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 5 of 11 · 211 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join NASAL ALLERGY RELIEF TRIAMCINOLONE ACETONIDE Kroger Company 47d05350-26a8-4348-b506-078e0984fa87 2025-10-27 Warnings Name fallback generic name: TRIAMCINOLONE ACETONIDE Triamcinolone Acetonide TRIAMCINOLONE ACETONIDE Long Grove Pharmaceuticals, LLC 9e48eec7-7cd5-4174-8b3f-07c96f4ef115 2025-10-22 Warnings, Adverse reactions Name fallback brand name: Triamcinolone Acetonide generic name: TRIAMCINOLONE ACETONIDE Triamcinolone Acetonide TRIAMCINOLONE ACETONIDE Sun Pharmaceutical Industries, Inc. e7e16fc2-0222-44f5-925b-928d249f55cf 2025-10-15 Adverse reactions Name fallback brand name: Triamcinolone Acetonide generic name: TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE A-S Medication Solutions f65c5847-365e-44b0-a756-1b16788684db 2025-10-09 Adverse reactions Name fallback brand name: TRIAMCINOLONE ACETONIDE generic name: TRIAMCINOLONE ACETONIDE Xipere TRIAMCINOLONE ACETONIDE Bausch & Lomb Incorporated ea6ad429-967f-4f75-a33d-e06f849bee80 2025-10-08 Warnings, Adverse reactions Name fallback generic name: TRIAMCINOLONE ACETONIDE triamcinolone acetonide TRIAMCINOLONE ACETONIDE Preferred Pharmaceuticals Inc. 5701a07f-bd22-4bc7-95ff-0c5444ea5971 2025-10-01 Adverse reactions Name fallback brand name: triamcinolone acetonide generic name: TRIAMCINOLONE ACETONIDE Triamcinolone Acetonide TRIAMCINOLONE ACETONIDE Preferred Pharmaceuticals Inc 2548307e-8d36-4a63-862b-f2af7856104e 2025-10-01 Adverse reactions Name fallback brand name: Triamcinolone Acetonide generic name: TRIAMCINOLONE ACETONIDE Triamcinolone Acetonide TRIAMCINOLONE ACETONIDE Preferred Pharmaceuticals Inc adc16c6b-b508-48b8-af8c-a5f03f2955fe 2025-10-01 Adverse reactions Name fallback brand name: Triamcinolone Acetonide generic name: TRIAMCINOLONE ACETONIDE Triamcinolone Acetonide TRIAMCINOLONE ACETONIDE Preferred Pharmaceuticals, Inc. a1633e66-2ce8-42e4-8046-ac10dadfa34b 2025-10-01 Adverse reactions Name fallback brand name: Triamcinolone Acetonide generic name: TRIAMCINOLONE ACETONIDE Triamcinolone acetonide TRIAMCINOLONE ACETONIDE Preferred Pharmaceuticals Inc. 777c3cb9-da2b-431c-934f-f3c70f93d6cb 2025-10-01 Adverse reactions Name fallback brand name: Triamcinolone acetonide generic name: TRIAMCINOLONE ACETONIDE Triamcinolone Acetonide TRIAMCINOLONE ACETONIDE Preferred Pharmaceuticals Inc. 99f8a0e6-8ee8-4430-b1d5-1022da1d72ab 2025-10-01 Adverse reactions Name fallback brand name: Triamcinolone Acetonide generic name: TRIAMCINOLONE ACETONIDE Triamcinolone Acetonide TRIAMCINOLONE ACETONIDE OINTMENT USP, 0.05% Encube Ethicals, Inc. a20baaac-002d-40ac-9c7b-f92e8ee987ea 2025-09-25 Adverse reactions Name fallback brand name: Triamcinolone Acetonide Triamcinolone Acetonide TRIAMCINOLONE ACETONIDE Sun Pharmaceutical Industries, Inc. b353c8b1-9088-4969-8199-37876f2461cc 2025-09-15 Adverse reactions Name fallback brand name: Triamcinolone Acetonide generic name: TRIAMCINOLONE ACETONIDE Triamcinolone Acetonide TRIAMCINOLONE ACETONIDE ProPharma Distribution 3edd3ad8-2561-59b5-e063-6294a90a0165 2025-09-15 Warnings, Adverse reactions Name fallback brand name: Triamcinolone Acetonide generic name: TRIAMCINOLONE ACETONIDE Triamcinolone acetonide TRIAMCINOLONE ACETONIDE Allegiant Health 1fd76a49-61ee-4d4d-8abc-e666b2d3c5b0 2025-07-29 Warnings Name fallback brand name: Triamcinolone acetonide generic name: TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE Bryant Ranch Prepack d870041e-7c92-4f88-a305-ecb8f50a5773 2025-07-28 Adverse reactions Name fallback brand name: TRIAMCINOLONE ACETONIDE generic name: TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE Bryant Ranch Prepack d086c38e-99c7-4d25-a722-a61c77d3989b 2025-07-28 Adverse reactions Name fallback brand name: TRIAMCINOLONE ACETONIDE generic name: TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE QUAGEN PHARMACEUTICALS LLC 4c6ff738-60a3-4339-8e94-26fb9df65841 2025-07-22 Adverse reactions Name fallback brand name: TRIAMCINOLONE ACETONIDE generic name: TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE Preferred Pharmaceuticals Inc. d0428b54-c4f5-46f1-a65e-7e20c56dbe78 2025-07-10 Adverse reactions Name fallback brand name: TRIAMCINOLONE ACETONIDE generic name: TRIAMCINOLONE ACETONIDE Oralone TRIAMCINOLONE ACETONIDE Sun Pharmaceutical Industries, Inc. ac1e2116-795e-4c20-974d-11fa07cf0fa7 2025-07-07 Adverse reactions Name fallback 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