Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 071068
Company: HERITAGE PHARMA
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
11/25/1986 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
12/16/2016 SUPPL-15 Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

10/01/1993 SUPPL-13 Labeling

Label is not available on this site.

11/19/1990 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

04/26/1989 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

04/26/1989 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

04/26/1989 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

12/06/1988 SUPPL-6 Labeling

Label is not available on this site.

08/18/1988 SUPPL-5 Labeling

Label is not available on this site.

07/30/1987 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

07/30/1987 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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