Clocortolone Pivalate
Clocortolone Pivalate Cream USP, 0.1%
Approved
Approval ID
88d9a7cf-31b5-4b85-9827-0ecce328e6a0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 21, 2021
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.
Clocortolone Pivalate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51672-4166
Application NumberANDA206370
Product Classification
M
Marketing Category
C73584
G
Generic Name
Clocortolone Pivalate
Product Specifications
Route of AdministrationTOPICAL
Effective DateDecember 21, 2021
FDA Product Classification
INGREDIENTS (12)
Clocortolone PivalateActive
Quantity: 0.001 g in 1 g
Code: QBL8IZH14X
Classification: ACTIB
polyoxyl 40 stearateInactive
Code: 13A4J4NH9I
Classification: IACT
propylparabenInactive
Code: Z8IX2SC1OH
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
benzyl alcoholInactive
Code: LKG8494WBH
Classification: IACT
carbomer homopolymer type b (allyl pentaerythritol crosslinked)Inactive
Code: HHT01ZNK31
Classification: IACT
edetate disodiumInactive
Code: 7FLD91C86K
Classification: IACT
methylparabenInactive
Code: A2I8C7HI9T
Classification: IACT
mineral oilInactive
Code: T5L8T28FGP
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
stearyl alcoholInactive
Code: 2KR89I4H1Y
Classification: IACT
petrolatumInactive
Code: 4T6H12BN9U
Classification: IACT