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FDA Approval

ZITHRANOL-RR

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

FDA Approval Summary

Company
Elorac Inc.
DUNS: 832590009
Effective Date
January 29, 2010
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Anthralin(.012 g in 1 g)

Registrants1

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

Elorac Inc.

832590009

Manufacturing Establishments1

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

Harmony

Elorac Inc.

Elorac Inc.

784625760

Products1

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

ZITHRANOL-RR

Product Details

NDC Product Code
42783-101
Route of Administration
TOPICAL
Effective Date
January 29, 2010
AnthralinActive
Code: U8CJK0JH5MClass: ACTIBQuantity: .012 g in 1 g
anhydrous citric acidInactive
Code: XF417D3PSLClass: IACT
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