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FDA Approval

Chlorzoxazone

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Actavis Pharma, Inc.
DUNS: 119723554
Effective Date
July 31, 2019
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Chlorzoxazone(500 mg in 1 1)

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Chlorzoxazone

Product Details

NDC Product Code
0591-2520
Application Number
ANDA089859
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
July 31, 2019
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
Code: H0DE420U8GClass: ACTIBQuantity: 500 mg in 1 1
DOCUSATE SODIUMInactive
Code: F05Q2T2JA0Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EUClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
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