Details for New Drug Application (NDA): 077797
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NDA 077797 describes CYCLOBENZAPRINE HYDROCHLORIDE, which is a drug marketed by Apotex, Macleods Pharms Ltd, Novast Labs, Twi Pharms Inc, Actavis Labs Fl Inc, Aiping Pharm Inc, Anda Repository, Aurobindo Pharma, Chartwell Rx, Invagen Pharms, Jubilant Cadista, Kvk Tech, Oxford Pharms, Pliva, Prinston Inc, Rising, Rubicon, Sandoz, Sun Pharm Inds Ltd, Unichem, and Watson Labs, and is included in twenty-two NDAs. It is available from fifty-four suppliers. Additional details are available on the CYCLOBENZAPRINE HYDROCHLORIDE profile page.
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.
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 077797
| Tradename: | CYCLOBENZAPRINE HYDROCHLORIDE |
| Applicant: | Prinston Inc |
| Ingredient: | cyclobenzaprine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 077797
| Physiological Effect | Centrally-mediated Muscle Relaxation |
Suppliers and Packaging for NDA: 077797
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CYCLOBENZAPRINE HYDROCHLORIDE | cyclobenzaprine hydrochloride | TABLET;ORAL | 077797 | ANDA | Solco Healthcare U.S., LLC | 43547-399 | 43547-399-01 | 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43547-399-01) |
| CYCLOBENZAPRINE HYDROCHLORIDE | cyclobenzaprine hydrochloride | TABLET;ORAL | 077797 | ANDA | Solco Healthcare U.S., LLC | 43547-399 | 43547-399-10 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43547-399-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | Feb 28, 2007 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | Feb 28, 2007 | TE: | AB | RLD: | No | ||||
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