Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 070345
Company: MYLAN PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FLURAZEPAM HYDROCHLORIDE FLURAZEPAM HYDROCHLORIDE 30MG CAPSULE;ORAL Prescription None No Yes
FLURAZEPAM HYDROCHLORIDE FLURAZEPAM HYDROCHLORIDE 15MG CAPSULE;ORAL Prescription 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
06/12/1985 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
02/06/2019 SUPPL-20 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

12/16/2016 SUPPL-18 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

01/15/2015 SUPPL-17 Labeling-Package Insert

Label is not available on this site.

09/28/2010 SUPPL-16 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

09/18/2002 SUPPL-11 Labeling

Label is not available on this site.

02/25/1998 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

02/05/1998 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

10/19/1993 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

04/29/1993 SUPPL-6 Labeling

Label is not available on this site.

01/31/1990 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

06/16/1989 SUPPL-4 Labeling

Label is not available on this site.

02/18/1988 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

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