Details for New Drug Application (NDA): 078619
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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 078619
Tradename: | FLUOXETINE HYDROCHLORIDE |
Applicant: | Aurobindo Pharma |
Ingredient: | fluoxetine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 078619
Mechanism of Action | Serotonin Uptake Inhibitors |
Medical Subject Heading (MeSH) Categories for 078619
Suppliers and Packaging for NDA: 078619
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FLUOXETINE HYDROCHLORIDE | fluoxetine hydrochloride | CAPSULE;ORAL | 078619 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8183 | 0615-8183-05 | 15 CAPSULE in 1 BLISTER PACK (0615-8183-05) |
FLUOXETINE HYDROCHLORIDE | fluoxetine hydrochloride | CAPSULE;ORAL | 078619 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8183 | 0615-8183-39 | 30 CAPSULE in 1 BLISTER PACK (0615-8183-39) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 10MG BASE | ||||
Approval Date: | Jan 31, 2008 | TE: | AB1 | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 20MG BASE | ||||
Approval Date: | Jan 31, 2008 | TE: | AB1 | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 40MG BASE | ||||
Approval Date: | Jan 31, 2008 | TE: | AB | RLD: | No |
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