Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Generated: July 23, 2019

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, Beximco Pharms Usa, Cadila Pharms Ltd, Carlsbad, Cr Double Crane, Heritage Pharms Inc, Ivax Sub Teva Pharms, Landela Pharm, Marksans Pharma, 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, Aurobindo Pharma Ltd, Hi Tech Pharma, Lannett Co Inc, Nostrum Labs Inc, Pharm Assoc, Wockhardt Bio Ag, Alvogen, Appco Pharma Llc, Fosun Pharma, Inventia Hlthcare, Lupin Ltd, Par Form, Par Pharm Inc, Torrent, and Upsher Smith Labs, and is included in fifty-seven NDAs. It is available from seventy-seven 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-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 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 0615-8183-39 30 CAPSULE in 1 BLISTER PACK (0615-8183-39)
FLUOXETINE HYDROCHLORIDE fluoxetine hydrochloride CAPSULE;ORAL 078619 ANDA Blenheim Pharmacal, Inc. 10544-065 10544-065-30 30 CAPSULE in 1 BOTTLE (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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