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FDA ANDA · ANDA073144

CYCLOBENZAPRINE HYDROCHLORIDE

Sponsor: RISING

APPLICATION
ANDA073144
TYPE
ANDA
ORIGINAL APPROVAL
1991-05-31
LATEST ACTION
2013-04-11
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

CYCLOBENZAPRINE HYDROCHLORIDEDiscontinued
CYCLOBENZAPRINE HYDROCHLORIDE 7.5MG · TABLET · ORAL
CYCLOBENZAPRINE HYDROCHLORIDEDiscontinued
CYCLOBENZAPRINE HYDROCHLORIDE 10MG · TABLET · ORAL
CYCLOBENZAPRINE HYDROCHLORIDEDiscontinued
CYCLOBENZAPRINE HYDROCHLORIDE 5MG · TABLET · ORAL

Approval history

2013-04-11Labeling · Supplement 25 · standardAP
2006-02-03Labeling · Supplement 10AP
2005-07-22Manufacturing (CMC) · Supplement 15AP
2005-07-22Manufacturing (CMC) · Supplement 13AP
2005-07-22Manufacturing (CMC) · Supplement 11AP
2005-07-22Manufacturing (CMC) · Supplement 14AP
2005-07-22Supplement · Supplement 9AP
2005-07-22Manufacturing (CMC) · Supplement 12AP
2001-06-28Manufacturing (CMC) · Supplement 8AP
1998-02-05Manufacturing (CMC) · Supplement 7AP
1996-11-06Manufacturing (CMC) · Supplement 6AP
1996-05-31Manufacturing (CMC) · Supplement 5AP
1993-09-07Labeling · Supplement 2AP
1993-09-07Manufacturing (CMC) · Supplement 3AP
1993-09-07Manufacturing (CMC) · Supplement 1AP
1991-05-31OriginalAP
VIEW ON DRUGS@FDA ↗

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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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