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Serving leading biopharmaceutical companies globally:

McKinsey
Healthtrust
Cipla
Merck
Harvard Business School
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Argus Health
Queensland Health
Dow
Boehringer Ingelheim

Generated: December 12, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202133

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NDA 202133 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 202133

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

Pharmacology for NDA: 202133

Mechanism of ActionSerotonin Uptake Inhibitors

Suppliers and Packaging for NDA: 202133

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUOXETINE HYDROCHLORIDE fluoxetine hydrochloride TABLET;ORAL 202133 NDA Alvogen Inc. 47781-600 47781-600-30 30 TABLET, FILM COATED in 1 BOTTLE (47781-600-30)
FLUOXETINE HYDROCHLORIDE fluoxetine hydrochloride TABLET;ORAL 202133 NDA Edgemont Pharmaceuticals, LLC 49909-005 49909-005-30 30 TABLET, FILM COATED in 1 BOTTLE (49909-005-30)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 60MG BASE
Approval Date:Oct 6, 2011TE:ABRLD:Yes


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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Baxter
Teva
Mallinckrodt
Queensland Health
McKesson
Merck
Federal Trade Commission
Healthtrust
Accenture

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