Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078902
Company: MYLAN
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
03/13/2008 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
07/02/2015 SUPPL-15 Labeling-Package Insert

Label is not available on this site.

12/31/2013 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

12/27/2011 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

07/27/2011 SUPPL-10 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

05/12/2011 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

03/25/2010 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

10/15/2009 SUPPL-5 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 205528 JUBILANT GENERICS
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 078194 SUN PHARM INDS INC
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 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 205528 JUBILANT GENERICS
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 078194 SUN PHARM INDS INC
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 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 205528 JUBILANT GENERICS
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 078194 SUN PHARM INDS INC
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 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 205528 JUBILANT GENERICS
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 078194 SUN PHARM INDS INC
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 077584 ZYDUS PHARMS USA
PAXIL PAROXETINE HYDROCHLORIDE EQ 40MG BASE TABLET;ORAL Prescription Yes AB 020031 APOTEX TECHNOLOGIES

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