Details for New Drug Application (NDA): 209590
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The generic ingredient in OSELTAMIVIR PHOSPHATE is oseltamivir phosphate. There are eight drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the oseltamivir phosphate profile page.
Summary for 209590
Tradename: | OSELTAMIVIR PHOSPHATE |
Applicant: | Hetero Labs Ltd V |
Ingredient: | oseltamivir phosphate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 209590
Mechanism of Action | Neuraminidase Inhibitors |
Medical Subject Heading (MeSH) Categories for 209590
Suppliers and Packaging for NDA: 209590
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
OSELTAMIVIR PHOSPHATE | oseltamivir phosphate | FOR SUSPENSION;ORAL | 209590 | ANDA | Camber Pharmaceuticals, Inc. | 31722-108 | 31722-108-60 | 360 mL in 1 BOTTLE (31722-108-60) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | EQ 6MG BASE/ML | ||||
Approval Date: | Mar 28, 2022 | TE: | AB | RLD: | No |
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