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Serving leading biopharmaceutical companies globally:

Moodys
Harvard Business School
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Boehringer Ingelheim
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Generated: December 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204597

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NDA 204597 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 204597

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

Pharmacology for NDA: 204597

Mechanism of ActionSerotonin Uptake Inhibitors

Suppliers and Packaging for NDA: 204597

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUOXETINE HYDROCHLORIDE fluoxetine hydrochloride CAPSULE;ORAL 204597 ANDA Camber Pharmaceuticals, Inc. 31722-903 31722-903-05 500 CAPSULE in 1 BOTTLE (31722-903-05)
FLUOXETINE HYDROCHLORIDE fluoxetine hydrochloride CAPSULE;ORAL 204597 ANDA Camber Pharmaceuticals, Inc. 31722-903 31722-903-10 1000 CAPSULE in 1 BOTTLE (31722-903-10)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 10MG BASE
Approval Date:Mar 16, 2015TE:AB1RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 20MG BASE
Approval Date:Mar 16, 2015TE:AB1RLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 40MG BASE
Approval Date:Mar 16, 2015TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Moodys
Queensland Health
Deloitte
Merck
UBS
Fish and Richardson
Accenture
Daiichi Sankyo
Mallinckrodt
Healthtrust

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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