Details for New Drug Application (NDA): 079209
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The generic ingredient in FLUOXETINE HYDROCHLORIDE is fluoxetine hydrochloride. There are twenty-seven drug master file entries for this compound. Sixty-eight suppliers are listed for this compound. Additional details are available on the fluoxetine hydrochloride profile page.
Summary for 079209
Tradename: | FLUOXETINE HYDROCHLORIDE |
Applicant: | Aurobindo Pharma |
Ingredient: | fluoxetine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 079209
Mechanism of Action | Serotonin Uptake Inhibitors |
Medical Subject Heading (MeSH) Categories for 079209
Suppliers and Packaging for NDA: 079209
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FLUOXETINE HYDROCHLORIDE | fluoxetine hydrochloride | SOLUTION;ORAL | 079209 | ANDA | Major Pharmaceuticals | 0904-7195 | 0904-7195-94 | 40 CUP, UNIT-DOSE in 1 CASE (0904-7195-94) / 5 mL in 1 CUP, UNIT-DOSE (0904-7195-41) |
FLUOXETINE HYDROCHLORIDE | fluoxetine hydrochloride | SOLUTION;ORAL | 079209 | ANDA | Aurobindo Pharma Limited | 65862-306 | 65862-306-12 | 120 mL in 1 BOTTLE, GLASS (65862-306-12) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | EQ 20MG BASE/5ML | ||||
Approval Date: | Mar 20, 2009 | TE: | AA | RLD: | No |
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