Details for New Drug Application (NDA): 208348
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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 208348
Tradename: | OSELTAMIVIR PHOSPHATE |
Applicant: | Lupin |
Ingredient: | oseltamivir phosphate |
Patents: | 0 |
Pharmacology for NDA: 208348
Mechanism of Action | Neuraminidase Inhibitors |
Medical Subject Heading (MeSH) Categories for 208348
Suppliers and Packaging for NDA: 208348
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
OSELTAMIVIR PHOSPHATE | oseltamivir phosphate | CAPSULE;ORAL | 208348 | ANDA | RPK Pharmaceuticals, Inc. | 53002-3710 | 53002-3710-1 | 1 BLISTER PACK in 1 CARTON (53002-3710-1) / 10 CAPSULE in 1 BLISTER PACK |
OSELTAMIVIR PHOSPHATE | oseltamivir phosphate | CAPSULE;ORAL | 208348 | ANDA | Redpharm Drug | 67296-1647 | 67296-1647-1 | 1 BLISTER PACK in 1 CARTON (67296-1647-1) / 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: | Jan 9, 2018 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 45MG BASE | ||||
Approval Date: | Jan 9, 2018 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 75MG BASE | ||||
Approval Date: | Jan 9, 2018 | TE: | AB | RLD: | No |
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