Home Applications 207365 Application 207365
Type ANDA
Sponsor NOVEL LABS INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE OINTMENT;TOPICAL 0.1% No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A207365-001 TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 2018-10-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A207365-001 AT
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 · 43 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A207365-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 2018-10-12 84e616aacf4f…2026-08-18 06:07:40 2026-07 A207365-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 2018-10-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A207365-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 2018-10-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207365-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 2018-10-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207365-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 2018-10-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207365-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 2018-10-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207365-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 2018-10-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207365-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 2018-10-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207365-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 2018-10-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207365-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 2018-10-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207365-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 2018-10-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207365-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 2018-10-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207365-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 2018-10-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207365-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 2018-10-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207365-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 2018-10-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207365-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 2018-10-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207365-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 2018-10-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A207365-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 2018-10-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A207365-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 2018-10-12 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A207365-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 2018-10-12 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A207365-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 2018-10-12 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A207365-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 2018-10-12 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A207365-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 2018-10-12 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A207365-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 2018-10-12 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A207365-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 2018-10-12 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A207365-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 2018-10-12 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A207365-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 2018-10-12 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A207365-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 2018-10-12 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A207365-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 2018-10-12 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A207365-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 2018-10-12 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A207365-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 2018-10-12 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A207365-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 2018-10-12 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A207365-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 2018-10-12 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A207365-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 2018-10-12 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A207365-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 2018-10-12 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A207365-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 2018-10-12 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A207365-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 2018-10-12 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A207365-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 2018-10-12 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A207365-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 2018-10-12 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A207365-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 2018-10-12 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
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 2 of 11 · 211 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE Encube Ethicals, Inc. 6a31a0c3-2b6e-40e3-b5ea-5c665afd3567 2026-07-06 Adverse reactions Name fallback brand name: TRIAMCINOLONE ACETONIDE generic name: TRIAMCINOLONE ACETONIDE Triamcinolone Acetonide TRIAMCINOLONE ACETONIDE A-S Medication Solutions 089a8449-7810-48ec-b327-494f058c3348 2026-06-22 Adverse reactions Name fallback brand name: Triamcinolone Acetonide generic name: TRIAMCINOLONE ACETONIDE Triamcinolone Acetonide TRIAMCINOLONE ACETONIDE Amneal Pharmaceuticals LLC 6b6eed06-ff96-4ceb-bb0c-a67a149987a4 2026-06-18 Warnings, Adverse reactions Name fallback brand name: Triamcinolone Acetonide generic name: TRIAMCINOLONE ACETONIDE Triamcinolone Acetonide TRIAMCINOLONE ACETONIDE Amneal Pharmaceuticals LLC bf0b4d32-c8b7-48c9-a29b-3e7c2afc6cbf 2026-06-17 Warnings, Adverse reactions Name fallback brand name: Triamcinolone Acetonide generic name: TRIAMCINOLONE ACETONIDE Triamcinolone Acetonide TRIAMCINOLONE ACETONIDE NorthStar Rx LLC 5f3aaf3a-cc66-4d4f-b9b7-2c50c325d477 2026-06-17 Warnings, Adverse reactions Name fallback brand name: Triamcinolone Acetonide generic name: TRIAMCINOLONE ACETONIDE 24 Hour Nasal Allergy TRIAMCINOLONE ACETONIDE Meijer Distribution Inc fcae02eb-454d-4752-8848-c0c590f1f529 2026-06-09 Warnings Name fallback generic name: TRIAMCINOLONE ACETONIDE Good Sense Nasal Allergy TRIAMCINOLONE ACETONIDE L. Perrigo Company 082c79e9-d6b2-40b8-baf9-2a91b9ecaea4 2026-06-08 Warnings Name fallback generic name: TRIAMCINOLONE ACETONIDE TRIESENCE TRIAMCINOLONE ACETONIDE Harrow Eye, LLC 2267978c-72ad-9229-e063-6394a90a09d0 2026-06-05 Warnings, Adverse reactions Name fallback generic name: TRIAMCINOLONE ACETONIDE Triamcinolone Acetonide TRIAMCINOLONE ACETONIDE CARDINAL HEALTH 110, LLC. DBA LEADER 70000 444ca70e-fa06-4808-bd9d-d53ee725b752 2026-05-21 Warnings Name fallback brand name: Triamcinolone Acetonide generic name: TRIAMCINOLONE ACETONIDE Nasal Allergy TRIAMCINOLONE ACETONIDE Rugby Laboratories 0ae25bc9-5d90-4dd8-9620-8684c4fd9d37 2026-05-21 Warnings Name fallback generic name: TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE Dr. Reddy's Laboratories Inc af498d0a-c2a4-da25-3636-a1b45628e9e7 2026-05-20 Warnings, Adverse reactions Name fallback brand name: TRIAMCINOLONE ACETONIDE generic name: TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE Dr. Reddy's Labortories Inc 8190195b-9847-d3d5-76a4-015cc24307e5 2026-05-20 Warnings, Adverse reactions Name fallback brand name: TRIAMCINOLONE ACETONIDE generic name: TRIAMCINOLONE ACETONIDE Triamcinolone Acetonide TRIAMCINOLONE ACETONIDE REMEDYREPACK INC. 484766b9-cec6-4379-b79d-398c921b32b2 2026-05-18 Adverse reactions Name fallback brand name: Triamcinolone Acetonide generic name: TRIAMCINOLONE ACETONIDE Triamcinolone Acetonide TRIAMCINOLONE ACETONIDE Sportpharm LLC cfae0704-e754-419b-bbdc-69e7867a8a5a 2026-05-07 Warnings, Adverse reactions Name fallback brand name: Triamcinolone Acetonide generic name: TRIAMCINOLONE ACETONIDE Triamcinolone Acetonide TRIAMCINOLONE ACETONIDE A-S Medication Solutions 6d565a2c-d145-425a-a87d-6d07a90ad2fe 2026-04-27 Adverse reactions Name fallback brand name: Triamcinolone Acetonide generic name: TRIAMCINOLONE ACETONIDE allergy relief TRIAMCINOLONE ACETONIDE CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED d2c36b17-d5ed-4f91-b3cc-15900e6b341d 2026-04-20 Warnings Name fallback generic name: TRIAMCINOLONE ACETONIDE Triamcinolone Acetonide TRIAMCINOLONE ACETONIDE REMEDYREPACK INC. 809c8ef7-6313-412e-82c7-adaa824bb599 2026-04-15 Adverse reactions Name fallback brand name: Triamcinolone Acetonide generic name: TRIAMCINOLONE ACETONIDE Triamcinolone acetonide TRIAMCINOLONE ACETONIDE Bryant Ranch Prepack 3fc24a96-91b0-46bd-bf16-b3d5739e9c07 2026-04-14 Adverse reactions Name fallback brand name: Triamcinolone acetonide generic name: TRIAMCINOLONE ACETONIDE Trilona TRIAMCINOLONE ACETONIDE Skya Health, LLC 00cb6cd0-da04-4c87-a60c-c891666a6574 2026-04-14 Adverse reactions Name fallback generic name: TRIAMCINOLONE ACETONIDE Triamcinolone Acetonide TRIAMCINOLONE ACETONIDE Direct_Rx 4d29394d-4725-f912-e063-6294a90a062c 2026-04-08 Adverse reactions Name fallback brand name: Triamcinolone Acetonide generic name: TRIAMCINOLONE ACETONIDE
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 1 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 40032-097 Triamcinolone Acetonide Triamcinolone Acetonide Novel Laboratories, Inc. ANDA Current