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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
Unit Dose Services
DUNS: 831995316
Effective Date
May 23, 2018
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.

Unit Dose Services

Unit Dose Services

831995316

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
50436-0112
Application Number
ANDA065123
Marketing Category
ANDA (C73584)
Route of Administration
TOPICAL
Effective Date
January 2, 2018
MupirocinActive
Code: D0GX863OA5Class: ACTIBQuantity: 20 mg in 1 g
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
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