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FDA Approval

Ibuprofen

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

FDA Approval Summary

Company
Walgreens
DUNS: 008965063
Effective Date
May 7, 2025
Labeling Type
HUMAN OTC DRUG LABEL
Ibuprofen(200 mg in 1 1)

Products1

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

Ibuprofen

Product Details

NDC Product Code
0363-0749
Application Number
ANDA206568
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
May 7, 2025
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4TClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
SORBITOLInactive
Code: 506T60A25RClass: IACT
SORBITANInactive
Code: 6O92ICV9RUClass: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7UClass: IACT
IbuprofenActive
Code: WK2XYI10QMClass: ACTIBQuantity: 200 mg in 1 1
GELATINInactive
Code: 2G86QN327LClass: IACT
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