FDA.reportPublic FDA data

Application 062364

Type
ANDA
Sponsor
TARO

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A062364-001NYSTATIN AND TRIAMCINOLONE ACETONIDENYSTATIN; TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALATRS1987-12-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A062364-001AT

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A062364-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALATRS1987-12-22a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A062364-001AT1a50c72e98297…

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. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nystatin and Triamcinolone AcetonideNYSTATIN AND TRIAMCINOLONE ACETONIDEREMEDYREPACK INC.ea065dd4-dfd3-46a2-92de-8a0b49cb94552026-01-14Adverse reactionsExact identifier
application applno (ANDA): 062364
application number: ANDA062364
ndc (product): 70518-1114
Nystatin and Triamcinolone AcetonideNYSTATIN AND TRIAMCINOLONE ACETONIDEPreferred Pharmaceuticals Inc.4fd65dbf-8e50-4a4a-b06d-e5abab0f3dcd2025-08-28Adverse reactionsExact identifier
application applno (ANDA): 062364
application number: ANDA062364
Nystatin and Triamcinolone AcetonideNYSTATIN AND TRIAMCINOLONE ACETONIDESun Pharmaceutical Industries, Inc.2fd97fc5-cae5-43dd-a3c7-c9a03876153e2025-07-07Adverse reactionsExact identifier
application applno (ANDA): 062364
application number: ANDA062364
ndc (product): 51672-1263
Nystatin and Triamcinolone AcetonideNYSTATIN AND TRIAMCINOLONE ACETONIDENuCare Pharmaceuticals,Inc.90a58c0e-85cf-3aad-e053-2a95a90a316a2024-06-19Adverse reactionsExact identifier
application applno (ANDA): 062364
application number: ANDA062364
ndc (product): 68071-5037

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
21695-185Nystatin and TriamcinoloneNystatin and Triamcinolone AcetonideRebel Distributors CorpANDACurrent
51672-1263Nystatin and Triamcinolone AcetonideNystatin and Triamcinolone AcetonideTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
51672-1263Nystatin and Triamcinolone AcetonideNystatin and Triamcinolone AcetonideTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
52959-558Nystatin and Triamcinolone AcetonideNystatin and Triamcinolone AcetonideH.J. Harkins Company, Inc.ANDACurrent
53002-9360Nystatin and Triamcinolone AcetonideNystatin and Triamcinolone AcetonideRPK Pharmaceuticals, Inc.ANDACurrent
68071-5037Nystatin and Triamcinolone AcetonideNystatin and Triamcinolone AcetonideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5037Nystatin and Triamcinolone AcetonideNystatin and Triamcinolone AcetonideNuCare Pharmaceuticals,Inc.ANDACurrent
70518-1114Nystatin and Triamcinolone AcetonideNystatin and Triamcinolone AcetonideREMEDYREPACK INC.ANDACurrent
70518-1114Nystatin and Triamcinolone AcetonideNystatin and Triamcinolone AcetonideREMEDYREPACK INC.ANDACurrent
71085-009Nystatin and Triamcinolone AcetonideNystatin and Triamcinolone AcetonideIPG PHARMACEUTICALS, INC.ANDACurrent
76413-120Nystatin and Triamcinolone AcetonideNystatin and Triamcinolone AcetonideCentral Texas Community Health CentersANDACurrent