Details for New Drug Application (NDA): 213126
✉ Email this page to a colleague
NDA 213126 describes CHLORZOXAZONE, which is a drug marketed by Acme Labs, Actavis Elizabeth, Ajenat Pharms, Anda Repository, Aurobindo Pharma Ltd, Barr, Chartwell Rx, Corepharma, Dr Reddys Labs Sa, Glenmark Pharms Ltd, Novitium Pharma, Ohm Labs, Ph Health, Pioneer Pharms, Rising, Senores Pharms, Somerset Theraps Llc, Sun Pharm Industries, Teva Pharms Usa Inc, and Watson Labs, and is included in thirty-five NDAs. It is available from eighteen suppliers. Additional details are available on the CHLORZOXAZONE profile page.
The generic ingredient in CHLORZOXAZONE is chlorzoxazone. There are sixteen drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the chlorzoxazone profile page.
The generic ingredient in CHLORZOXAZONE is chlorzoxazone. There are sixteen drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the chlorzoxazone profile page.
Summary for 213126
| Tradename: | CHLORZOXAZONE |
| Applicant: | Rising |
| Ingredient: | chlorzoxazone |
| Patents: | 0 |
Pharmacology for NDA: 213126
| Physiological Effect | Centrally-mediated Muscle Relaxation |
Medical Subject Heading (MeSH) Categories for 213126
Suppliers and Packaging for NDA: 213126
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CHLORZOXAZONE | chlorzoxazone | TABLET;ORAL | 213126 | ANDA | Rising Pharma Holdings, Inc. | 16571-725 | 16571-725-01 | 100 TABLET in 1 BOTTLE (16571-725-01) |
| CHLORZOXAZONE | chlorzoxazone | TABLET;ORAL | 213126 | ANDA | Rising Pharma Holdings, Inc. | 16571-725 | 16571-725-50 | 500 TABLET in 1 BOTTLE (16571-725-50) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 375MG | ||||
| Approval Date: | Apr 5, 2022 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
| Approval Date: | Apr 5, 2022 | TE: | AA | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 750MG | ||||
| Approval Date: | Apr 5, 2022 | TE: | AB | RLD: | No | ||||
Complete Access Available with Subscription
