Details for New Drug Application (NDA): 078643
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The generic ingredient in CYCLOBENZAPRINE HYDROCHLORIDE is cyclobenzaprine hydrochloride. There are sixteen drug master file entries for this compound. Fifty-five suppliers are listed for this compound. Additional details are available on the cyclobenzaprine hydrochloride profile page.
Summary for 078643
Tradename: | CYCLOBENZAPRINE HYDROCHLORIDE |
Applicant: | Aurobindo Pharma |
Ingredient: | cyclobenzaprine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 078643
Physiological Effect | Centrally-mediated Muscle Relaxation |
Suppliers and Packaging for NDA: 078643
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CYCLOBENZAPRINE HYDROCHLORIDE | cyclobenzaprine hydrochloride | TABLET;ORAL | 078643 | ANDA | Major Pharmaceuticals | 0904-7400 | 0904-7400-04 | 30 BLISTER PACK in 1 CARTON (0904-7400-04) / 1 TABLET, FILM COATED in 1 BLISTER PACK |
CYCLOBENZAPRINE HYDROCHLORIDE | cyclobenzaprine hydrochloride | TABLET;ORAL | 078643 | ANDA | Major Pharmaceuticals | 0904-7400 | 0904-7400-06 | 50 BLISTER PACK in 1 CARTON (0904-7400-06) / 1 TABLET, FILM COATED in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Sep 26, 2008 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Sep 26, 2008 | TE: | AB | RLD: | No |
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