Heading (MeSH) Categories for 215538
Suppliers and Packaging for NDA: 215538
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| OSELTAMIVIR PHOSPHATE | oseltamivir phosphate | FOR SUSPENSION;ORAL | 215538 | ANDA | EPIC PHARMA, LLC | 42806-363 | 42806-363-13 | 1 BOTTLE, GLASS in 1 CARTON (42806-363-13) / 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 14, 2023 | TE: | AB | RLD: | No | ||||
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