Application 204608

Type
ANDA
Sponsor
TELIGENT PHARMA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDELOTION;TOPICAL0.025%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
A204608-001TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDE0.025%LOTION / TOPICAL2016-07-07

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 UTC2026-02A204608-001TRIAMCINOLONE ACETONIDE0.025%LOTION / TOPICAL2016-07-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204608-001TRIAMCINOLONE ACETONIDE0.025%LOTION / TOPICAL2016-07-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A204608-001TRIAMCINOLONE ACETONIDE0.025%LOTION / TOPICAL2016-07-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204608-001TRIAMCINOLONE ACETONIDE0.025%LOTION / TOPICAL2016-07-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204608-001TRIAMCINOLONE ACETONIDE0.025%LOTION / TOPICAL2016-07-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204608-001TRIAMCINOLONE ACETONIDE0.025%LOTION / TOPICAL2016-07-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204608-001TRIAMCINOLONE ACETONIDE0.025%LOTION / TOPICAL2016-07-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204608-001TRIAMCINOLONE ACETONIDE0.025%LOTION / TOPICAL2016-07-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204608-001TRIAMCINOLONE ACETONIDE0.025%LOTION / TOPICAL2016-07-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204608-001TRIAMCINOLONE ACETONIDE0.025%LOTION / TOPICAL2016-07-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204608-001TRIAMCINOLONE ACETONIDE0.025%LOTION / TOPICAL2016-07-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204608-001TRIAMCINOLONE ACETONIDE0.025%LOTION / TOPICAL2016-07-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204608-001TRIAMCINOLONE ACETONIDE0.025%LOTION / TOPICAL2016-07-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204608-001TRIAMCINOLONE ACETONIDE0.025%LOTION / TOPICAL2016-07-078072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204608-001TRIAMCINOLONE ACETONIDE0.025%LOTION / TOPICALAT2016-07-075c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A204608-001TRIAMCINOLONE ACETONIDE0.025%LOTION / TOPICALAT2016-07-075d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A204608-001TRIAMCINOLONE ACETONIDE0.025%LOTION / TOPICALAT2016-07-074b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A204608-001TRIAMCINOLONE ACETONIDE0.025%LOTION / TOPICALAT2016-07-0774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A204608-001TRIAMCINOLONE ACETONIDE0.025%LOTION / TOPICALAT2016-07-07bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A204608-001TRIAMCINOLONE ACETONIDE0.025%LOTION / TOPICALAT2016-07-07782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A204608-001TRIAMCINOLONE ACETONIDE0.025%LOTION / TOPICALAT2016-07-0787673890dc5c…
2021-03-12 10:30 UTC2021-03A204608-001TRIAMCINOLONE ACETONIDE0.025%LOTION / TOPICALAT2016-07-075aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A204608-001TRIAMCINOLONE ACETONIDE0.025%LOTION / TOPICALAT2016-07-078869cabd3fbd…
2020-11-12 02:37 UTC2020-11A204608-001TRIAMCINOLONE ACETONIDE0.025%LOTION / TOPICALAT2016-07-07c0c555d07b60…
2019-12-14 00:12 UTC2019-12A204608-001TRIAMCINOLONE ACETONIDE0.025%LOTION / TOPICALAT2016-07-073f01610625f2…
2019-09-15 20:21 UTC2019-09A204608-001TRIAMCINOLONE ACETONIDE0.025%LOTION / TOPICALAT2016-07-07b00525d2431f…
2019-07-19 19:46 UTC2019-07A204608-001TRIAMCINOLONE ACETONIDE0.025%LOTION / TOPICALAT2016-07-07ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A204608-001TRIAMCINOLONE ACETONIDE0.025%LOTION / TOPICAL2016-07-076a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A204608-001TRIAMCINOLONE ACETONIDE0.025%LOTION / TOPICAL2016-07-071c564ffb4f44…
2023-12-20 04:57 UTC2023-12A204608-001TRIAMCINOLONE ACETONIDE0.025%LOTION / TOPICAL2016-07-07ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A204608-001TRIAMCINOLONE ACETONIDE0.025%LOTION / TOPICAL2016-07-07a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A204608-001TRIAMCINOLONE ACETONIDE0.025%LOTION / TOPICAL2016-07-079b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A204608-001TRIAMCINOLONE ACETONIDE0.025%LOTION / TOPICALAT2016-07-07a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A204608-001TRIAMCINOLONE ACETONIDE0.025%LOTION / TOPICALAT2016-07-073f0d92c62455…
2023-05-13 08:27 UTC2023-05A204608-001TRIAMCINOLONE ACETONIDE0.025%LOTION / TOPICALAT2016-07-07053a50430f4f…
2023-01-26 05:58 UTC2023-01A204608-001TRIAMCINOLONE ACETONIDE0.025%LOTION / TOPICALAT2016-07-073bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A204608-001TRIAMCINOLONE ACETONIDE0.025%LOTION / TOPICALAT2016-07-073a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A204608-001TRIAMCINOLONE ACETONIDE0.025%LOTION / TOPICALAT2016-07-07f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A204608-001TRIAMCINOLONE ACETONIDE0.025%LOTION / TOPICALAT2016-07-07e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A204608-001TRIAMCINOLONE ACETONIDE0.025%LOTION / TOPICALAT2016-07-07cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204608-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A204608-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A204608-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A204608-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A204608-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A204608-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A204608-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A204608-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A204608-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A204608-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A204608-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A204608-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A204608-001AT1ea99ee380514…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A204608-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A204608-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05A204608-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01A204608-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A204608-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A204608-001AT1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A204608-001AT1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A204608-001AT1cb3db0bc1861…

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 11 · 213 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
KENALOG-10TRIAMCINOLONE ACETONIDEA-S Medication Solutions653ec195-0966-478d-be47-6b1ff158e1112026-07-30Warnings, Adverse reactionsName fallback
generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEPreferred Pharmaceuticals Inc.3d495acf-8085-4aaa-8fc5-594b88c25c212026-07-13Adverse reactionsName fallback
brand name: Triamcinolone Acetonide
generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDESportpharm LLC20c1234b-6749-422d-9420-9d5a98f5f30a2026-07-13Adverse reactionsName fallback
brand name: Triamcinolone Acetonide
generic name: TRIAMCINOLONE ACETONIDE
TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDEAscend Laboratories, LLCccca8660-124e-4220-8d87-4b9aeecbda7d2026-07-13Adverse reactionsName fallback
brand name: TRIAMCINOLONE ACETONIDE
generic name: TRIAMCINOLONE ACETONIDE
TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDEEncube Ethicals, Inc.db87426f-124c-4ea9-bb15-fc3a0da10a4e2026-07-07Adverse reactionsName fallback
brand name: TRIAMCINOLONE ACETONIDE
generic name: TRIAMCINOLONE ACETONIDE
TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDEEncube Ethicals, Inc.6a31a0c3-2b6e-40e3-b5ea-5c665afd35672026-07-06Adverse reactionsName fallback
brand name: TRIAMCINOLONE ACETONIDE
generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEA-S Medication Solutions089a8449-7810-48ec-b327-494f058c33482026-06-22Adverse reactionsName fallback
brand name: Triamcinolone Acetonide
generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEAmneal Pharmaceuticals LLC6b6eed06-ff96-4ceb-bb0c-a67a149987a42026-06-18Warnings, Adverse reactionsName fallback
brand name: Triamcinolone Acetonide
generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEAmneal Pharmaceuticals LLCbf0b4d32-c8b7-48c9-a29b-3e7c2afc6cbf2026-06-17Warnings, Adverse reactionsName fallback
brand name: Triamcinolone Acetonide
generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDENorthStar Rx LLC5f3aaf3a-cc66-4d4f-b9b7-2c50c325d4772026-06-17Warnings, Adverse reactionsName fallback
brand name: Triamcinolone Acetonide
generic name: TRIAMCINOLONE ACETONIDE
24 Hour Nasal AllergyTRIAMCINOLONE ACETONIDEMeijer Distribution Incfcae02eb-454d-4752-8848-c0c590f1f5292026-06-09WarningsName fallback
generic name: TRIAMCINOLONE ACETONIDE
Good Sense Nasal AllergyTRIAMCINOLONE ACETONIDEL. Perrigo Company082c79e9-d6b2-40b8-baf9-2a91b9ecaea42026-06-08WarningsName fallback
generic name: TRIAMCINOLONE ACETONIDE
TRIESENCETRIAMCINOLONE ACETONIDEHarrow Eye, LLC2267978c-72ad-9229-e063-6394a90a09d02026-06-05Warnings, Adverse reactionsName fallback
generic name: TRIAMCINOLONE ACETONIDE
TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDEBryant Ranch Prepackb2ba93bc-3775-466b-8daf-4ffa3edc9c002026-05-28Adverse reactionsName fallback
brand name: TRIAMCINOLONE ACETONIDE
generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDECARDINAL HEALTH 110, LLC. DBA LEADER 70000444ca70e-fa06-4808-bd9d-d53ee725b7522026-05-21WarningsName fallback
brand name: Triamcinolone Acetonide
generic name: TRIAMCINOLONE ACETONIDE
Nasal AllergyTRIAMCINOLONE ACETONIDERugby Laboratories0ae25bc9-5d90-4dd8-9620-8684c4fd9d372026-05-21WarningsName fallback
generic name: TRIAMCINOLONE ACETONIDE
TriadermexTRIAMCINOLONE ACETONIDEFlorrax Pharmaceutical3bda5cd1-df3c-4b4c-9868-cbc41f66f5a62026-05-21Adverse reactionsName fallback
generic name: TRIAMCINOLONE ACETONIDE
TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDEDr. Reddy's Laboratories Incaf498d0a-c2a4-da25-3636-a1b45628e9e72026-05-20Warnings, Adverse reactionsName fallback
brand name: TRIAMCINOLONE ACETONIDE
generic name: TRIAMCINOLONE ACETONIDE
TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDEDr. Reddy's Labortories Inc8190195b-9847-d3d5-76a4-015cc24307e52026-05-20Warnings, Adverse reactionsName fallback
brand name: TRIAMCINOLONE ACETONIDE
generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEREMEDYREPACK INC.484766b9-cec6-4379-b79d-398c921b32b22026-05-18Adverse reactionsName fallback
brand name: Triamcinolone Acetonide
generic name: TRIAMCINOLONE ACETONIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
52565-010Triamcinolone Acetonidetriamcinolone acetonideTeligent Pharma, Inc.ANDACurrent
52565-010Triamcinolone Acetonidetriamcinolone acetonideTeligent Pharma, Inc.ANDACurrent
52565-010Triamcinolone Acetonidetriamcinolone acetonideTeligent Pharma, Inc.ANDACurrent