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FDA Approval

Zithranol

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

FDA Approval Summary

Company
Elorac Inc.
DUNS: 832590009
Effective Date
October 17, 2014
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Anthralin(1 g in 100 g)

Registrants1

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

Elorac, Inc.

832590009

Products1

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

Zithranol

Product Details

NDC Product Code
42783-111
Route of Administration
TOPICAL
Effective Date
October 17, 2014
GLYCERETH-2 COCOATEInactive
Code: JWM00VS7HCClass: IACT
AnthralinActive
Code: U8CJK0JH5MClass: ACTIBQuantity: 1 g in 100 g
WATERInactive
Code: 059QF0KO0RClass: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
GLYCERYL LAURATEInactive
Code: Y98611C087Class: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
GLYCERYL MYRISTATEInactive
Code: 6992Y81827Class: IACT
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