Details for New Drug Application (NDA): 078572
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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 suppliers are listed for this compound. Additional details are available on the fluoxetine hydrochloride profile page.
Summary for 078572
Tradename: | FLUOXETINE HYDROCHLORIDE |
Applicant: | Dr Reddys Labs Ltd |
Ingredient: | fluoxetine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 078572
Mechanism of Action | Serotonin Uptake Inhibitors |
Medical Subject Heading (MeSH) Categories for 078572
Suppliers and Packaging for NDA: 078572
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FLUOXETINE HYDROCHLORIDE | fluoxetine hydrochloride | CAPSULE, DELAYED REL PELLETS;ORAL | 078572 | ANDA | Dr.Reddy's Laboratories Limited | 55111-284 | 55111-284-48 | 1 BLISTER PACK in 1 CARTON (55111-284-48) / 4 CAPSULE, DELAYED RELEASE PELLETS in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, DELAYED REL PELLETS;ORAL | Strength | EQ 90MG BASE | ||||
Approval Date: | Mar 22, 2010 | TE: | RLD: | No |
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