Details for New Drug Application (NDA): 212743
NDA 212743 describes CHLORZOXAZONE, which is a drug marketed by Actavis Elizabeth, Ajenat Pharms, Aurobindo Pharma Ltd, Barr, Chartwell Rx, Dr Reddys Labs Sa, Glenmark Pharms Ltd, Macleods Pharms, Novitium Pharma, Ohm Labs, Ph Health, Pharmazone, Pharmobedient, Pioneer Pharms, Rising, Somerset Theraps Llc, Sun Pharm Industries, Teva Pharms Usa Inc, and Watson Labs, and is included in thirty-five NDAs. It is available from nineteen suppliers. Additional details are available on the CHLORZOXAZONE profile page.
The generic ingredient in CHLORZOXAZONE is chlorzoxazone. There is one drug master file entry for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the chlorzoxazone profile page.
The generic ingredient in CHLORZOXAZONE is chlorzoxazone. There is one drug master file entry for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the chlorzoxazone profile page.
Summary for 212743
| Tradename: | CHLORZOXAZONE |
| Applicant: | Ph Health |
| Ingredient: | chlorzoxazone |
| Patents: | 0 |
Pharmacology for NDA: 212743
| Physiological Effect | Centrally-mediated Muscle Relaxation |
Medical Subject Heading (MeSH) Categories for 212743
Suppliers and Packaging for NDA: 212743
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CHLORZOXAZONE | chlorzoxazone | TABLET;ORAL | 212743 | ANDA | Par Health USA, LLC | 0254-2005 | 0254-2005-01 | 100 TABLET in 1 BOTTLE (0254-2005-01) |
| CHLORZOXAZONE | chlorzoxazone | TABLET;ORAL | 212743 | ANDA | Par Health USA, LLC | 0254-2053 | 0254-2053-01 | 100 TABLET in 1 BOTTLE (0254-2053-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 750MG | ||||
| Approval Date: | Nov 2, 2020 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 375MG | ||||
| Approval Date: | Apr 29, 2021 | TE: | AB | RLD: | No | ||||
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