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FDA Approval

Taclonex Scalp

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

FDA Approval Summary

Company
Effective Date
August 18, 2010
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Calcipotriol(50 ug in 1 g)
Betamethasone(0.643 mg in 1 g)

Manufacturing Establishments1

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

Physicians Total Care, Inc.

Physicians Total Care, Inc.

194123980

Products1

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

Taclonex Scalp

Product Details

NDC Product Code
54868-6091
Application Number
NDA022185
Marketing Category
NDA (C73594)
Route of Administration
TOPICAL
Effective Date
August 18, 2010
MINERAL OILInactive
Code: T5L8T28FGPClass: IACT
Code: 143NQ3779BClass: ACTIBQuantity: 50 ug in 1 g
HYDROGENATED CASTOR OILInactive
Code: ZF94AP8MEYClass: IACT
Code: 826Y60901UClass: ACTIBQuantity: 0.643 mg in 1 g
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