Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074421
Company: PLIVA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 10MG 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
09/29/1995 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
04/11/2013 SUPPL-33 Labeling-Package Insert

Label is not available on this site.

04/02/2013 SUPPL-32 Labeling-Package Insert

Label is not available on this site.

03/16/2010 SUPPL-21 Labeling

Label is not available on this site.

05/29/2001 SUPPL-5 Manufacturing (CMC)-Facility

Label is not available on this site.

03/16/2001 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

11/20/2000 SUPPL-3 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

07/07/2000 SUPPL-2 Manufacturing (CMC)-Facility

Label is not available on this site.

07/01/1996 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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