Details for New Drug Application (NDA): 209438
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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 209438
Tradename: | OSELTAMIVIR PHOSPHATE |
Applicant: | Hetero Labs Ltd Iii |
Ingredient: | oseltamivir phosphate |
Patents: | 0 |
Pharmacology for NDA: 209438
Mechanism of Action | Neuraminidase Inhibitors |
Medical Subject Heading (MeSH) Categories for 209438
Suppliers and Packaging for NDA: 209438
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
OSELTAMIVIR PHOSPHATE | oseltamivir phosphate | CAPSULE;ORAL | 209438 | ANDA | Camber Pharmaceuticals, Inc. | 31722-630 | 31722-630-31 | 10 CAPSULE in 1 CARTON (31722-630-31) |
OSELTAMIVIR PHOSPHATE | oseltamivir phosphate | CAPSULE;ORAL | 209438 | ANDA | Camber Pharmaceuticals, Inc. | 31722-631 | 31722-631-31 | 10 CAPSULE in 1 CARTON (31722-631-31) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 30MG BASE | ||||
Approval Date: | Feb 23, 2018 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 45MG BASE | ||||
Approval Date: | Feb 23, 2018 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 75MG BASE | ||||
Approval Date: | Feb 23, 2018 | TE: | AB | RLD: | No |
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