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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

NDC Product Code51672-4166
Application NumberANDA206370
Marketing CategoryC73584
Route of AdministrationTOPICAL
Effective DateDecember 21, 2021
Generic NameClocortolone Pivalate

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

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Clocortolone Pivalate - FDA Drug Approval Details