Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021777

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AMRIX (CYCLOBENZAPRINE HYDROCHLORIDE)
15MG
Marketing Status: Prescription

Active Ingredient: CYCLOBENZAPRINE HYDROCHLORIDE
Proprietary Name: AMRIX
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 15MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021777
Product Number: 001
Approval Date: Feb 1, 2007
Applicant Holder Full Name: TEVA PHARMACEUTICALS INTERNATIONAL GMBH
Marketing Status:  Prescription
Patent and Exclusivity Information

AMRIX (CYCLOBENZAPRINE HYDROCHLORIDE)
30MG
Marketing Status: Prescription

Active Ingredient: CYCLOBENZAPRINE HYDROCHLORIDE
Proprietary Name: AMRIX
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 30MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N021777
Product Number: 002
Approval Date: Feb 1, 2007
Applicant Holder Full Name: TEVA PHARMACEUTICALS INTERNATIONAL GMBH
Marketing Status:  Prescription
Patent and Exclusivity Information