Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 070444
Company: PAR PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FLURAZEPAM HYDROCHLORIDE FLURAZEPAM HYDROCHLORIDE 15MG 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
03/20/1986 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
01/17/2017 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

07/21/1993 SUPPL-11 Labeling

Label is not available on this site.

08/09/1989 SUPPL-10 Labeling

Label is not available on this site.

07/20/1989 SUPPL-9 Bioequivalence

Label is not available on this site.

08/15/1995 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

02/03/1988 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

05/05/1986 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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