Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 074421
Company: PLIVA

Products on ANDA 074421

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074421

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.