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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076442
Company: SCIEGEN 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 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
04/30/2007 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
08/31/2009 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 076881 ACI
SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET;ORAL Prescription No AB 214790 ASCENT PHARMS 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 078403 GRANULES
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 078677 REYOUNG
SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET;ORAL Prescription No AB 076442 SCIEGEN PHARMS INC
SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET;ORAL Prescription No AB 076882 VIWIT PHARM
ZOLOFT SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET;ORAL Prescription Yes AB 019839 VIATRIS

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 076881 ACI
SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET;ORAL Prescription No AB 214790 ASCENT PHARMS 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 078403 GRANULES
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 078677 REYOUNG
SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET;ORAL Prescription No AB 076442 SCIEGEN PHARMS INC
SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET;ORAL Prescription No AB 076882 VIWIT PHARM
ZOLOFT SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET;ORAL Prescription Yes AB 019839 VIATRIS

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 076881 ACI
SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET;ORAL Prescription No AB 214790 ASCENT PHARMS 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 078403 GRANULES
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 078677 REYOUNG
SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET;ORAL Prescription No AB 076442 SCIEGEN PHARMS INC
SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET;ORAL Prescription No AB 076882 VIWIT PHARM
ZOLOFT SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET;ORAL Prescription Yes AB 019839 VIATRIS
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