Home Applications 089595 Application 089595
Type ANDA
Sponsor CMP PHARMA INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TRIAMCINOLONE ACETONIDE IN ABSORBASE TRIAMCINOLONE ACETONIDE OINTMENT;TOPICAL 0.05% No Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A089595-001 TRIANEX TRIAMCINOLONE ACETONIDE 0.05% OINTMENT / TOPICAL 1995-03-23
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 · 42 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 2026-08-18 06:07:40 2026-07 A089595-001 TRIANEX 0.05% OINTMENT / TOPICAL 1995-03-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A089595-001 TRIANEX 0.05% OINTMENT / TOPICAL 1995-03-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A089595-001 TRIANEX 0.05% OINTMENT / TOPICAL 1995-03-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A089595-001 TRIANEX 0.05% OINTMENT / TOPICAL 1995-03-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A089595-001 TRIANEX 0.05% OINTMENT / TOPICAL 1995-03-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A089595-001 TRIANEX 0.05% OINTMENT / TOPICAL 1995-03-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A089595-001 TRIANEX 0.05% OINTMENT / TOPICAL 1995-03-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A089595-001 TRIANEX 0.05% OINTMENT / TOPICAL 1995-03-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A089595-001 TRIANEX 0.05% OINTMENT / TOPICAL 1995-03-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A089595-001 TRIANEX 0.05% OINTMENT / TOPICAL 1995-03-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A089595-001 TRIANEX 0.05% OINTMENT / TOPICAL 1995-03-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A089595-001 TRIANEX 0.05% OINTMENT / TOPICAL 1995-03-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A089595-001 TRIANEX 0.05% OINTMENT / TOPICAL 1995-03-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A089595-001 TRIANEX 0.05% OINTMENT / TOPICAL 1995-03-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A089595-001 TRIANEX 0.05% OINTMENT / TOPICAL 1995-03-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A089595-001 TRIANEX 0.05% OINTMENT / TOPICAL AT RS 1995-03-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A089595-001 TRIANEX 0.05% OINTMENT / TOPICAL AT RS 1995-03-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A089595-001 TRIANEX 0.05% OINTMENT / TOPICAL AT RS 1995-03-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A089595-001 TRIAMCINOLONE ACETONIDE IN ABSORBASE 0.05% OINTMENT / TOPICAL RS 1995-03-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A089595-001 TRIANEX 0.05% OINTMENT / TOPICAL AT RS 1995-03-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A089595-001 TRIANEX 0.05% OINTMENT / TOPICAL AT RS 1995-03-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A089595-001 TRIAMCINOLONE ACETONIDE IN ABSORBASE 0.05% OINTMENT / TOPICAL AT RS 1995-03-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A089595-001 TRIAMCINOLONE ACETONIDE IN ABSORBASE 0.05% OINTMENT / TOPICAL AT RS 1995-03-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A089595-001 TRIAMCINOLONE ACETONIDE IN ABSORBASE 0.05% OINTMENT / TOPICAL AT RS 1995-03-23 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A089595-001 TRIAMCINOLONE ACETONIDE IN ABSORBASE 0.05% OINTMENT / TOPICAL AT RS 1995-03-23 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A089595-001 TRIAMCINOLONE ACETONIDE IN ABSORBASE 0.05% OINTMENT / TOPICAL AT RS 1995-03-23 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A089595-001 TRIAMCINOLONE ACETONIDE IN ABSORBASE 0.05% OINTMENT / TOPICAL RS 1995-03-23 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A089595-001 TRIAMCINOLONE ACETONIDE IN ABSORBASE 0.05% OINTMENT / TOPICAL RS 1995-03-23 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A089595-001 TRIANEX 0.05% OINTMENT / TOPICAL 1995-03-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A089595-001 TRIANEX 0.05% OINTMENT / TOPICAL 1995-03-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A089595-001 TRIANEX 0.05% OINTMENT / TOPICAL 1995-03-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A089595-001 TRIANEX 0.05% OINTMENT / TOPICAL AT RS 1995-03-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A089595-001 TRIANEX 0.05% OINTMENT / TOPICAL AT RS 1995-03-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A089595-001 TRIANEX 0.05% OINTMENT / TOPICAL AT RS 1995-03-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A089595-001 TRIANEX 0.05% OINTMENT / TOPICAL AT RS 1995-03-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A089595-001 TRIANEX 0.05% OINTMENT / TOPICAL AT RS 1995-03-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A089595-001 TRIANEX 0.05% OINTMENT / TOPICAL AT RS 1995-03-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A089595-001 TRIANEX 0.05% OINTMENT / TOPICAL AT RS 1995-03-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A089595-001 TRIANEX 0.05% OINTMENT / TOPICAL AT RS 1995-03-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A089595-001 TRIANEX 0.05% OINTMENT / TOPICAL AT RS 1995-03-23 e64feba35796…
Observed Orange Book normalized TE history# 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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 4 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 46287-010 Triamcinolone Acetonide Triamcinolone Acetonide CMP Pharma, Inc. ANDA Current 67857-806 Trianex 0.05% Triamcinolone Acetonide Ointment Promius Pharma, LLC ANDA Current 67857-806 Trianex 0.05% Triamcinolone Acetonide Ointment Promius Pharma, LLC ANDA Current 73308-402 Triamcinolone Acetonide in Absorbase Triamcinolone Acetonide in Absorbase Ayurax, LLC ANDA Current