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FDA NDA · NDA021777

CYCLOBENZAPRINE HYDROCHLORIDE

Sponsor: TEVA PHARMS INTL

APPLICATION
NDA021777
TYPE
NDA
ORIGINAL APPROVAL
2007-02-01
LATEST ACTION
2024-04-25
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

AMRIX · ReferencePrescription
CYCLOBENZAPRINE HYDROCHLORIDE 15MG · CAPSULE, EXTENDED RELEASE · ORAL
AMRIX · ReferencePrescription
CYCLOBENZAPRINE HYDROCHLORIDE 30MG · CAPSULE, EXTENDED RELEASE · ORAL

Approval history

2024-04-25Labeling · Supplement 19 · standard — Letter ↗AP
2019-04-23Labeling · Supplement 17 · standard — Label ↗AP
2016-05-25Labeling · Supplement 14 · standard — Letter ↗AP
2016-03-24Manufacturing (CMC) · Supplement 13 · standardAP
2013-06-07Labeling · Supplement 9 · standard — Label ↗AP
2013-06-07Labeling · Supplement 6 · standard — Letter ↗AP
2013-04-11Labeling · Supplement 12 · unknown — Letter ↗AP
2008-03-24Labeling · Supplement 3 · standard — Letter ↗AP
2007-02-01Type 3 - New Dosage Form · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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