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FDA Approval

MINOXIDIL

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

FDA Approval Summary

Company
AvKARE
DUNS: 796560394
Effective Date
October 26, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Minoxidil(10 mg in 1 1)

Products2

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

MINOXIDIL

Product Details

NDC Product Code
42291-619
Application Number
ANDA072709
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
October 26, 2023
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
MinoxidilActive
Code: 5965120SH1Class: ACTIBQuantity: 10 mg in 1 1

MINOXIDIL

Product Details

NDC Product Code
42291-618
Application Number
ANDA072708
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
October 26, 2023
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
MinoxidilActive
Code: 5965120SH1Class: ACTIBQuantity: 2.5 mg in 1 1
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