FDA.reportPublic FDA data

Application 086414

Type
ANDA
Sponsor
PERRIGO NEW YORK

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDECREAM;TOPICAL0.1%NoNo

Source provenance: Browse the complete Orange Book source catalog.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDENuCare Pharmaceuticals,Inc.5439cd3c-da8d-3b96-e054-00144ff8d46c2026-01-21Adverse reactionsExact identifier
application applno (ANDA): 086414
application number: ANDA086414
ndc (product): 66267-933
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDENuCare Pharmaceuticals,Inc.696cd64f-28dd-3dae-e053-2a91aa0a0c762025-02-13Adverse reactionsExact identifier
application applno (ANDA): 086414
application number: ANDA086414
ndc (product): 68071-4383
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEProficient Rx LP4aa792cc-7cd4-4a98-8730-fa36feaa9b7a2023-02-01Adverse reactionsExact identifier
application applno (ANDA): 086414
application number: ANDA086414
ndc (product): 63187-870

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
49999-150Triamcinolone AcetonideTriamcinolone AcetonideLake Erie Medical DBA Quality Care Products LLCANDACurrent
50090-2094Triamcinolone AcetonideTriamcinolone AcetonideA-S Medication SolutionsANDACurrent
52959-096Triamcinolone AcetonideTriamcinolone AcetonideH.J. Harkins Company, Inc.ANDACurrent
53002-9330Triamcinolone AcetonideTriamcinolone AcetonideRPK Pharmaceuticals, Inc.ANDACurrent
63187-870Triamcinolone AcetonideTriamcinolone AcetonideProficient Rx LPANDACurrent
63187-870Triamcinolone AcetonideTriamcinolone AcetonideProficient Rx LPANDACurrent
63187-870Triamcinolone AcetonideTriamcinolone AcetonideProficient Rx LPANDACurrent
66267-933Triamcinolone AcetonideTriamcinolone AcetonideNuCare Pharmaceuticals,Inc.ANDACurrent
66267-933Triamcinolone AcetonideTriamcinolone AcetonideNuCare Pharmaceuticals,Inc.ANDACurrent
66267-933Triamcinolone AcetonideTriamcinolone AcetonideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4383Triamcinolone AcetonideTriamcinolone AcetonideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4383Triamcinolone AcetonideTriamcinolone AcetonideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4383Triamcinolone AcetonideTriamcinolone AcetonideNuCare Pharmaceuticals,Inc.ANDACurrent
68788-9172Triamcinolone AcetonideTriamcinolone AcetonidePreferred PharmaceuticalsANDACurrent
68788-9172Triamcinolone AcetonideTriamcinolone AcetonidePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9172Triamcinolone AcetonideTriamcinolone AcetonidePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9172Triamcinolone AcetonideTriamcinolone AcetonidePreferred Pharmaceuticals, Inc.ANDACurrent
76413-129Triamcinolone AcetonideTriamcinolone AcetonideCentral Texas Community Health CentersANDACurrent