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FLUOXETINE HYDROCHLORIDE

ANDA

FLUOXETINE HYDROCHLORIDE | A078619 | AUROBINDO PHARMA LTD

3 strengths0 unique patents0 unique exclusivities

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.

Products (3)

Sort:

#001 — EQ 10MG BASE

AB1

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Jan 31, 2008

No patent or exclusivity listings for this strength.

#002 — EQ 20MG BASE

AB1

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Jan 31, 2008

#003 — EQ 40MG BASE

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Jan 31, 2008

Change History (1)

Recent changes detected for this application.

MODIFIEDrs7/1/2026

Aurobindo Pharma's Fluoxetine Hydrochloride (NDA 078619, supplement 003) now carries a Risk Evaluation and Mitigation Strategy (REMS) requirement.

Old: No

New: Yes