Details for New Drug Application (NDA): 212254
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NDA 212254 describes CHLORZOXAZONE, which is a drug marketed by Acme Labs, Actavis Elizabeth, Aurobindo Pharma Ltd, Barr, Belcher, Chartwell Rx, Corepharma, Dr Reddys Labs Sa, Endo Operations, Glenmark Pharms Ltd, Mikart, Novitium Pharma, Ohm Labs, Pioneer Pharms, Rising, Senores Pharms, Strides Pharma, Sun Pharm Industries, Teva Pharms Usa Inc, Upsher Smith Labs, and Watson Labs, and is included in thirty-five NDAs. It is available from twenty-five 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. Twenty-five 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. Twenty-five suppliers are listed for this compound. Additional details are available on the chlorzoxazone profile page.
Summary for 212254
| Tradename: | CHLORZOXAZONE |
| Applicant: | Novitium Pharma |
| Ingredient: | chlorzoxazone |
| Patents: | 0 |
Pharmacology for NDA: 212254
| Physiological Effect | Centrally-mediated Muscle Relaxation |
Medical Subject Heading (MeSH) Categories for 212254
Suppliers and Packaging for NDA: 212254
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CHLORZOXAZONE | chlorzoxazone | TABLET;ORAL | 212254 | ANDA | Cameron Pharmaceuticals | 42494-426 | 42494-426-10 | 100 TABLET in 1 BOTTLE, PLASTIC (42494-426-10) |
| CHLORZOXAZONE | chlorzoxazone | TABLET;ORAL | 212254 | ANDA | A-S Medication Solutions | 50090-6689 | 50090-6689-0 | 30 TABLET in 1 BOTTLE (50090-6689-0) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
| Approval Date: | Sep 12, 2019 | TE: | AA | RLD: | No | ||||
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