Details for New Drug Application (NDA): 218565
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NDA 218565 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 218565
| Tradename: | OSELTAMIVIR PHOSPHATE |
| Applicant: | Laurus |
| Ingredient: | oseltamivir phosphate |
| Patents: | 0 |
Pharmacology for NDA: 218565
| Mechanism of Action | Neuraminidase Inhibitors |
Medical Subject Heading (MeSH) Categories for 218565
Suppliers and Packaging for NDA: 218565
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| OSELTAMIVIR PHOSPHATE | oseltamivir phosphate | CAPSULE;ORAL | 218565 | ANDA | Laurus Labs Limited | 42385-985 | 42385-985-01 | 100 CAPSULE in 1 BOTTLE (42385-985-01) |
| OSELTAMIVIR PHOSPHATE | oseltamivir phosphate | CAPSULE;ORAL | 218565 | ANDA | Laurus Labs Limited | 42385-985 | 42385-985-11 | 1 BLISTER PACK in 1 CARTON (42385-985-11) / 10 CAPSULE in 1 BLISTER PACK (42385-985-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 30MG BASE | ||||
| Approval Date: | May 1, 2024 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 45MG BASE | ||||
| Approval Date: | May 1, 2024 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 75MG BASE | ||||
| Approval Date: | May 1, 2024 | TE: | AB | RLD: | No | ||||
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