Details for New Drug Application (NDA): 212743
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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 212743
Tradename: | CHLORZOXAZONE |
Applicant: | Endo Operations |
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 | Endo USA, Inc. | 0254-2005 | 0254-2005-01 | 100 TABLET in 1 BOTTLE (0254-2005-01) |
CHLORZOXAZONE | chlorzoxazone | TABLET;ORAL | 212743 | ANDA | Endo USA, Inc. | 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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