Details for New Drug Application (NDA): 218009
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NDA 218009 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 218009
| Tradename: | OSELTAMIVIR PHOSPHATE |
| Applicant: | Zhejiang Poly Pharm |
| Ingredient: | oseltamivir phosphate |
| Patents: | 0 |
Pharmacology for NDA: 218009
| Mechanism of Action | Neuraminidase Inhibitors |
Medical Subject Heading (MeSH) Categories for 218009
Suppliers and Packaging for NDA: 218009
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| OSELTAMIVIR PHOSPHATE | oseltamivir phosphate | CAPSULE;ORAL | 218009 | ANDA | Slate Run Pharmaceuticals, LLC | 70436-225 | 70436-225-47 | 1 BLISTER PACK in 1 CARTON (70436-225-47) / 10 CAPSULE in 1 BLISTER PACK |
| OSELTAMIVIR PHOSPHATE | oseltamivir phosphate | CAPSULE;ORAL | 218009 | ANDA | Zhejiang Poly Pharm. Co., Ltd. | 72673-101 | 72673-101-10 | 1 BLISTER PACK in 1 CARTON (72673-101-10) / 10 CAPSULE in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 75MG BASE | ||||
| Approval Date: | Nov 24, 2023 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 30MG BASE | ||||
| Approval Date: | Oct 2, 2025 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 45MG BASE | ||||
| Approval Date: | Oct 2, 2025 | TE: | AB | RLD: | No | ||||
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