APPLICATION
ANDA073143
TYPE
ANDA
ORIGINAL APPROVAL
1991-11-27
LATEST ACTION
2002-11-08
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
CYCLOBENZAPRINE HYDROCHLORIDEDiscontinued
CYCLOBENZAPRINE HYDROCHLORIDE 10MG · TABLET · ORAL
Approval history
2002-11-08Manufacturing (CMC) · Supplement 7AP
2002-11-07Manufacturing (CMC) · Supplement 6AP
2002-08-23Manufacturing (CMC) · Supplement 5AP
2001-09-05Manufacturing (CMC) · Supplement 4AP
1999-11-10Manufacturing (CMC) · Supplement 3AP
1992-10-06Labeling · Supplement 2AP
1992-09-23Manufacturing (CMC) · Supplement 1AP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.