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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 071525
Company: PLIVA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 150MG 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
03/09/1988 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
11/09/2022 SUPPL-72 Labeling-Medication Guide, Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.
11/09/2022 SUPPL-63 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
07/18/2014 SUPPL-55 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
07/11/2014 SUPPL-54 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
07/01/2014 SUPPL-53 Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
07/08/2009 SUPPL-43 Labeling

Label is not available on this site.
08/13/2008 SUPPL-40 Labeling

Label is not available on this site.
06/25/2007 SUPPL-37 Labeling

Label is not available on this site.
11/29/2005 SUPPL-27 Labeling

Label is not available on this site.
07/08/2005 SUPPL-26 Labeling

Label is not available on this site.
11/12/2002 SUPPL-23 Labeling

Label is not available on this site.
03/30/2001 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.
10/25/2000 SUPPL-17 Labeling

Label is not available on this site.
07/07/2000 SUPPL-16 Manufacturing (CMC)-Facility

Label is not available on this site.
03/22/1999 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.
03/22/1999 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.
10/04/1996 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.
04/22/1996 SUPPL-11 Labeling

Label is not available on this site.
04/21/1995 SUPPL-10 Labeling

Label is not available on this site.
01/11/1994 SUPPL-9 Labeling

Label is not available on this site.
05/11/1994 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.
05/18/1993 SUPPL-7 Labeling

Label is not available on this site.
04/30/1992 SUPPL-6 Labeling

Label is not available on this site.
12/16/1991 SUPPL-5 Labeling

Label is not available on this site.
09/20/1988 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.
05/26/1988 SUPPL-2 Labeling

Label is not available on this site.
05/26/1988 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

TRAZODONE HYDROCHLORIDE

TABLET;ORAL; 150MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 150MG TABLET;ORAL Prescription No AB 206923 ACCORD HLTHCARE
TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 150MG TABLET;ORAL Prescription No AB 071196 APOTEX INC
TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 150MG TABLET;ORAL Prescription No AB 204852 AUROBINDO PHARMA
TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 150MG TABLET;ORAL Prescription No AB 071525 PLIVA
TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 150MG TABLET;ORAL Prescription No AB 073137 SUN PHARM INDUSTRIES
TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 150MG TABLET;ORAL Prescription No AB 202180 TORRENT
TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 150MG TABLET;ORAL Prescription No AB 205253 ZYDUS PHARMS
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