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FDA ANDA · ANDA071611

CYCLOBENZAPRINE HYDROCHLORIDE

Sponsor: ACTAVIS LABS FL INC

APPLICATION
ANDA071611
TYPE
ANDA
ORIGINAL APPROVAL
1988-02-29
LATEST ACTION
2013-07-30
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

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

Approval history

2013-07-30Labeling · Supplement 70 · standardAP
2013-04-11Labeling · Supplement 69 · standardAP
2012-09-24Manufacturing (CMC) · Supplement 67AP
2006-02-03Manufacturing (CMC) · Supplement 38AP
2006-02-03Manufacturing (CMC) · Supplement 40AP
2006-02-03Labeling · Supplement 39AP
2001-04-25Manufacturing (CMC) · Supplement 34AP
2000-12-29Manufacturing (CMC) · Supplement 33AP
1998-12-23Manufacturing (CMC) · Supplement 30AP
1996-08-15Manufacturing (CMC) · Supplement 29AP
1996-08-15Manufacturing (CMC) · Supplement 27AP
1996-08-15Manufacturing (CMC) · Supplement 25AP
1996-08-15Manufacturing (CMC) · Supplement 28AP
1996-08-15Manufacturing (CMC) · Supplement 26AP
1996-08-15Manufacturing (CMC) · Supplement 24AP
1993-12-20Manufacturing (CMC) · Supplement 23AP
1993-06-29Labeling · Supplement 22AP
1993-03-12Manufacturing (CMC) · Supplement 17AP
1993-03-12Labeling · Supplement 18AP
1992-09-29Manufacturing (CMC) · Supplement 15AP
1992-09-29Manufacturing (CMC) · Supplement 16AP
1992-09-29Manufacturing (CMC) · Supplement 14AP
1991-05-31Manufacturing (CMC) · Supplement 11AP
1991-02-23Manufacturing (CMC) · Supplement 7AP
1991-02-23Manufacturing (CMC) · Supplement 5AP
1991-02-23Manufacturing (CMC) · Supplement 3AP
1991-02-23Manufacturing (CMC) · Supplement 13AP
1991-02-23Manufacturing (CMC) · Supplement 8AP
1991-02-23Manufacturing (CMC) · Supplement 4AP
1991-02-23Manufacturing (CMC) · Supplement 2AP
1991-01-28Manufacturing (CMC) · Supplement 12AP
1990-02-22Manufacturing (CMC) · Supplement 10AP
1989-04-20Manufacturing (CMC) · Supplement 1AP
1988-02-29OriginalAP
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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