Details for New Drug Application (NDA): 077849
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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-nine suppliers are listed for this compound. Additional details are available on the fluoxetine hydrochloride profile page.
Summary for 077849
Tradename: | FLUOXETINE HYDROCHLORIDE |
Applicant: | Lannett Co Inc |
Ingredient: | fluoxetine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 077849
Mechanism of Action | Serotonin Uptake Inhibitors |
Medical Subject Heading (MeSH) Categories for 077849
Suppliers and Packaging for NDA: 077849
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FLUOXETINE HYDROCHLORIDE | fluoxetine hydrochloride | SOLUTION;ORAL | 077849 | ANDA | Lannett Company, Inc. | 54838-523 | 54838-523-40 | 120 mL in 1 BOTTLE, PLASTIC (54838-523-40) |
FLUOXETINE HYDROCHLORIDE | fluoxetine hydrochloride | SOLUTION;ORAL | 077849 | ANDA | American Health Packaging | 60687-244 | 60687-244-77 | 4 TRAY in 1 CASE (60687-244-77) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-244-46) / 5 mL in 1 CUP, UNIT-DOSE (60687-244-40) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | EQ 20MG BASE/5ML | ||||
Approval Date: | Feb 9, 2007 | TE: | AA | RLD: | No |
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