NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE

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

FDA Approval Summary

Company

DIRECT RX

DUNS: 079254320

Effective Date

January 21, 2020

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Neomycin(3.5 mg in 1 g)

Dexamethasone(1 mg in 1 g)

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

Registrants1

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

DIRECT RX

DUNS Number

079254320

Manufacturing Establishments1

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

DIRECT RX

Labeler

DIRECT RX

Registrant

DIRECT RX

DUNS Number

079254320

Products1

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