Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076882
Company: APOTEX INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET;ORAL Prescription AB No No
SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET;ORAL Prescription AB No No
SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE EQ 100MG 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
02/06/2007 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
06/04/2015 SUPPL-16 Labeling-Package Insert

Label is not available on this site.

10/27/2014 SUPPL-15 Labeling-Package Insert

Label is not available on this site.

10/27/2014 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

10/27/2014 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

07/31/2012 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

01/04/2011 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

08/08/2008 SUPPL-9 Labeling

Label is not available on this site.

08/08/2008 SUPPL-6 Labeling

Label is not available on this site.

05/06/2008 SUPPL-3 Labeling

Label is not available on this site.

SERTRALINE HYDROCHLORIDE

TABLET;ORAL; EQ 25MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET;ORAL Prescription No AB 202825 ACCORD HLTHCARE
SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET;ORAL Prescription No AB 076882 APOTEX INC
SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET;ORAL Prescription No AB 077206 AUROBINDO PHARMA
SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET;ORAL Prescription No AB 078677 AUSTARPHARMA LLC
SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET;ORAL Prescription No AB 076465 HERITAGE PHARMA
SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET;ORAL Prescription No AB 077397 INVAGEN PHARMS
SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET;ORAL Prescription No AB 077670 LUPIN
SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET;ORAL Prescription No AB 078175 OXFORD PHARMS
SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET;ORAL Prescription No AB 077977 SUN PHARM INDS LTD
SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET;ORAL Prescription No AB 077765 TORRENT PHARMS
SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET;ORAL Prescription No AB 078403 WOCKHARDT
ZOLOFT SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET;ORAL Prescription Yes AB 019839 PFIZER

TABLET;ORAL; EQ 50MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET;ORAL Prescription No AB 202825 ACCORD HLTHCARE
SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET;ORAL Prescription No AB 076882 APOTEX INC
SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET;ORAL Prescription No AB 077206 AUROBINDO PHARMA
SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET;ORAL Prescription No AB 078677 AUSTARPHARMA LLC
SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET;ORAL Prescription No AB 076465 HERITAGE PHARMA
SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET;ORAL Prescription No AB 077397 INVAGEN PHARMS
SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET;ORAL Prescription No AB 077670 LUPIN
SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET;ORAL Prescription No AB 078175 OXFORD PHARMS
SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET;ORAL Prescription No AB 077977 SUN PHARM INDS LTD
SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET;ORAL Prescription No AB 077765 TORRENT PHARMS
SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET;ORAL Prescription No AB 078403 WOCKHARDT
ZOLOFT SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET;ORAL Prescription Yes AB 019839 PFIZER

TABLET;ORAL; EQ 100MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET;ORAL Prescription No AB 202825 ACCORD HLTHCARE
SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET;ORAL Prescription No AB 076882 APOTEX INC
SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET;ORAL Prescription No AB 077206 AUROBINDO PHARMA
SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET;ORAL Prescription No AB 078677 AUSTARPHARMA LLC
SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET;ORAL Prescription No AB 076465 HERITAGE PHARMA
SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET;ORAL Prescription No AB 077397 INVAGEN PHARMS
SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET;ORAL Prescription No AB 077670 LUPIN
SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET;ORAL Prescription No AB 078175 OXFORD PHARMS
SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET;ORAL Prescription No AB 077977 SUN PHARM INDS LTD
SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET;ORAL Prescription No AB 077765 TORRENT PHARMS
SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET;ORAL Prescription No AB 078403 WOCKHARDT
ZOLOFT SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET;ORAL Prescription Yes AB 019839 PFIZER

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