Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075356
Company: APOTEX
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
07/30/2003 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/75356ap.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/21/2020 SUPPL-37 Labeling-Package Insert

Label is not available on this site.

12/21/2014 SUPPL-36 Labeling-Package Insert

Label is not available on this site.

12/31/2013 SUPPL-35 Labeling-Package Insert

Label is not available on this site.

12/15/2011 SUPPL-34 Labeling-Package Insert

Label is not available on this site.

01/05/2012 SUPPL-33 Labeling-Package Insert

Label is not available on this site.

07/27/2011 SUPPL-32 Labeling-Package Insert

Label is not available on this site.

03/25/2010 SUPPL-31 Labeling-Package Insert

Label is not available on this site.

10/26/2009 SUPPL-30 Labeling

Label is not available on this site.

05/14/2009 SUPPL-29 Labeling

Label is not available on this site.

02/05/2008 SUPPL-25 Labeling

Label is not available on this site.

02/05/2008 SUPPL-24 Labeling

Label is not available on this site.

02/05/2007 SUPPL-23 Labeling

Label is not available on this site.

02/05/2007 SUPPL-21 Labeling

Label is not available on this site.

06/29/2006 SUPPL-19 Labeling

Label is not available on this site.

06/29/2006 SUPPL-18 Labeling

Label is not available on this site.

12/27/2005 SUPPL-16 Labeling

Label is not available on this site.

12/02/2005 SUPPL-15 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 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 076618 TEVA
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 TECHNOLOGIES

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 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 076618 TEVA
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 TECHNOLOGIES

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 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 076618 TEVA
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 TECHNOLOGIES

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 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 076618 TEVA
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 TECHNOLOGIES

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