Details for New Drug Application (NDA): 207314
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NDA 207314 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, Graviti Pharms, 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-three NDAs. It is available from fifty-six 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-eight 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-eight suppliers are listed for this compound. Additional details are available on the cyclobenzaprine hydrochloride profile page.
Summary for 207314
| Tradename: | CYCLOBENZAPRINE HYDROCHLORIDE |
| Applicant: | Macleods Pharms Ltd |
| Ingredient: | cyclobenzaprine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 207314
| Physiological Effect | Centrally-mediated Muscle Relaxation |
Suppliers and Packaging for NDA: 207314
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CYCLOBENZAPRINE HYDROCHLORIDE | cyclobenzaprine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 207314 | ANDA | Macleods Pharmaceuticals Limited | 33342-272 | 33342-272-09 | 60 CAPSULE in 1 BOTTLE (33342-272-09) |
| CYCLOBENZAPRINE HYDROCHLORIDE | cyclobenzaprine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 207314 | ANDA | Macleods Pharmaceuticals Limited | 33342-272 | 33342-272-12 | 10 BLISTER PACK in 1 CARTON (33342-272-12) / 10 CAPSULE in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 15MG | ||||
| Approval Date: | Jul 22, 2024 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 30MG | ||||
| Approval Date: | Jul 22, 2024 | TE: | AB | RLD: | No | ||||
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