FDA.reportPublic FDA data

Application 209990

Type
ANDA
Sponsor
AMNEAL PHARMS LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NYSTATIN AND TRIAMCINOLONE ACETONIDENYSTATIN; TRIAMCINOLONE ACETONIDECREAM;TOPICAL100,000 UNITS/GM;0.1%NoNo

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A209990-001NYSTATIN AND TRIAMCINOLONE ACETONIDENYSTATIN; TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALAT2018-02-15

Therapeutic equivalence codes#

Application-product, TE code table
Application-productTE code
A209990-001AT

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nystatin and triamcinolone acetonideNYSTATIN AND TRIAMCINOLONE ACETONIDENuCare Pharmaceuticals, Inc.4c122a83-a66a-15d6-e063-6294a90acfaa2026-03-02Adverse reactionsName fallback
Nystatin and triamcinolone acetonideNYSTATIN AND TRIAMCINOLONE ACETONIDEPreferred Pharmaceuticals Inc.c529567b-7061-4389-8c7a-20ef2b22c5912026-01-16Adverse reactionsName fallback
Nystatin and Triamcinolone AcetonideNYSTATIN AND TRIAMCINOLONE ACETONIDEREMEDYREPACK INC.ea065dd4-dfd3-46a2-92de-8a0b49cb94552026-01-14Adverse reactionsName fallback
Nystatin and Triamcinolone AcetonideNYSTATIN AND TRIAMCINOLONE ACETONIDECrown Laboratories54aae5d3-e482-4da0-a1b2-0ed70e6c29152026-01-12Adverse reactionsName fallback
Nystatin and Triamcinolone AcetonideNYSTATIN AND TRIAMCINOLONE ACETONIDELupin Pharmaceuticals, Inc.09140e74-c5ea-4c45-a5b1-e6f7f9ee1a232025-11-28Adverse reactionsName fallback
NYSTATIN AND TRIAMCINOLONE ACETONIDENYSTATIN, TRIAMCINOLONE ACETONIDEBryant Ranch Prepackf81f461b-54cd-45bf-bf96-da77a5edc1e62025-10-28Adverse reactionsName fallback
Nystatin and Triamcinolone AcetonideNYSTATIN AND TRIAMCINOLONE ACETONIDEBryant Ranch Prepackd36c64f7-5481-45e4-ac9c-e16ae2194c6e2025-10-22Adverse reactionsName fallback
Nystatin and Triamcinolone AcetonideNYSTATIN AND TRIAMCINOLONE ACETONIDEBryant Ranch Prepack26fd7fb6-6eeb-47f1-bbc4-001e84f996252025-10-22Adverse reactionsName fallback
Nystatin and Triamcinolone AcetonideNYSTATIN AND TRIAMCINOLONE ACETONIDEEncube Ethicals, Inc.d33829fc-86df-4e28-82c3-9dbcd8a9e28d2025-08-29Adverse reactionsName fallback
Nystatin and Triamcinolone AcetonideNYSTATIN AND TRIAMCINOLONE ACETONIDEPreferred Pharmaceuticals Inc., USAdc886fb9-535c-4fd8-959a-f590a3bf36682025-08-28Adverse reactionsName fallback
Nystatin and Triamcinolone AcetonideNYSTATIN AND TRIAMCINOLONE ACETONIDEPreferred Pharmaceuticals Inc.4fd65dbf-8e50-4a4a-b06d-e5abab0f3dcd2025-08-28Adverse reactionsName fallback
Nystatin and Triamcinolone AcetonideNYSTATIN AND TRIAMCINOLONE ACETONIDESun Pharmaceutical Industries, Inc.2fd97fc5-cae5-43dd-a3c7-c9a03876153e2025-07-07Adverse reactionsName fallback
NYSTATIN AND TRIAMCINOLONE ACETONIDENYSTATIN, TRIAMCINOLONE ACETONIDEBryant Ranch Prepackc82fc464-d021-4a7c-8141-46d3d80134a22025-05-07Adverse reactionsName fallback
Nystatin and Triamcinolone AcetonideNYSTATIN AND TRIAMCINOLONE ACETONIDEAlembic Pharmaceuticals Limited51966a3b-dc09-4f41-941f-0f9247974d882025-04-08Adverse reactionsName fallback
Nystatin and Triamcinolone AcetonideNYSTATIN AND TRIAMCINOLONE ACETONIDEPreferred Pharmaceuticals Inc.6115a76d-4bad-4829-b2bc-3a077154109d2025-01-20Adverse reactionsName fallback
Nystatin and Triamcinolone AcetonideNYSTATIN AND TRIAMCINOLONE ACETONIDEBryant Ranch Prepackec28a12b-96f8-44ff-a440-8cff34ac20952024-11-06Adverse reactionsName fallback
NYSTATIN AND TRIAMCINOLONE ACETONIDENYSTATIN, TRIAMCINOLONE ACETONIDENuCare Pharmaceuticals,Inc.c8beaa42-eb3a-d160-e053-2a95a90a31082024-10-03Adverse reactionsName fallback
NYSTATIN AND TRIAMCINOLONE ACETONIDENYSTATIN, TRIAMCINOLONE ACETONIDEBryant Ranch Prepackb3056a63-d149-4ed4-84bc-918f5ff94a622024-08-22Adverse reactionsName fallback
Nystatin and Triamcinolone AcetonideNYSTATIN AND TRIAMCINOLONE ACETONIDEBryant Ranch Prepackc62979d3-c9a4-4d94-956e-30760266daf42024-08-20Adverse reactionsName fallback
Nystatin and Triamcinolone AcetonideNYSTATIN AND TRIAMCINOLONE ACETONIDEZydus Lifesciences Limited7b878bc9-9a6f-41b8-9d5a-287c01d8cf7f2024-08-16Name fallback

Adverse reactions cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

adverse reactions

ADVERSE REACTIONS A single case (approximately one percent of patients studied) of acneiform eruption occurred with use of combined nystatin and triamcinolone acetonide in clinical studies. Nystatin is virtually nontoxic and nonsensitizing and is well tolerated by all age groups, even during prolonged use. Rarely, irritation may occur. The following local adverse reactions are reported infrequently with topical corticosteroids (reactions are listed in an approximate decreasing order of occurrence): burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, perioral secondary infection, skin atrophy, striae and miliaria.