You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: November 24, 2024

Details for New Drug Application (NDA): 212683


✉ Email this page to a colleague

« Back to Dashboard


NDA 212683 describes FLUOXETINE HYDROCHLORIDE, which is a drug marketed by Barr, Dr Reddys Labs Ltd, Accord Hlthcare, Alembic Pharms Ltd, Ani Pharms, Apnar Pharma Lp, Aurobindo Pharma, Beximco Pharms Usa, Cadila Pharms Ltd, Carlsbad, Cr Double Crane, Granules, Heritage, Ivax Sub Teva Pharms, Landela Pharm, Marksans Pharma, Micro Labs, Natco Pharma Usa, Norvium Bioscience, Sandoz, Sciegen Pharms Inc, Specgx Llc, Strides Pharma, Sun Pharm Inds Ltd, Teva, Teva Pharms Usa, Actavis Mid Atlantic, Bajaj, Chartwell Molecular, Lannett Co Inc, Nostrum Labs Inc, Novitium Pharma, Pharm Assoc, Pharmobedient Cnsltg, Upsher Smith Labs, Alembic, Aurobindo Pharma Ltd, Dr Reddys, Endo Operations, Fosun Pharma, G And W Labs Inc, Inventia Hlthcare, Lupin Ltd, Rising, Slate Run Pharma, Taro, Torrent, and Twi Pharms, and is included in sixty-seven NDAs. It is available from seventy 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 212683
Tradename:FLUOXETINE HYDROCHLORIDE
Applicant:Strides Pharma
Ingredient:fluoxetine hydrochloride
Patents:0
Pharmacology for NDA: 212683
Mechanism of ActionSerotonin Uptake Inhibitors
Suppliers and Packaging for NDA: 212683
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUOXETINE HYDROCHLORIDE fluoxetine hydrochloride TABLET;ORAL 212683 ANDA Strides Pharma Science Limited 64380-900 64380-900-04 30 TABLET in 1 BOTTLE (64380-900-04)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 60MG BASE
Approval Date:Sep 13, 2024TE:ABRLD:No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

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 verification 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.