Details for New Drug Application (NDA): 078218
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NDA 078218 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, Aurobindo Pharma, Chartwell Rx, Invagen Pharms, Jubilant Cadista, Kvk Tech, Oxford Pharms, Pliva, Prinston Inc, Rising, Rubicon Research, Sandoz, Sun Pharm Inds Ltd, Tp Anda Holdings, Unichem, and Watson Labs, and is included in twenty-three NDAs. It is available from fifty-eight suppliers. Additional details are available on the CYCLOBENZAPRINE HYDROCHLORIDE profile page.
The generic ingredient in CYCLOBENZAPRINE HYDROCHLORIDE is cyclobenzaprine hydrochloride. There is one drug master file entry for this compound. Sixty 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 is one drug master file entry for this compound. Sixty suppliers are listed for this compound. Additional details are available on the cyclobenzaprine hydrochloride profile page.
Summary for 078218
| Tradename: | CYCLOBENZAPRINE HYDROCHLORIDE |
| Applicant: | Chartwell Rx |
| Ingredient: | cyclobenzaprine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 078218
| Physiological Effect | Centrally-mediated Muscle Relaxation |
Suppliers and Packaging for NDA: 078218
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CYCLOBENZAPRINE HYDROCHLORIDE | cyclobenzaprine hydrochloride | TABLET;ORAL | 078218 | ANDA | Amneal Pharmaceuticals of New York LLC | 53746-540 | 53746-540-01 | 100 TABLET, FILM COATED in 1 BOTTLE (53746-540-01) |
| CYCLOBENZAPRINE HYDROCHLORIDE | cyclobenzaprine hydrochloride | TABLET;ORAL | 078218 | ANDA | Amneal Pharmaceuticals of New York LLC | 53746-540 | 53746-540-05 | 500 TABLET, FILM COATED in 1 BOTTLE (53746-540-05) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | Apr 18, 2008 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | Jun 19, 2015 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 7.5MG | ||||
| Approval Date: | Nov 3, 2020 | TE: | AB | RLD: | No | ||||
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