Details for New Drug Application (NDA): 212683
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The generic ingredient in FLUOXETINE HYDROCHLORIDE is fluoxetine hydrochloride. There are twenty-seven drug master file entries for this compound. Seventy-one suppliers are listed for this compound. Additional details are available on the fluoxetine hydrochloride profile page.
Summary for 212683
Tradename: | FLUOXETINE HYDROCHLORIDE |
Applicant: | Strides Pharma |
Ingredient: | fluoxetine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 212683
Mechanism of Action | Serotonin Uptake Inhibitors |
Medical Subject Heading (MeSH) Categories for 212683
Suppliers and Packaging for NDA: 212683
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FLUOXETINE HYDROCHLORIDE | fluoxetine hydrochloride | TABLET;ORAL | 212683 | ANDA | Strides Pharma Science Limited | 64380-900 | 64380-900-04 | 30 TABLET in 1 BOTTLE (64380-900-04) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 60MG BASE | ||||
Approval Date: | Sep 13, 2024 | TE: | AB | RLD: | No |
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