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Generated: May 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078619

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NDA 078619 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 Co Inc, Pharm Assoc, Wockhardt Bio Ag, Alvogen, Fosun Pharma, Inventia Hlthcare, Par Form, Par Pharm Inc, and Torrent Pharms Ltd, and is included in forty-eight NDAs. It is available from seventy 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-two 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
Therapeutic Class:Antidepressants
Formulation / Manufacturing:see details
Pharmacology for NDA: 078619
Mechanism of ActionSerotonin Uptake Inhibitors
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, Inc dba Vangard Labs 0615-8183 N 0615-8183-39
FLUOXETINE HYDROCHLORIDE fluoxetine hydrochloride CAPSULE;ORAL 078619 ANDA Blenheim Pharmacal, Inc. 10544-065 E 10544-065-30

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 10MG BASE
Approval Date:Jan 31, 2008TE:AB1RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 20MG BASE
Approval Date:Jan 31, 2008TE:AB1RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 40MG BASE
Approval Date:Jan 31, 2008TE:ABRLD:No

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