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Generated: April 27, 2017

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Details for New Drug Application (NDA): 075245

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NDA 075245 describes FLUOXETINE HYDROCHLORIDE, which is a drug marketed by Teva Pharms Usa, Barr, Teva, Dr Reddys Labs Inc, Mylan, Sandoz, Aurobindo Pharma Ltd, Wockhardt, Pharm Assoc, Aurobindo Pharma, Mallinckrodt, Carlsbad, Par Pharm, Alembic Pharms Ltd, Hi Tech Pharma, Alvogen, Heritage Pharms Inc, Par Form, Torrent Pharms Ltd, Wockhardt Ltd, Ivax Sub Teva Pharms, Silarx, Lannett, Landela Pharm, Cr Double Crane, Dr Reddys Labs Ltd, Mylan Pharms Inc, Ani Pharms Inc, Sun Pharm Inds Ltd, Actavis Mid Atlantic, Apotex Inc, and Sciegen Pharms Inc, and is included in forty-six NDAs. It is available from sixty-five 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-nine suppliers are listed for this compound. Additional details are available on the fluoxetine hydrochloride profile page.

Summary for NDA: 075245

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
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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