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FDA Approval

Mupirocin

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

FDA Approval Summary

Company
Effective Date
February 29, 2012
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Mupirocin(20 mg in 1 g)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Rebel Distributors Corp

Rebel Distributors Corp

118802834

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
42254-137
Application Number
ANDA065085
Marketing Category
ANDA (C73584)
Route of Administration
TOPICAL
Effective Date
September 17, 2009
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQClass: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5PClass: IACT
MupirocinActive
Code: D0GX863OA5Class: ACTIBQuantity: 20 mg in 1 g
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