Details for New Drug Application (NDA): 089853
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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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