Application 086413

Type
ANDA
Sponsor
PERRIGO NEW YORK

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDECREAM;TOPICAL0.5%NoNo
002TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDECREAM;TOPICAL0.025%NoNo
003TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDECREAM;TOPICAL0.1%NoNo

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A086413-001TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDE0.5%CREAM / TOPICALATApproved before 1982
A086413-002TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDE0.025%CREAM / TOPICALATApproved before 1982
A086413-003TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALATApproved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A086413-001AT
A086413-002AT
A086413-003AT

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.

Product history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A086413-001TRIAMCINOLONE ACETONIDE0.5%CREAM / TOPICALATApproved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02A086413-002TRIAMCINOLONE ACETONIDE0.025%CREAM / TOPICALATApproved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02A086413-003TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALATApproved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A086413-001TRIAMCINOLONE ACETONIDE0.5%CREAM / TOPICALATApproved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A086413-002TRIAMCINOLONE ACETONIDE0.025%CREAM / TOPICALATApproved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A086413-003TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALATApproved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08A086413-001TRIAMCINOLONE ACETONIDE0.5%CREAM / TOPICALATApproved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08A086413-002TRIAMCINOLONE ACETONIDE0.025%CREAM / TOPICALATApproved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08A086413-003TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALATApproved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A086413-001TRIAMCINOLONE ACETONIDE0.5%CREAM / TOPICALATApproved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A086413-002TRIAMCINOLONE ACETONIDE0.025%CREAM / TOPICALATApproved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A086413-003TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALATApproved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A086413-001TRIAMCINOLONE ACETONIDE0.5%CREAM / TOPICALATApproved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A086413-002TRIAMCINOLONE ACETONIDE0.025%CREAM / TOPICALATApproved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A086413-003TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALATApproved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A086413-001TRIAMCINOLONE ACETONIDE0.5%CREAM / TOPICALATApproved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A086413-002TRIAMCINOLONE ACETONIDE0.025%CREAM / TOPICALATApproved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A086413-003TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALATApproved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A086413-001TRIAMCINOLONE ACETONIDE0.5%CREAM / TOPICALATApproved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A086413-002TRIAMCINOLONE ACETONIDE0.025%CREAM / TOPICALATApproved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A086413-003TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALATApproved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A086413-001TRIAMCINOLONE ACETONIDE0.5%CREAM / TOPICALATApproved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A086413-002TRIAMCINOLONE ACETONIDE0.025%CREAM / TOPICALATApproved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A086413-003TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALATApproved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A086413-001TRIAMCINOLONE ACETONIDE0.5%CREAM / TOPICALATApproved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A086413-002TRIAMCINOLONE ACETONIDE0.025%CREAM / TOPICALATApproved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A086413-003TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALATApproved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A086413-001TRIAMCINOLONE ACETONIDE0.5%CREAM / TOPICALATApproved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10A086413-002TRIAMCINOLONE ACETONIDE0.025%CREAM / TOPICALATApproved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10A086413-003TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALATApproved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A086413-001TRIAMCINOLONE ACETONIDE0.5%CREAM / TOPICALATApproved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A086413-002TRIAMCINOLONE ACETONIDE0.025%CREAM / TOPICALATApproved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A086413-003TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALATApproved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A086413-001TRIAMCINOLONE ACETONIDE0.5%CREAM / TOPICALATApproved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A086413-002TRIAMCINOLONE ACETONIDE0.025%CREAM / TOPICALATApproved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A086413-003TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALATApproved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A086413-001TRIAMCINOLONE ACETONIDE0.5%CREAM / TOPICALATApproved before 19821e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A086413-002TRIAMCINOLONE ACETONIDE0.025%CREAM / TOPICALATApproved before 19821e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A086413-003TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALATApproved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05A086413-001TRIAMCINOLONE ACETONIDE0.5%CREAM / TOPICALATApproved before 19828072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A086413-001AT1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A086413-002AT1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A086413-003AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A086413-001AT131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A086413-002AT131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A086413-003AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08A086413-001AT16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A086413-002AT16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A086413-003AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A086413-001AT1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A086413-002AT1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A086413-003AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A086413-001AT1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A086413-002AT1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A086413-003AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A086413-001AT103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A086413-002AT103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A086413-003AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A086413-001AT12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A086413-002AT12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A086413-003AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A086413-001AT15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A086413-002AT15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A086413-003AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A086413-001AT1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A086413-002AT1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A086413-003AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A086413-001AT1d06236e962d9…
2024-10-29 15:01 UTC2024-10A086413-002AT1d06236e962d9…
2024-10-29 15:01 UTC2024-10A086413-003AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A086413-001AT179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A086413-002AT179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A086413-003AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A086413-001AT1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A086413-002AT1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A086413-003AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A086413-001AT11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A086413-002AT11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A086413-003AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A086413-001AT18072bd15b7f6…

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 · 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEREMEDYREPACK INC.484766b9-cec6-4379-b79d-398c921b32b22026-05-18Adverse reactionsExact identifier
application applno (ANDA): 086413
application number: ANDA086413
ndc (product): 70518-2285
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEBryant Ranch Prepack0844a8f0-116d-40f6-8462-cccd6bcefc8a2026-03-27Adverse reactionsExact identifier
application applno (ANDA): 086413
application number: ANDA086413
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEREMEDYREPACK INC.c76d68dc-78e6-407c-ba9d-5d1c5d13509e2026-02-05Adverse reactionsExact identifier
application applno (ANDA): 086413
application number: ANDA086413
ndc (product): 70518-2403
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEA-S Medication Solutionsda474ee7-ac67-4e62-991d-ca979f13dea22025-05-15Adverse reactionsExact identifier
application applno (ANDA): 086413
application number: ANDA086413
ndc (product): 50090-3704
TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDE CREAMDirect Rxd92e9eaf-3a79-76d7-e053-2995a90ae28d2025-01-21Adverse reactionsExact identifier
application applno (ANDA): 086413
application number: ANDA086413
ndc (product): 72189-330
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEPreferred Pharmaceuticals Incdf6f5944-ba12-4731-9749-9095b3570dd32025-01-16Adverse reactionsExact identifier
application applno (ANDA): 086413
application number: ANDA086413
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEPadagis Israel Pharmaceuticals Ltd5d2fe6c2-3856-47f6-843f-077b2e1080a02024-12-31Adverse reactionsExact identifier
application applno (ANDA): 086413
application number: ANDA086413
ndc (product): 45802-063
ndc (product): 45802-065
ndc (product): 45802-064
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEBryant Ranch Prepack69786597-99f9-4bdc-91bc-c50e5fd682c82024-06-26Adverse reactionsExact identifier
application applno (ANDA): 086413
application number: ANDA086413
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDENuCare Pharmaceuticals,Inc.6a282425-8fdc-1fca-e053-2a91aa0a1c3a2024-06-10Adverse reactionsExact identifier
application applno (ANDA): 086413
application number: ANDA086413
ndc (product): 68071-4397
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEBryant Ranch Prepack2229a9e5-144f-42be-ab12-9c4f4163d22a2024-03-12Adverse reactionsExact identifier
application applno (ANDA): 086413
application number: ANDA086413
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEBryant Ranch Prepack1e9007e8-fcd4-4aff-8d0a-4a43e0b8e6732024-01-12Adverse reactionsExact identifier
application applno (ANDA): 086413
application number: ANDA086413
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEBryant Ranch Prepack2adb56d4-2883-4060-b8cb-65a7662cfdda2024-01-12Adverse reactionsExact identifier
application applno (ANDA): 086413
application number: ANDA086413
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEBryant Ranch Prepack72038652-b15a-4a84-bccc-d50731ac5f032023-11-01Adverse reactionsExact identifier
application applno (ANDA): 086413
application number: ANDA086413
ndc (product): 63629-8707

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 42 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
45802-063Triamcinolone AcetonideTriamcinolone AcetonidePadagis Israel Pharmaceuticals LtdANDACurrent
45802-063Triamcinolone AcetonideTriamcinolone AcetonidePerrigo New York IncANDACurrent
45802-063Triamcinolone AcetonideTriamcinolone AcetonidePerrigo New York IncANDACurrent
45802-064Triamcinolone AcetonideTriamcinolone AcetonidePadagis Israel Pharmaceuticals LtdANDACurrent
45802-064Triamcinolone AcetonideTriamcinolone AcetonidePerrigo New York IncANDACurrent
45802-064Triamcinolone AcetonideTriamcinolone AcetonidePerrigo New York IncANDACurrent
45802-065Triamcinolone AcetonideTriamcinolone AcetonidePadagis Israel Pharmaceuticals LtdANDACurrent
45802-065Triamcinolone AcetonideTriamcinolone AcetonidePerrigo New York IncANDACurrent
45802-065Triamcinolone AcetonideTriamcinolone AcetonidePerrigo New York IncANDACurrent
50090-2095Triamcinolone AcetonideTriamcinolone AcetonideA-S Medication SolutionsANDACurrent
50090-3704Triamcinolone AcetonideTriamcinolone AcetonideA-S Medication SolutionsANDACurrent
53002-9130Triamcinolone AcetonideTriamcinolone AcetonideRPK Pharmaceuticals, Inc.ANDACurrent
53002-9330Triamcinolone AcetonideTriamcinolone AcetonideRPK Pharmaceuticals, Inc.ANDACurrent
63629-8456Triamcinolone AcetonideTriamcinolone AcetonideBryant Ranch PrepackANDACurrent
63629-8456Triamcinolone AcetonideTriamcinolone AcetonideBryant Ranch PrepackANDACurrent
63629-8707Triamcinolone AcetonideTriamcinolone AcetonideBryant Ranch PrepackANDACurrent
63629-8707Triamcinolone AcetonideTriamcinolone AcetonideBryant Ranch PrepackANDACurrent
63629-8707Triamcinolone AcetonideTriamcinolone AcetonideBryant Ranch PrepackANDACurrent
68071-4397Triamcinolone AcetonideTriamcinolone AcetonideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4397Triamcinolone AcetonideTriamcinolone AcetonideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4397Triamcinolone AcetonideTriamcinolone AcetonideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4561Triamcinolone AcetonideTriamcinolone AcetonideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4561Triamcinolone AcetonideTriamcinolone AcetonideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4564Triamcinolone AcetonideTriamcinolone AcetonideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4564Triamcinolone AcetonideTriamcinolone AcetonideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4564Triamcinolone AcetonideTriamcinolone AcetonideNuCare Pharmaceuticals,Inc.ANDACurrent
68788-0149Triamcinolone AcetonideTriamcinolone AcetonidePreferred PharmaceuticalsANDACurrent
68788-0149Triamcinolone AcetonideTriamcinolone AcetonidePreferred Pharmaceuticals, Inc.ANDACurrent
68788-0149Triamcinolone AcetonideTriamcinolone AcetonidePreferred Pharmaceuticals, Inc.ANDACurrent
68788-0149Triamcinolone AcetonideTriamcinolone AcetonidePreferred Pharmaceuticals, Inc.ANDACurrent
68788-0149Triamcinolone AcetonideTriamcinolone AcetonidePreferred Pharmaceuticals, Inc.ANDACurrent
70518-2285Triamcinolone AcetonideTriamcinolone AcetonideREMEDYREPACK INC.ANDACurrent
70518-2285Triamcinolone AcetonideTriamcinolone AcetonideREMEDYREPACK INC.ANDACurrent
70518-2285Triamcinolone AcetonideTriamcinolone AcetonideREMEDYREPACK INC.ANDACurrent
70518-2403Triamcinolone AcetonideTriamcinolone AcetonideREMEDYREPACK INC.ANDACurrent
70518-2403Triamcinolone AcetonideTriamcinolone AcetonideREMEDYREPACK INC.ANDACurrent
70518-2403Triamcinolone AcetonideTriamcinolone AcetonideREMEDYREPACK INC.ANDACurrent
70518-2403Triamcinolone AcetonideTriamcinolone AcetonideREMEDYREPACK INC.ANDACurrent
70859-054NuTriaRX CreamPakTRIAMCINOLONE ACETONIDE, dimethiconeNuCare Pharmaceuticals,Inc.ANDACurrent
70859-054NuTriaRX CreamPakTRIAMCINOLONE ACETONIDE, dimethiconeNuCare Pharmaceuticals,Inc.ANDACurrent
72189-330TRIAMCINOLONE ACETONIDEtriamcinolone acetonide creamDirect RxANDACurrent
72275-739Trivix LiteTriamcinolone Acetonide Cream .1%Primary Pharmaceuticals, Inc.ANDACurrent