Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 077873
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 12.5MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 25MG BASE TABLET, EXTENDED RELEASE;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
06/29/2007 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077873s000_ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2007/077873Orig1s000.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/15/2015 SUPPL-21 Labeling-Package Insert

Label is not available on this site.

12/27/2013 SUPPL-20 Labeling-Container/Carton Labels

Label is not available on this site.

12/27/2011 SUPPL-19 Labeling-Package Insert

Label is not available on this site.

06/24/2011 SUPPL-17 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

07/27/2011 SUPPL-15 Labeling-Package Insert

Label is not available on this site.

08/18/2010 SUPPL-14 Labeling-Package Insert, Labeling-Medication Guide, Labeling-Container/Carton Labels

Label is not available on this site.

07/02/2010 SUPPL-11 Labeling-Container/Carton Labels, Labeling-Medication Guide

Label is not available on this site.

07/22/2009 SUPPL-5 Labeling

Label is not available on this site.

11/17/2008 SUPPL-3 Labeling

Label is not available on this site.

03/26/2008 SUPPL-2 Labeling

Label is not available on this site.

PAROXETINE HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL; EQ 12.5MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 12.5MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204744 LANNETT CO INC
PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 12.5MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204134 LUPIN LTD
PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 12.5MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 077873 MYLAN
PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 12.5MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 209293 SCIECURE PHARMA INC
PAXIL CR PAROXETINE HYDROCHLORIDE EQ 12.5MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 020936 APOTEX TECHNOLOGIES

TABLET, EXTENDED RELEASE;ORAL; EQ 25MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 25MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204744 LANNETT CO INC
PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 25MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204134 LUPIN LTD
PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 25MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 077873 MYLAN
PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 25MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 209293 SCIECURE PHARMA INC
PAXIL CR PAROXETINE HYDROCHLORIDE EQ 25MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 020936 APOTEX TECHNOLOGIES

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