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FDA Approval

MUPIROCIN

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

FDA Approval Summary

Effective Date
August 1, 2021
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Mupirocin(20 mg in 1 g)

Products1

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

MUPIROCIN

Product Details

NDC Product Code
45802-018
Application Number
ANDA212465
Marketing Category
ANDA (C73584)
Route of Administration
TOPICAL
Effective Date
August 1, 2021
BENZYL ALCOHOLInactive
Code: LKG8494WBHClass: IACT
MupirocinActive
Code: RG38I2P540Class: ACTIMQuantity: 20 mg in 1 g
MINERAL OILInactive
Code: T5L8T28FGPClass: IACT
PHENOXYETHANOLInactive
Code: HIE492ZZ3TClass: IACT
XANTHAN GUMInactive
Code: TTV12P4NEEClass: IACT
POLYOXYL 20 CETOSTEARYL ETHERInactive
Code: YRC528SWUYClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
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