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Tovet (emollient formulation)

These highlights do not include all the information needed to use TOVET (CLOBETASOL PROPIONATE) FOAM (EMULSION) safely and effectively. See full prescribing information for TOVET (CLOBETASOL PROPIONATE) FOAM (EMULSION). TOVET (CLOBETASOL PROPIONATE) foam, 0.05% (Emollient Formulation) For topical use Initial U.S. Approval: 1985

Approved
Approval ID

4d5c5b14-9e4f-4d43-a336-e4ae71d34e42

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 27, 2023

Manufacturers
FDA

Medimetriks Pharmaceuticals, Inc.

DUNS: 019903816

Products 2

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

CLOBETASOL PROPIONATE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code43538-953
Application NumberANDA201402
Product Classification
M
Marketing Category
C73584
G
Generic Name
CLOBETASOL PROPIONATE
Product Specifications
Effective DateApril 30, 2022
FDA Product Classification

CLOBETASOL PROPIONATE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code43538-952
Application NumberANDA201402
Product Classification
M
Marketing Category
C73584
G
Generic Name
CLOBETASOL PROPIONATE
Product Specifications
Route of AdministrationTOPICAL
Effective DateApril 30, 2022
FDA Product Classification

INGREDIENTS (12)

CLOBETASOL PROPIONATEActive
Quantity: 0.5 mg in 1 g
Code: 779619577M
Classification: ACTIB
cetyl alcoholInactive
Code: 936JST6JCN
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
cyclomethiconeInactive
Code: NMQ347994Z
Classification: IACT
glycerinInactive
Code: PDC6A3C0OX
Classification: IACT
isopropyl myristateInactive
Code: 0RE8K4LNJS
Classification: IACT
polyoxyl 20 cetostearyl etherInactive
Code: YRC528SWUY
Classification: IACT
potassium citrateInactive
Code: EE90ONI6FF
Classification: IACT
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
sorbitan monolaurateInactive
Code: 6W9PS8B71J
Classification: IACT
phenoxyethanolInactive
Code: HIE492ZZ3T
Classification: IACT

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Tovet (emollient formulation) - FDA Drug Approval Details