Details for New Drug Application (NDA): 210935
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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 210935
Tradename: | FLUOXETINE HYDROCHLORIDE |
Applicant: | Sciegen Pharms Inc |
Ingredient: | fluoxetine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 210935
Mechanism of Action | Serotonin Uptake Inhibitors |
Medical Subject Heading (MeSH) Categories for 210935
Suppliers and Packaging for NDA: 210935
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FLUOXETINE HYDROCHLORIDE | fluoxetine hydrochloride | TABLET;ORAL | 210935 | ANDA | ScieGen Pharmaceuticals, Inc | 50228-420 | 50228-420-01 | 100 TABLET, FILM COATED in 1 BOTTLE (50228-420-01) |
FLUOXETINE HYDROCHLORIDE | fluoxetine hydrochloride | TABLET;ORAL | 210935 | ANDA | ScieGen Pharmaceuticals, Inc | 50228-420 | 50228-420-10 | 1000 TABLET, FILM COATED in 1 BOTTLE (50228-420-10) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 10MG BASE | ||||
Approval Date: | Mar 20, 2019 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 20MG BASE | ||||
Approval Date: | Mar 20, 2019 | TE: | AB | RLD: | No |
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