Nystatin and Triamcinolone Acetonide

Company

E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. (DUNS: 043838424)

Effective Date

November 29, 2018

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Nystatin(100000 [USP'U] in 1 g)

Products (1)

NDC Product Code

0168-0089

Application Number

ANDA062602

Marketing Category

ANDA (C73584)

Route of Administration

TOPICAL

Effective Date

November 29, 2018

Ingredients

Code: BDF1O1C72EClass: ACTIBQuantity: 100000 [USP'U] in 1 g

Code: F446C597KAClass: ACTIBQuantity: 1 mg in 1 g

HIGH DENSITY POLYETHYLENEInactive

Code: UG00KM4WR7Class: IACT

MINERAL OILInactive

Code: T5L8T28FGPClass: IACT