APPLICATION
ANDA206703
TYPE
ANDA
ORIGINAL APPROVAL
2018-07-24
LATEST ACTION
2019-12-13
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
CYCLOBENZAPRINE HYDROCHLORIDEDiscontinued
CYCLOBENZAPRINE HYDROCHLORIDE 15MG · CAPSULE, EXTENDED RELEASE · ORAL
CYCLOBENZAPRINE HYDROCHLORIDEDiscontinued
CYCLOBENZAPRINE HYDROCHLORIDE 30MG · CAPSULE, EXTENDED RELEASE · ORAL
Approval history
2019-12-13Labeling · Supplement 1 · standardAP
2018-07-24UNKNOWN · Original · standardAP
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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