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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078406
Company: AUROBINDO PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 10MG BASE TABLET;ORAL Prescription AB No No
PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 20MG BASE TABLET;ORAL Prescription AB No No
PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 30MG BASE TABLET;ORAL Prescription AB No No
PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 40MG BASE TABLET;ORAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/25/2007 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/19/2022 SUPPL-32 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

01/19/2022 SUPPL-31 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

03/19/2020 SUPPL-27 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

03/19/2020 SUPPL-25 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

09/24/2014 SUPPL-23 Labeling-Package Insert

Label is not available on this site.

12/31/2013 SUPPL-21 Labeling-Package Insert

Label is not available on this site.

07/31/2012 SUPPL-17 Labeling-Package Insert

Label is not available on this site.

03/04/2011 SUPPL-15 Labeling-Package Insert

Label is not available on this site.

12/10/2010 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

05/06/2009 SUPPL-9 Labeling

Label is not available on this site.

05/06/2009 SUPPL-6 Labeling

Label is not available on this site.

06/15/2009 SUPPL-3 Labeling

Label is not available on this site.

02/06/2008 SUPPL-1 Labeling

Label is not available on this site.

PAROXETINE HYDROCHLORIDE

TABLET;ORAL; EQ 10MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PAROXETINE PAROXETINE HYDROCHLORIDE EQ 10MG BASE TABLET;ORAL Prescription No AB 203854 PRINSTON INC
PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 10MG BASE TABLET;ORAL Prescription No AB 075356 APOTEX
PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 10MG BASE TABLET;ORAL Prescription No AB 078406 AUROBINDO PHARMA
PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 10MG BASE TABLET;ORAL Prescription No AB 076618 CHARTWELL RX
PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 10MG BASE TABLET;ORAL Prescription No AB 078902 MYLAN
PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 10MG BASE TABLET;ORAL Prescription No AB 076968 OXFORD PHARMS
PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 10MG BASE TABLET;ORAL Prescription No AB 211248 YILING
PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 10MG BASE TABLET;ORAL Prescription No AB 077584 ZYDUS PHARMS USA
PAXIL PAROXETINE HYDROCHLORIDE EQ 10MG BASE TABLET;ORAL Prescription Yes AB 020031 APOTEX

TABLET;ORAL; EQ 20MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PAROXETINE PAROXETINE HYDROCHLORIDE EQ 20MG BASE TABLET;ORAL Prescription No AB 203854 PRINSTON INC
PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 20MG BASE TABLET;ORAL Prescription No AB 075356 APOTEX
PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 20MG BASE TABLET;ORAL Prescription No AB 078406 AUROBINDO PHARMA
PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 20MG BASE TABLET;ORAL Prescription No AB 076618 CHARTWELL RX
PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 20MG BASE TABLET;ORAL Prescription No AB 078902 MYLAN
PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 20MG BASE TABLET;ORAL Prescription No AB 076968 OXFORD PHARMS
PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 20MG BASE TABLET;ORAL Prescription No AB 211248 YILING
PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 20MG BASE TABLET;ORAL Prescription No AB 077584 ZYDUS PHARMS USA
PAXIL PAROXETINE HYDROCHLORIDE EQ 20MG BASE TABLET;ORAL Prescription Yes AB 020031 APOTEX

TABLET;ORAL; EQ 30MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PAROXETINE PAROXETINE HYDROCHLORIDE EQ 30MG BASE TABLET;ORAL Prescription No AB 203854 PRINSTON INC
PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 30MG BASE TABLET;ORAL Prescription No AB 075356 APOTEX
PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 30MG BASE TABLET;ORAL Prescription No AB 078406 AUROBINDO PHARMA
PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 30MG BASE TABLET;ORAL Prescription No AB 076618 CHARTWELL RX
PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 30MG BASE TABLET;ORAL Prescription No AB 078902 MYLAN
PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 30MG BASE TABLET;ORAL Prescription No AB 076968 OXFORD PHARMS
PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 30MG BASE TABLET;ORAL Prescription No AB 211248 YILING
PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 30MG BASE TABLET;ORAL Prescription No AB 077584 ZYDUS PHARMS USA
PAXIL PAROXETINE HYDROCHLORIDE EQ 30MG BASE TABLET;ORAL Prescription Yes AB 020031 APOTEX

TABLET;ORAL; EQ 40MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PAROXETINE PAROXETINE HYDROCHLORIDE EQ 40MG BASE TABLET;ORAL Prescription No AB 203854 PRINSTON INC
PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 40MG BASE TABLET;ORAL Prescription No AB 075356 APOTEX
PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 40MG BASE TABLET;ORAL Prescription No AB 078406 AUROBINDO PHARMA
PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 40MG BASE TABLET;ORAL Prescription No AB 076618 CHARTWELL RX
PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 40MG BASE TABLET;ORAL Prescription No AB 078902 MYLAN
PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 40MG BASE TABLET;ORAL Prescription No AB 076968 OXFORD PHARMS
PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 40MG BASE TABLET;ORAL Prescription No AB 211248 YILING
PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 40MG BASE TABLET;ORAL Prescription No AB 077584 ZYDUS PHARMS USA
PAXIL PAROXETINE HYDROCHLORIDE EQ 40MG BASE TABLET;ORAL Prescription Yes AB 020031 APOTEX
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