Details for New Drug Application (NDA): 213594
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The generic ingredient in OSELTAMIVIR PHOSPHATE is oseltamivir phosphate. There are eight drug master file entries for this compound. Thirty-two 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 |
Formulation / Manufacturing: | see details |
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) / 1 SUSPENSION 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 |
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