Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078626
Company: MYLAN PHARMS 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 Discontinued 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
01/31/2008 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
01/05/2016 SUPPL-9 Labeling-Medication Guide, Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

06/02/2014 SUPPL-5 Labeling-Container/Carton Labels

Label is not available on this site.

04/26/2012 SUPPL-3 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

07/29/2014 SUPPL-2 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

08/31/2009 SUPPL-1 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 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
SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET;ORAL Prescription No AB 077106 ZYDUS PHARMS USA
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 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
SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET;ORAL Prescription No AB 077106 ZYDUS PHARMS USA
ZOLOFT SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET;ORAL Prescription Yes AB 019839 PFIZER

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