Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 071524
Company: TEVA PHARMS USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 100MG 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
12/11/1987 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
07/18/2014 SUPPL-51 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

07/11/2014 SUPPL-50 Labeling-Package Insert

Label is not available on this site.

07/01/2014 SUPPL-49 Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

07/08/2009 SUPPL-38 Labeling

Label is not available on this site.

08/13/2008 SUPPL-35 Labeling

Label is not available on this site.

06/25/2007 SUPPL-33 Labeling

Label is not available on this site.

11/29/2005 SUPPL-23 Labeling

Label is not available on this site.

07/08/2005 SUPPL-22 Labeling

Label is not available on this site.

11/12/2002 SUPPL-19 Labeling

Label is not available on this site.

03/30/2001 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

10/25/2000 SUPPL-13 Labeling

Label is not available on this site.

07/07/2000 SUPPL-12 Manufacturing (CMC)-Facility

Label is not available on this site.

03/22/1999 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

03/22/1999 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

10/04/1996 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

04/22/1996 SUPPL-6 Labeling

Label is not available on this site.

05/11/1994 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

04/30/1992 SUPPL-4 Labeling

Label is not available on this site.

12/16/1991 SUPPL-3 Labeling

Label is not available on this site.

09/20/1988 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

TRAZODONE HYDROCHLORIDE

TABLET;ORAL; 100MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AB 206923 ACCORD HLTHCARE
TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AB 071514 ALVOGEN
TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AB 071196 APOTEX INC
TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AB 072193 OXFORD PHARMS
TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AB 073137 SUN PHARM INDUSTRIES
TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AB 071524 TEVA PHARMS USA
TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AB 202180 TORRENT
TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AB 205253 ZYDUS PHARMS

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