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Generated: December 12, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075245

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NDA 075245 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, Mallinckrodt, Mylan, Mylan Pharms Inc, Par Pharm, Sandoz, Sciegen Pharms Inc, 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, Alvogen, Dr Reddys Labs Inc, Par Form, Par Pharm Inc, and Torrent Pharms Ltd, and is included in forty-seven NDAs. It is available from sixty-eight 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 075245

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Antidepressants
Formulation / Manufacturing:see details

Pharmacology for NDA: 075245

Mechanism of ActionSerotonin Uptake Inhibitors

Suppliers and Packaging for NDA: 075245

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUOXETINE HYDROCHLORIDE fluoxetine hydrochloride CAPSULE;ORAL 075245 ANDA KAISER FOUNDATION HOSPITALS 0179-0060 0179-0060-30 30 CAPSULE in 1 BOTTLE (0179-0060-30)
FLUOXETINE HYDROCHLORIDE fluoxetine hydrochloride CAPSULE;ORAL 075245 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-1357 0615-1357-31 31 CAPSULE in 1 BLISTER PACK (0615-1357-31)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 20MG BASE
Approval Date:Jan 31, 2002TE:AB1RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 10MG BASE
Approval Date:Jan 31, 2002TE:AB1RLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 40MG BASE
Approval Date:Sep 28, 2004TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

McKesson
Julphar
Colorcon
McKinsey
UBS
Johnson and Johnson
AstraZeneca
US Army
Farmers Insurance
Cantor Fitzgerald

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