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FDA Approval

VANIQA

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

FDA Approval Summary

Company
Effective Date
September 18, 2012
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Eflornithine(139 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.

VANIQA

Product Details

NDC Product Code
54868-5124
Application Number
NDA021145
Marketing Category
NDA (C73594)
Route of Administration
TOPICAL
Effective Date
September 18, 2012
Polyoxyl 20 Cetostearyl EtherInactive
Code: YRC528SWUYClass: IACT
Cetostearyl AlcoholInactive
Code: 2DMT128M1SClass: IACT
DimethiconeInactive
Code: 92RU3N3Y1OClass: IACT
Glyceryl MonostearateInactive
Code: 230OU9XXE4Class: IACT
MethylparabenInactive
Code: A2I8C7HI9TClass: IACT
Mineral OilInactive
Code: T5L8T28FGPClass: IACT
Peg-100 StearateInactive
Code: YD01N1999RClass: IACT
PropylparabenInactive
Code: Z8IX2SC1OHClass: IACT
Stearyl AlcoholInactive
Code: 2KR89I4H1YClass: IACT
PhenoxyethanolInactive
Code: HIE492ZZ3TClass: IACT
WaterInactive
Code: 059QF0KO0RClass: IACT
Code: 4NH22NDW9HClass: ACTIRQuantity: 139 mg in 1 g
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