Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 070857
Company: WATSON LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 50MG TABLET;ORAL Discontinued None 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
10/10/1986 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-46 Labeling-Package Insert

Label is not available on this site.

11/13/2007 SUPPL-40 Labeling

Label is not available on this site.

07/09/2007 SUPPL-38 Labeling

Label is not available on this site.

04/24/2007 SUPPL-37 Labeling

Label is not available on this site.

08/30/2005 SUPPL-30 Labeling

Label is not available on this site.

01/06/2005 SUPPL-27 Labeling

Label is not available on this site.

05/22/2001 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

04/25/2001 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

02/20/2001 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

04/11/2001 SUPPL-20 Manufacturing (CMC)-Facility

Label is not available on this site.

08/01/2000 SUPPL-19 Labeling

Label is not available on this site.

11/28/2000 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

07/21/2000 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

07/21/2000 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

07/21/2000 SUPPL-15 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

05/12/2000 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

09/20/1999 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

09/16/1992 SUPPL-10 Labeling

Label is not available on this site.

01/28/1991 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

08/07/1991 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

06/29/1990 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

11/01/1988 SUPPL-6 Bioequivalence

Label is not available on this site.

11/07/1988 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

04/12/1988 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

07/24/1987 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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