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FDA Approval

Prednicarbate

CompanyFougera Pharmaceuticals Inc. (DUNS: 043838424)

Effective Date

December 31, 2021

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Prednicarbate(1.0 mg in 1 g)

Products (1)

Prednicarbate

NDC Product Code

0168-0410

Application Number

ANDA077236

Marketing Category

ANDA (C73584)

Route of Administration

TOPICAL

Effective Date

December 31, 2021

Ingredients

PrednicarbateActive

Code: V901LV1K7DClass: ACTIBQuantity: 1.0 mg in 1 g

PETROLATUMInactive

Code: 4T6H12BN9UClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

GLYCERYL MONOOLEATEInactive

Code: C4YAD5F5G6Class: IACT

OCTYLDODECANOLInactive

Code: 461N1O614YClass: IACT

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