Details for New Drug Application (NDA): 089853
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NDA 089853 describes CHLORZOXAZONE, which is a drug marketed by Acme Labs, Actavis Elizabeth, Ajenat Pharms, Aurobindo Pharma Ltd, Barr, 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 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 089853
| Tradename: | CHLORZOXAZONE |
| Applicant: | Aurobindo Pharma Ltd |
| Ingredient: | chlorzoxazone |
| Patents: | 0 |
Pharmacology for NDA: 089853
| Physiological Effect | Centrally-mediated Muscle Relaxation |
Medical Subject Heading (MeSH) Categories for 089853
Suppliers and Packaging for NDA: 089853
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CHLORZOXAZONE | chlorzoxazone | TABLET;ORAL | 089853 | ANDA | Quality Care Products, LLC | 55700-951 | 55700-951-60 | 60 TABLET in 1 BOTTLE (55700-951-60) |
| CHLORZOXAZONE | chlorzoxazone | TABLET;ORAL | 089853 | ANDA | Quality Care Products, LLC | 55700-951 | 55700-951-90 | 90 TABLET in 1 BOTTLE (55700-951-90) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
| Approval Date: | May 4, 1988 | TE: | AA | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 375MG | ||||
| Approval Date: | Aug 17, 2023 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 750MG | ||||
| Approval Date: | Aug 17, 2023 | TE: | AB | RLD: | No | ||||
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