Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Hydrocortisone

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

FDA Approval Summary

Company

MWI

DUNS: 019926120

Effective Date

February 2, 2022

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Neomycin(3.5 mg in 1 g)

Polymyxin B(10000 [USP'U] in 1 g)

Bacitracin(400 [USP'U] in 1 g)

Hydrocortisone(10 mg in 1 g)

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

Akorn Operating Company LLC

DUNS Number

117693100

Manufacturing Establishments1

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

Akorn

Labeler

MWI

Registrant

Akorn Operating Company LLC

DUNS Number

117696840

Products1

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