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Generated: July 26, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203836

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NDA 203836 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-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: 203836

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

Pharmacology for NDA: 203836

Mechanism of ActionSerotonin Uptake Inhibitors

Suppliers and Packaging for NDA: 203836

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUOXETINE HYDROCHLORIDE
fluoxetine hydrochloride
TABLET;ORAL 203836 ANDA Par Pharmaceutical Inc. 49884-335 49884-335-01 100 TABLET, COATED in 1 BOTTLE, PLASTIC (49884-335-01)
FLUOXETINE HYDROCHLORIDE
fluoxetine hydrochloride
TABLET;ORAL 203836 ANDA Par Pharmaceutical Inc. 49884-335 49884-335-10 1000 TABLET, COATED in 1 BOTTLE, PLASTIC (49884-335-10)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Aug 19, 2016TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 20MG BASE
Approval Date:Aug 19, 2016TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

Novartis
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Cantor Fitzgerald
Fish and Richardson
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Healthtrust
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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