Details for New Drug Application (NDA): 077563
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NDA 077563 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-nine 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. Sixty-one 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. Sixty-one suppliers are listed for this compound. Additional details are available on the cyclobenzaprine hydrochloride profile page.
Summary for 077563
| Tradename: | CYCLOBENZAPRINE HYDROCHLORIDE |
| Applicant: | Jubilant Cadista |
| Ingredient: | cyclobenzaprine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 077563
| Physiological Effect | Centrally-mediated Muscle Relaxation |
Suppliers and Packaging for NDA: 077563
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CYCLOBENZAPRINE HYDROCHLORIDE | cyclobenzaprine hydrochloride | TABLET;ORAL | 077563 | ANDA | AvKARE | 42291-154 | 42291-154-10 | 1000 TABLET, FILM COATED in 1 BOTTLE (42291-154-10) |
| CYCLOBENZAPRINE HYDROCHLORIDE | cyclobenzaprine hydrochloride | TABLET;ORAL | 077563 | ANDA | AvKARE | 42291-154 | 42291-154-12 | 120 TABLET, FILM COATED in 1 BOTTLE (42291-154-12) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | Apr 19, 2006 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | Apr 19, 2006 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 7.5MG | ||||
| Approval Date: | Aug 25, 2017 | TE: | AB | RLD: | No | ||||
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