Details for New Drug Application (NDA): 078619
✉ Email this page to a colleague
NDA 078619 describes FLUOXETINE HYDROCHLORIDE, which is a drug marketed by Barr, Dr Reddys Labs Ltd, Accord Hlthcare, Alembic Pharms Ltd, Ani Pharms, Apnar Pharma Lp, Aurobindo Pharma, Cadila Pharms Ltd, Carlsbad, Chartwell Rx, Cr Double Crane, Heritage, Ivax Sub Teva Pharms, Landela Pharm, Marksans Pharma, Micro Labs, Natco Pharma Usa, Pharmobedient, Regcon Holdings, Sandoz, Sciegen Pharms Inc, Specgx Llc, Strides Pharma Intl, Sun Pharm Inds Ltd, Teva, Teva Pharms Usa, Actavis Mid Atlantic, Bajaj, Chartwell Molecular, Lannett Co Inc, Novitium Pharma, Pharm Assoc, Pharmobedient Cnsltg, Solis Pharms, Upsher Smith Labs, Alembic, Appco, Aurobindo Pharma Ltd, Dr Reddys, Fosun Pharma, G And W Labs Inc, Inventia Hlthcare, Lupin Ltd, Ph Health, Rising, Strides Pharma, Torrent, and Twi Pharms, and is included in sixty-seven NDAs. It is available from sixty-six suppliers. Additional details are available on the FLUOXETINE HYDROCHLORIDE profile page.
The generic ingredient in FLUOXETINE HYDROCHLORIDE is fluoxetine hydrochloride. There are twenty-seven drug master file entries for this compound. Sixty-seven suppliers are listed for this compound. Additional details are available on the fluoxetine hydrochloride profile page.
The generic ingredient in FLUOXETINE HYDROCHLORIDE is fluoxetine hydrochloride. There are twenty-seven drug master file entries for this compound. Sixty-seven 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 |
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 | ||||
Complete Access Available with Subscription
