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Federal Trade Commission
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Generated: March 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076001

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NDA 076001 describes FLUOXETINE HYDROCHLORIDE, which is a drug marketed by Barr, Dr Reddys Labs Ltd, Alembic Pharms Ltd, Ani Pharms Inc, Aurobindo Pharma, Carlsbad, Cr Double Crane, Heritage Pharms Inc, Ivax Sub Teva Pharms, Landela Pharm, Mylan, Mylan Pharms Inc, Par Pharm, Sandoz, Sciegen Pharms Inc, Specgx Llc, Sun Pharm Inds Ltd, Teva, Teva Pharms Usa, Wockhardt Ltd, Actavis Mid Atlantic, Apotex Inc, Aurobindo Pharma Ltd, Hi Tech Pharma, Lannett, Pharm Assoc, Silarx, Wockhardt Bio Ag, Alvogen, Dr Reddys Labs Inc, Fosun Pharma, Inventia Hlthcare, Par Form, Par Pharm Inc, and Torrent Pharms Ltd, and is included in forty-eight NDAs. It is available from sixty-nine 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. Seventy-one suppliers are listed for this compound. Additional details are available on the fluoxetine hydrochloride profile page.
Summary for 076001
Applicant:Teva Pharms Usa
Ingredient:fluoxetine hydrochloride
Therapeutic Class:Antidepressants
Formulation / Manufacturing:see details
Pharmacology for NDA: 076001
Mechanism of ActionSerotonin Uptake Inhibitors
Suppliers and Packaging for NDA: 076001
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUOXETINE HYDROCHLORIDE fluoxetine hydrochloride CAPSULE;ORAL 076001 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-7625 N 0615-7625-39
FLUOXETINE HYDROCHLORIDE fluoxetine hydrochloride CAPSULE;ORAL 076001 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-7638 N 0615-7638-39

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 10MG BASE
Approval Date:Jan 29, 2002TE:AB1RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 20MG BASE
Approval Date:Jan 29, 2002TE:AB1RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
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Express Scripts
US Army

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