Details for New Drug Application (NDA): 213324
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The generic ingredient in CYCLOBENZAPRINE HYDROCHLORIDE is cyclobenzaprine hydrochloride. There are sixteen drug master file entries for this compound. Fifty-eight suppliers are listed for this compound. Additional details are available on the cyclobenzaprine hydrochloride profile page.
Summary for 213324
Tradename: | CYCLOBENZAPRINE HYDROCHLORIDE |
Applicant: | Unichem |
Ingredient: | cyclobenzaprine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 213324
Physiological Effect | Centrally-mediated Muscle Relaxation |
Suppliers and Packaging for NDA: 213324
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CYCLOBENZAPRINE HYDROCHLORIDE | cyclobenzaprine hydrochloride | TABLET;ORAL | 213324 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8508 | 0615-8508-05 | 15 TABLET, FILM COATED in 1 BLISTER PACK (0615-8508-05) |
CYCLOBENZAPRINE HYDROCHLORIDE | cyclobenzaprine hydrochloride | TABLET;ORAL | 213324 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8508 | 0615-8508-39 | 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8508-39) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Jul 6, 2020 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 7.5MG | ||||
Approval Date: | Jul 6, 2020 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Jul 5, 2020 | TE: | AB | RLD: | No |
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