Details for New Drug Application (NDA): 213594
✉ Email this page to a colleague
NDA 213594 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, 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-six 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 are eight drug master file entries 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 are eight drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the oseltamivir phosphate profile page.
Summary for 213594
| Tradename: | OSELTAMIVIR PHOSPHATE |
| Applicant: | Sunshine |
| Ingredient: | oseltamivir phosphate |
| Patents: | 0 |
Pharmacology for NDA: 213594
| Mechanism of Action | Neuraminidase Inhibitors |
Medical Subject Heading (MeSH) Categories for 213594
Suppliers and Packaging for NDA: 213594
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| OSELTAMIVIR PHOSPHATE | oseltamivir phosphate | FOR SUSPENSION;ORAL | 213594 | ANDA | Lannett Company, Inc. | 0527-5137 | 0527-5137-62 | 1 BOTTLE, PLASTIC in 1 CARTON (0527-5137-62) / 60 mL in 1 BOTTLE, PLASTIC |
| OSELTAMIVIR PHOSPHATE | oseltamivir phosphate | FOR SUSPENSION;ORAL | 213594 | ANDA | A-S Medication Solutions | 50090-7346 | 50090-7346-0 | 1 BOTTLE, PLASTIC in 1 CARTON (50090-7346-0) / 60 mL in 1 BOTTLE, PLASTIC |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | EQ 6MG BASE/ML | ||||
| Approval Date: | Jan 5, 2022 | TE: | AB | RLD: | No | ||||
Complete Access Available with Subscription
