Details for New Drug Application (NDA): 215538
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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 215538
Tradename: | OSELTAMIVIR PHOSPHATE |
Applicant: | Epic Pharma Llc |
Ingredient: | oseltamivir phosphate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 215538
Mechanism of Action | Neuraminidase Inhibitors |
Medical Subject Heading (MeSH) Categories for 215538
Suppliers and Packaging for NDA: 215538
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
OSELTAMIVIR PHOSPHATE | oseltamivir phosphate | FOR SUSPENSION;ORAL | 215538 | ANDA | EPIC PHARMA, LLC | 42806-363 | 42806-363-13 | 1 BOTTLE, GLASS in 1 CARTON (42806-363-13) / 60 mL in 1 BOTTLE, GLASS |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | EQ 6MG BASE/ML | ||||
Approval Date: | Feb 14, 2023 | TE: | AB | RLD: | No |
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