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NDA

FLUOXETINE HYDROCHLORIDE | N021860 | ALLERGAN PHARMACEUTICALS INTERNATIONAL LTD

3 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain13 active DMFs8 inactive

11 active API suppliers hold Drug Master Files for this ingredient.

OLON SPAFLUOXETINE HYDROCHLORIDE

DMF 86951990

ERREGIERRE SPAFLUOXETINE HYDROCHLORIDE USP-EP

DMF 108371994

FERMION OYFLUOXETINE HYDROCHLORIDE USP

DMF 113151995

OLON SPAFLUOXETINE HYDROCHLORIDE

DMF 120091996

QUIMICA SINTETICA SAFLUOXETINE HYDROCHLORIDE

DMF 122911996

DR REDDYS LABORATORIES LTDFLUOXETINE HYDROCHLORIDE USP

DMF 130691998

CADILA PHARMACEUTICALS LTDFLUOXETINE HYDROCHLORIDE USP

DMF 142531999

APITORIA PHARMA PRIVATE LTDFLUOXETINE HYDROCHLORIDE USP

DMF 189802005

SIEGFRIED LTDFLUOXETINE HYDROCHLORIDE

DMF 217682008

ALEMBIC PHARMACEUTICALS LTDFLUOXETINE HYDROCHLORIDE USP

DMF 257782012

APITORIA PHARMA PRIVATE LTDFLUOXETINE HYDROCHLORIDE USP (PROCESS II)

DMF 339402019

IPCA LABORATORIES LTDFLUOXETINE HYDROCHLORIDE USP

DMF 409692024

CHEMECA DRUGS PRIVATE LTDFLUOXETINE HYDROCHLORIDE USP

DMF 426682025

NATCO PHARMA LTDInactiveFLUOXETINE HYDROCHLORIDE

DMF 119921996

INDUSTRIALE CHIMICA SRLInactiveFLUOXETINE HYDROCHLORIDE

DMF 122921996

SIEGFRIED LTDInactiveFLUOXETINE HYDROCHLORIDE

DMF 124371997

BASF PHARMACHEMIKALIEN GMBH CO KGInactiveFLUOXETINE HYDROCHLORIDE

DMF 130261998

WOCKHARDT LTDInactiveFLUOXETINE HYDROCHLORIDE

DMF 142891999

RANBAXY LABORATORIES LTDInactiveFLUOXETINE HYDROCHLORIDE

DMF 153622001

WOCKHARDT LTDInactiveFLUOXETINE HYDROCHLORIDE USP

DMF 181772005

CHANGZHOU SIYAO PHARMACEUTICALS CO LTDInactiveFLUOXETINE HYDROCHLORIDE

DMF 199802006

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

11 letters from Drugs@FDA

Date	Submission	Document
Sep 23, 2021	SUPPL -15	View Letter (PDF)
Jan 11, 2017	SUPPL -11	View Letter (PDF)
Dec 2, 2014	SUPPL -10	View Letter (PDF)
Jul 8, 2013	SUPPL -7	View Letter (PDF)
Jul 8, 2013	SUPPL -8	View Letter (PDF)
Jul 8, 2013	SUPPL -9	View Letter (PDF)
Jul 8, 2013	SUPPL -6	View Letter (PDF)
Apr 27, 2009	SUPPL -5	View Letter (PDF)
Dec 3, 2007	SUPPL -2	View Letter (PDF)
Apr 9, 2007	SUPPL -1	View Letter (PDF)
May 22, 2006	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: May 19, 2006

No patent or exclusivity listings for this strength.

#002 — EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: May 19, 2006

#003 — EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: May 19, 2006