Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 077977
Company: SUN PHARM INDS LTD
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
SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE EQ 150MG BASE TABLET;ORAL Prescription None No No
SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE EQ 200MG BASE TABLET;ORAL Prescription None 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
12/23/2015 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

01/20/2015 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

12/12/2014 SUPPL-10 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

12/12/2014 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

09/29/2011 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

09/30/2009 SUPPL-7 Labeling

Label is not available on this site.

03/23/2009 SUPPL-6 Labeling

Label is not available on this site.

03/23/2009 SUPPL-4 Labeling

Label is not available on this site.

09/15/2008 SUPPL-3 Labeling

Label is not available on this site.

01/09/2008 SUPPL-2 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 077106 CADILA
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 078626 MYLAN PHARMS INC
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 076465 TEVA
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 077106 CADILA
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 078626 MYLAN PHARMS INC
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 076465 TEVA
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 077106 CADILA
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 076465 TEVA
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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