Details for New Drug Application (NDA): 212739
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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 212739
Tradename: | OSELTAMIVIR PHOSPHATE |
Applicant: | Sunshine |
Ingredient: | oseltamivir phosphate |
Patents: | 0 |
Pharmacology for NDA: 212739
Mechanism of Action | Neuraminidase Inhibitors |
Medical Subject Heading (MeSH) Categories for 212739
Suppliers and Packaging for NDA: 212739
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
OSELTAMIVIR PHOSPHATE | oseltamivir phosphate | CAPSULE;ORAL | 212739 | ANDA | Lannett Company, Inc. | 0527-4591 | 0527-4591-13 | 1 BLISTER PACK in 1 CARTON (0527-4591-13) / 10 CAPSULE in 1 BLISTER PACK |
OSELTAMIVIR PHOSPHATE | oseltamivir phosphate | CAPSULE;ORAL | 212739 | ANDA | Lannett Company, Inc. | 0527-4592 | 0527-4592-13 | 1 BLISTER PACK in 1 CARTON (0527-4592-13) / 10 CAPSULE in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 30MG BASE | ||||
Approval Date: | Mar 4, 2020 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 45MG BASE | ||||
Approval Date: | Mar 4, 2020 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 75MG BASE | ||||
Approval Date: | Mar 4, 2020 | TE: | AB | RLD: | No |
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