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Details for New Drug Application (NDA): 075207

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NDA 075207 describes FLUOXETINE HYDROCHLORIDE, which is a drug marketed by Teva Pharms Usa, Barr, Teva, Dr Reddys Labs Inc, Mylan, Sandoz, Aurobindo Pharm, Wockhardt, Pharm Assoc, Aurobindo Pharma, Mallinckrodt, Carlsbad, Par Pharm, Alembic Pharms Ltd, Hi Tech Pharma, Edgemont Pharms Llc, 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-five NDAs. It is available from sixty-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-one suppliers are listed for this compound. Additional details are available on the fluoxetine hydrochloride profile page.

Summary for NDA: 075207

Tradename:
FLUOXETINE HYDROCHLORIDE
Applicant:
Mylan
Ingredient:
fluoxetine hydrochloride
Patents:0
Therapeutic Class:Antidepressants
Formulation / Manufacturing:see details

Pharmacology for NDA: 075207

Mechanism of ActionSerotonin Uptake Inhibitors

Suppliers and Packaging for NDA: 075207

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUOXETINE HYDROCHLORIDE
fluoxetine hydrochloride
CAPSULE;ORAL 075207 ANDA State of Florida DOH Central Pharmacy 53808-0836 53808-0836-1 30 CAPSULE in 1 BLISTER PACK (53808-0836-1)
FLUOXETINE HYDROCHLORIDE
fluoxetine hydrochloride
CAPSULE;ORAL 075207 ANDA Physicians Total Care, Inc. 54868-4537 54868-4537-0 30 CAPSULE in 1 BOTTLE, PLASTIC (54868-4537-0)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 10MG BASE
Approval Date:Jan 30, 2002TE:AB1RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 20MG BASE
Approval Date:Jan 30, 2002TE:AB1RLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 40MG BASE
Approval Date:May 25, 2007TE:ABRLD:No


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