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FDA Approval

acetazolamide

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

FDA Approval Summary

Company
AvKARE
DUNS: 796560394
Effective Date
January 9, 2024
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Acetazolamide(125 mg in 1 1)

Products2

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

acetazolamide

Product Details

NDC Product Code
42291-089
Application Number
ANDA205530
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
January 9, 2024
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
Code: O3FX965V0IClass: ACTIBQuantity: 125 mg in 1 1
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT

acetazolamide

Product Details

NDC Product Code
42291-090
Application Number
ANDA205530
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
January 9, 2024
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
Code: O3FX965V0IClass: ACTIBQuantity: 250 mg in 1 1
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
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