Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 073137
Company: SUN PHARM INDUSTRIES
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
TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 50MG TABLET;ORAL Prescription AB No No
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
03/24/1993 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
07/17/2014 SUPPL-34 Labeling-Package Insert

Label is not available on this site.

06/25/2014 SUPPL-33 Labeling-Package Insert

Label is not available on this site.

07/30/2013 SUPPL-32 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

11/13/2007 SUPPL-28 Labeling

Label is not available on this site.

11/13/2007 SUPPL-27 Labeling

Label is not available on this site.

06/25/2007 SUPPL-26 Labeling

Label is not available on this site.

08/26/2005 SUPPL-22 Labeling

Label is not available on this site.

05/05/2005 SUPPL-21 Labeling

Label is not available on this site.

05/07/2003 SUPPL-15 Labeling

Label is not available on this site.

02/14/2002 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

03/13/2001 SUPPL-11 Labeling

Label is not available on this site.

05/16/2000 SUPPL-10 Manufacturing (CMC)-Facility

Label is not available on this site.

05/16/2000 SUPPL-9 Manufacturing (CMC)-Facility

Label is not available on this site.

04/27/1998 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

04/27/1998 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

04/27/1998 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

12/05/1997 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

02/04/1998 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

02/24/1997 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

06/22/1995 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

01/12/1994 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

TABLET;ORAL; 50MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 206923 ACCORD HLTHCARE
TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 071636 ALVOGEN
TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 071258 APOTEX
TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 072192 OXFORD PHARMS
TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 073137 SUN PHARM INDUSTRIES
TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 071523 TEVA PHARMS USA
TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 202180 TORRENT
TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 205253 ZYDUS PHARMS

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 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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