Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 072484
Company: AUROLIFE PHARMA LLC
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
04/30/1990 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-14 Labeling-Package Insert

Label is not available on this site.

05/09/2001 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

09/17/2001 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

08/30/2000 SUPPL-9 Labeling

Label is not available on this site.

09/10/1999 SUPPL-8 Labeling

Label is not available on this site.

05/05/1999 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

09/10/1999 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

04/25/1997 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

05/03/1996 SUPPL-4 Labeling

Label is not available on this site.

04/26/1995 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

05/21/1992 SUPPL-2 Labeling

Label is not available on this site.

12/09/1991 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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