MedPath

Dovonex

Approved
Approval ID

1c02cc96-ecaa-467b-9acb-7cae57ec8e87

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 14, 2009

Manufacturers
FDA

Physicians Total Care, Inc.

DUNS: 194123980

Products 1

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

Calcipotriene

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code54868-6057
Application NumberNDA020611
Product Classification
M
Marketing Category
C73594
G
Generic Name
Calcipotriene
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 14, 2009
FDA Product Classification

INGREDIENTS (7)

HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
DIISOPROPANOLAMINEInactive
Code: 0W44HYL8T5
Classification: IACT
MENTHOLInactive
Code: L7T10EIP3A
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CALCIPOTRIENEActive
Quantity: 0.05 mg in 1 mL
Code: 143NQ3779B
Classification: ACTIB
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT

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Dovonex - FDA Drug Approval Details