Details for New Drug Application (NDA): 021246
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The generic ingredient in TAMIFLU 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 021246
Tradename: | TAMIFLU |
Applicant: | Roche |
Ingredient: | oseltamivir phosphate |
Patents: | 0 |
Pharmacology for NDA: 021246
Mechanism of Action | Neuraminidase Inhibitors |
Medical Subject Heading (MeSH) Categories for 021246
Suppliers and Packaging for NDA: 021246
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TAMIFLU | oseltamivir phosphate | FOR SUSPENSION;ORAL | 021246 | NDA | Genentech, Inc. | 0004-0822 | 0004-0822-05 | 1 BOTTLE, GLASS in 1 CARTON (0004-0822-05) / 60 mL in 1 BOTTLE, GLASS |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | FOR SUSPENSION;ORAL | Strength | EQ 12MG BASE/ML | ||||
Approval Date: | Dec 14, 2000 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | EQ 6MG BASE/ML | ||||
Approval Date: | Mar 21, 2011 | TE: | AB | RLD: | Yes |
Expired US Patents for NDA 021246
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Roche | TAMIFLU | oseltamivir phosphate | FOR SUSPENSION;ORAL | 021246-001 | Dec 14, 2000 | ⤷ Sign Up | ⤷ Sign Up |
Roche | TAMIFLU | oseltamivir phosphate | FOR SUSPENSION;ORAL | 021246-002 | Mar 21, 2011 | ⤷ Sign Up | ⤷ Sign Up |
Roche | TAMIFLU | oseltamivir phosphate | FOR SUSPENSION;ORAL | 021246-002 | Mar 21, 2011 | ⤷ Sign Up | ⤷ Sign Up |
Roche | TAMIFLU | oseltamivir phosphate | FOR SUSPENSION;ORAL | 021246-001 | Dec 14, 2000 | ⤷ Sign Up | ⤷ Sign Up |
Roche | TAMIFLU | oseltamivir phosphate | FOR SUSPENSION;ORAL | 021246-002 | Mar 21, 2011 | ⤷ Sign Up | ⤷ Sign Up |
Roche | TAMIFLU | oseltamivir phosphate | FOR SUSPENSION;ORAL | 021246-001 | Dec 14, 2000 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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