Application 089798

Type
ANDA
Sponsor
ACP NIMBLE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TRIAMCINOLONE 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A089798-001TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1991-05-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A089798-001AT

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.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A089798-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1991-05-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A089798-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1991-05-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A089798-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1991-05-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A089798-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1991-05-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A089798-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1991-05-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A089798-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1991-05-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A089798-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1991-05-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A089798-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1991-05-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A089798-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1991-05-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A089798-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1991-05-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A089798-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1991-05-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A089798-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1991-05-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A089798-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1991-05-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A089798-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1991-05-318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A089798-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1991-05-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A089798-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1991-05-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A089798-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1991-05-314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A089798-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1991-05-3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A089798-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1991-05-31bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A089798-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1991-05-31782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A089798-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1991-05-3187673890dc5c…
2021-03-12 10:30 UTC2021-03A089798-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1991-05-315aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A089798-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1991-05-318869cabd3fbd…
2020-11-12 02:37 UTC2020-11A089798-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1991-05-31c0c555d07b60…
2019-12-14 00:12 UTC2019-12A089798-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1991-05-313f01610625f2…
2019-09-15 20:21 UTC2019-09A089798-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1991-05-31b00525d2431f…
2019-07-19 19:46 UTC2019-07A089798-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1991-05-31ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A089798-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1991-05-316a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A089798-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1991-05-311c564ffb4f44…
2023-12-20 04:57 UTC2023-12A089798-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1991-05-31ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A089798-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1991-05-31a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A089798-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1991-05-319b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A089798-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1991-05-31a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A089798-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1991-05-313f0d92c62455…
2023-05-13 08:27 UTC2023-05A089798-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1991-05-31053a50430f4f…
2023-01-26 05:58 UTC2023-01A089798-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1991-05-313bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A089798-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1991-05-313a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A089798-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1991-05-31f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A089798-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1991-05-31e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A089798-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1991-05-31cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A089798-001AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A089798-001AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08A089798-001AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A089798-001AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A089798-001AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A089798-001AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A089798-001AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A089798-001AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A089798-001AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A089798-001AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A089798-001AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A089798-001AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A089798-001AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A089798-001AT18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A089798-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A089798-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A089798-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A089798-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A089798-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A089798-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A089798-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A089798-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A089798-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A089798-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A089798-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A089798-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A089798-001AT1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A089798-001AT16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A089798-001AT11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A089798-001AT1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A089798-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A089798-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A089798-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A089798-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05A089798-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01A089798-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A089798-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A089798-001AT1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A089798-001AT1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A089798-001AT1cb3db0bc1861…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDECosette Pharmaceuticals, Inc.5b3bcc75-608d-23fd-91a5-0806d5fe32f52022-11-18Adverse reactionsExact identifier
application applno (ANDA): 089798
application number: ANDA089798
ndc (product): 0713-0225

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0713-0225Triamcinolone AcetonideTriamcinolone AcetonideCosette Pharmaceuticals, Inc.ANDACurrent
0713-0225Triamcinolone AcetonideTriamcinolone AcetonideCosette Pharmaceuticals, Inc.ANDACurrent
0713-0225Triamcinolone AcetonideTriamcinolone AcetonideCosette Pharmaceuticals, Inc.ANDACurrent
0713-0225Triamcinolone AcetonideTriamcinolone AcetonideCosette Pharmaceuticals, Inc.ANDACurrent
0713-0225Triamcinolone AcetonideTriamcinolone AcetonideG&W Laboratories, Inc.ANDACurrent
53002-9331Triamcinolone AcetonideTriamcinolone AcetonideRPK Pharmaceuticals, Inc.ANDACurrent
53002-9331Triamcinolone AcetonideTriamcinolone AcetonideRPK Pharmaceuticals, Inc.ANDACurrent
68071-4630Triamcinolone AcetonideTriamcinolone AcetonideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4630Triamcinolone AcetonideTriamcinolone AcetonideNuCare Pharmaceuticals,Inc.ANDACurrent