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SORILUX

These highlights do not include all the information needed to use SORILUX safely and effectively. See full prescribing information for SORILUX. SORILUX (calcipotriene) foam, for topical use Initial U.S. Approval: 1993

Approved
Approval ID

51f208d0-7b3f-44cc-8bed-92fa3d2e7bbe

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 27, 2023

Manufacturers
FDA

Mayne Pharma

DUNS: 867220261

Products 1

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

calcipotriene

PRODUCT DETAILS

NDC Product Code51862-376
Application NumberNDA022563
Marketing CategoryC73594
Route of AdministrationTOPICAL
Effective DateMarch 31, 2023
Generic Namecalcipotriene

INGREDIENTS (12)

calcipotrieneActive
Quantity: 50 ug in 1 g
Code: 143NQ3779B
Classification: ACTIB
ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJS
Classification: IACT
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
LIGHT MINERAL OILInactive
Code: N6K5787QVP
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORMInactive
Code: GR686LBA74
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
POLYOXYL 20 CETOSTEARYL ETHERInactive
Code: YRC528SWUY
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
STEARYL ALCOHOLInactive
Code: 2KR89I4H1Y
Classification: IACT
.ALPHA.-TOCOPHEROL, DL-Inactive
Code: 7QWA1RIO01
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
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SORILUX - FDA Approval | MedPath