APPLICATION
ANDA074421
TYPE
ANDA
ORIGINAL APPROVAL
1995-09-29
LATEST ACTION
2013-04-11
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
CYCLOBENZAPRINE HYDROCHLORIDEDiscontinued
CYCLOBENZAPRINE HYDROCHLORIDE 10MG · TABLET · ORAL
Approval history
2013-04-11Labeling · Supplement 33 · standardAP
2013-04-02Manufacturing (CMC) · Supplement 32 · unknownAP
2010-03-16Labeling · Supplement 21AP
2001-05-29Manufacturing (CMC) · Supplement 5AP
2001-03-16Manufacturing (CMC) · Supplement 4AP
2000-11-20Manufacturing (CMC) · Supplement 3AP
2000-07-07Manufacturing (CMC) · Supplement 2AP
1996-07-01Manufacturing (CMC) · Supplement 1AP
1995-09-29OriginalAP
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.
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