Details for New Drug Application (NDA): 091281
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The generic ingredient in CYCLOBENZAPRINE HYDROCHLORIDE is cyclobenzaprine hydrochloride. There are sixteen drug master file entries for this compound. Fifty-six suppliers are listed for this compound. Additional details are available on the cyclobenzaprine hydrochloride profile page.
Summary for 091281
Tradename: | CYCLOBENZAPRINE HYDROCHLORIDE |
Applicant: | Twi Pharms Inc |
Ingredient: | cyclobenzaprine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 091281
Physiological Effect | Centrally-mediated Muscle Relaxation |
Suppliers and Packaging for NDA: 091281
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CYCLOBENZAPRINE HYDROCHLORIDE | cyclobenzaprine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 091281 | ANDA | TWi Pharmaceuticals, Inc. | 24979-035 | 24979-035-04 | 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (24979-035-04) |
CYCLOBENZAPRINE HYDROCHLORIDE | cyclobenzaprine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 091281 | ANDA | TWi Pharmaceuticals, Inc. | 24979-036 | 24979-036-04 | 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (24979-036-04) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 15MG | ||||
Approval Date: | Jan 31, 2013 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 30MG | ||||
Approval Date: | Jan 31, 2013 | TE: | AB | RLD: | No |
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