Alclometasone dipropionate
Alclometasone Dipropionate Cream USP, 0.05%
Approved
Approval ID
3e688309-880a-4890-bf00-90afd19084f6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 3, 2019
Manufacturers
FDA
Taro Pharmaceuticals U.S.A., Inc.
DUNS: 145186370
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Alclometasone dipropionate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51672-1306
Application NumberANDA076587
Product Classification
M
Marketing Category
C73584
G
Generic Name
Alclometasone dipropionate
Product Specifications
Route of AdministrationTOPICAL
Effective DateDecember 3, 2019
FDA Product Classification
INGREDIENTS (12)
Alclometasone dipropionateActive
Quantity: 0.5 mg in 1 g
Code: S56PQL4N1V
Classification: ACTIB
cetyl alcoholInactive
Code: 936JST6JCN
Classification: IACT
Ceteth-20Inactive
Code: I835H2IHHX
Classification: IACT
sodium phosphate, monobasic, unspecified formInactive
Code: 3980JIH2SW
Classification: IACT
Peg-100 StearateInactive
Code: YD01N1999R
Classification: IACT
stearyl alcoholInactive
Code: 2KR89I4H1Y
Classification: IACT
petrolatumInactive
Code: 4T6H12BN9U
Classification: IACT
chlorocresolInactive
Code: 36W53O7109
Classification: IACT
glyceryl monostearateInactive
Code: 230OU9XXE4
Classification: IACT
phosphoric acidInactive
Code: E4GA8884NN
Classification: IACT
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT