Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 071108
Company: HIKMA PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FLURAZEPAM HYDROCHLORIDE FLURAZEPAM HYDROCHLORIDE 30MG CAPSULE;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
12/08/1986 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
02/22/2019 SUPPL-29 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

11/18/2016 SUPPL-28 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

12/16/2016 SUPPL-27 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

08/11/2009 SUPPL-26 Labeling

Label is not available on this site.

08/20/2008 SUPPL-25 Labeling

Label is not available on this site.

11/30/2000 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

10/07/1999 SUPPL-22 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/01/1998 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

05/06/1994 SUPPL-20 Labeling

Label is not available on this site.

01/31/1991 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

03/06/1989 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

03/06/1989 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

03/06/1989 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

08/01/1988 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

07/12/1988 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

04/28/1988 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

04/28/1988 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

03/22/1988 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

03/22/1988 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

03/22/1988 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

03/22/1988 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

08/12/1987 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

08/12/1987 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

10/21/1988 SUPPL-3 Labeling

Label is not available on this site.

10/21/1988 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

10/21/1988 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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