MedPath
FDA Approval

Nystatin and Triamcinolone Acetonide

December 11, 2019

HUMAN PRESCRIPTION DRUG LABEL

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

Manufacturing Establishments (2)

Taro Pharmaceuticals Inc.

Taro Pharmaceuticals U.S.A., Inc.

206263295

Taro Pharmaceutical Industries Ltd.

Taro Pharmaceuticals U.S.A., Inc.

600072078

Products (2)

Nystatin and Triamcinolone Acetonide

51672-1272

ANDA063305

ANDA (C73584)

TOPICAL

December 11, 2019

NystatinActive
Code: BDF1O1C72EClass: ACTIBQuantity: 100000 [USP'U] in 1 g
Code: F446C597KAClass: ACTIBQuantity: 1 mg in 1 g
mineral oilInactive
Code: T5L8T28FGPClass: IACT
petrolatumInactive
Code: 4T6H12BN9UClass: IACT

Nystatin and Triamcinolone Acetonide

51672-1263

ANDA062364

ANDA (C73584)

TOPICAL

December 11, 2019

NystatinActive
Code: BDF1O1C72EClass: ACTIBQuantity: 100000 [USP'U] in 1 g
polysorbate 60Inactive
Code: CAL22UVI4MClass: IACT
propylene glycolInactive
Code: 6DC9Q167V3Class: IACT
Code: F446C597KAClass: ACTIBQuantity: 1 mg in 1 g
aluminum hydroxideInactive
Code: 5QB0T2IUN0Class: IACT
titanium dioxideInactive
Code: 15FIX9V2JPClass: IACT
glyceryl monostearateInactive
Code: 230OU9XXE4Class: IACT
sorbic acidInactive
Code: X045WJ989BClass: IACT
petrolatumInactive
Code: 4T6H12BN9UClass: IACT
methylparabenInactive
Code: A2I8C7HI9TClass: IACT
propylparabenInactive
Code: Z8IX2SC1OHClass: IACT
SorbitolInactive
Code: 506T60A25RClass: IACT
© Copyright 2025. All Rights Reserved by MedPath