Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 071636
Company: ALVOGEN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 50MG 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
04/18/1988 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
07/17/2014 SUPPL-29 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

08/15/2005 SUPPL-23 Labeling

Label is not available on this site.

01/06/2005 SUPPL-21 Labeling

Label is not available on this site.

10/31/2002 SUPPL-16 Labeling

Label is not available on this site.

11/02/2001 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

10/18/2000 SUPPL-14 Labeling

Label is not available on this site.

09/12/2000 SUPPL-13 Labeling

Label is not available on this site.

09/12/2000 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

09/12/2000 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

09/12/2000 SUPPL-10 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/12/2000 SUPPL-9 Manufacturing (CMC)-Formulation

Label is not available on this site.

11/22/1995 SUPPL-7 Labeling

Label is not available on this site.

01/18/1996 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

04/10/1995 SUPPL-5 Labeling

Label is not available on this site.

04/28/1994 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

12/30/1991 SUPPL-3 Labeling

Label is not available on this site.

10/22/1991 SUPPL-2 Labeling

Label is not available on this site.

09/30/1991 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

TRAZODONE HYDROCHLORIDE

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

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