← FDA Drug Approvals (Drugs@FDA)
AMRIX
NDA · New Drug Application · Sponsor: TEVA PHARMS INTL · Approved 2007-02-01
Drug application
- FDA Application #
NDA021777- Application type
- New Drug Application
- Brand name
- AMRIX
- Generic name
- CYCLOBENZAPRINE HYDROCHLORIDE
- Active ingredients
- CYCLOBENZAPRINE HYDROCHLORIDE
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- TEVA PHARMS INTL
- Manufacturer
- Amneal Pharmaceuticals of New York LLC
- First approval
- 2007-02-01
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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