← FDA DRUG APPROVALS

FDA ANDA · ANDA078048

CYCLOBENZAPRINE HYDROCHLORIDE

Sponsor: KVK TECH

APPLICATION
ANDA078048
TYPE
ANDA
ORIGINAL APPROVAL
2011-02-28
LATEST ACTION
2013-04-11
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

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

Approval history

2013-04-11Labeling · Supplement 2 · standardAP
2011-02-28OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →