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FDA Approval

ACETAZOLAMIDE EXTENDED-RELEASE

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

FDA Approval Summary

Company
AvPAK
DUNS: 832926666
Effective Date
January 9, 2024
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Acetazolamide(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.

ACETAZOLAMIDE EXTENDED-RELEASE

Product Details

NDC Product Code
50268-042
Application Number
ANDA207401
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
January 9, 2024
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671PClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
D&C RED NO. 28Inactive
Code: 767IP0Y5NHClass: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302Class: IACT
ALCOHOLInactive
Code: 3K9958V90MClass: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3Class: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4TClass: IACT
AMMONIAInactive
Code: 5138Q19F1XClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
Code: O3FX965V0IClass: ACTIBQuantity: 500 mg in 1 1
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