Home Applications 207651 Application 207651
Type ANDA
Sponsor ALKEM LABS LTD Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE CREAM;TOPICAL 0.025% No No 002 TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE CREAM;TOPICAL 0.1% No No 003 TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE CREAM;TOPICAL 0.5% No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A207651-001 TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE 0.025% CREAM / TOPICAL AT 2017-12-26 A207651-002 TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE 0.1% CREAM / TOPICAL AT 2017-12-26 A207651-003 TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE 0.5% CREAM / TOPICAL AT 2017-12-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 4 · 129 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 A207651-001 TRIAMCINOLONE ACETONIDE 0.025% CREAM / TOPICAL AT 2017-12-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 A207651-002 TRIAMCINOLONE ACETONIDE 0.1% CREAM / TOPICAL AT 2017-12-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 A207651-003 TRIAMCINOLONE ACETONIDE 0.5% CREAM / TOPICAL AT 2017-12-26 84e616aacf4f…2026-08-18 06:07:40 2026-07 A207651-001 TRIAMCINOLONE ACETONIDE 0.025% CREAM / TOPICAL AT 2017-12-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207651-002 TRIAMCINOLONE ACETONIDE 0.1% CREAM / TOPICAL AT 2017-12-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207651-003 TRIAMCINOLONE ACETONIDE 0.5% CREAM / TOPICAL AT 2017-12-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A207651-001 TRIAMCINOLONE ACETONIDE 0.025% CREAM / TOPICAL AT 2017-12-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207651-002 TRIAMCINOLONE ACETONIDE 0.1% CREAM / TOPICAL AT 2017-12-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207651-003 TRIAMCINOLONE ACETONIDE 0.5% CREAM / TOPICAL AT 2017-12-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207651-001 TRIAMCINOLONE ACETONIDE 0.025% CREAM / TOPICAL AT 2017-12-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207651-002 TRIAMCINOLONE ACETONIDE 0.1% CREAM / TOPICAL AT 2017-12-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207651-003 TRIAMCINOLONE ACETONIDE 0.5% CREAM / TOPICAL AT 2017-12-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207651-001 TRIAMCINOLONE ACETONIDE 0.025% CREAM / TOPICAL AT 2017-12-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207651-002 TRIAMCINOLONE ACETONIDE 0.1% CREAM / TOPICAL AT 2017-12-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207651-003 TRIAMCINOLONE ACETONIDE 0.5% CREAM / TOPICAL AT 2017-12-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207651-001 TRIAMCINOLONE ACETONIDE 0.025% CREAM / TOPICAL AT 2017-12-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207651-002 TRIAMCINOLONE ACETONIDE 0.1% CREAM / TOPICAL AT 2017-12-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207651-003 TRIAMCINOLONE ACETONIDE 0.5% CREAM / TOPICAL AT 2017-12-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207651-001 TRIAMCINOLONE ACETONIDE 0.025% CREAM / TOPICAL AT 2017-12-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207651-002 TRIAMCINOLONE ACETONIDE 0.1% CREAM / TOPICAL AT 2017-12-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207651-003 TRIAMCINOLONE ACETONIDE 0.5% CREAM / TOPICAL AT 2017-12-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207651-001 TRIAMCINOLONE ACETONIDE 0.025% CREAM / TOPICAL AT 2017-12-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207651-002 TRIAMCINOLONE ACETONIDE 0.1% CREAM / TOPICAL AT 2017-12-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207651-003 TRIAMCINOLONE ACETONIDE 0.5% CREAM / TOPICAL AT 2017-12-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207651-001 TRIAMCINOLONE ACETONIDE 0.025% CREAM / TOPICAL AT 2017-12-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207651-002 TRIAMCINOLONE ACETONIDE 0.1% CREAM / TOPICAL AT 2017-12-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207651-003 TRIAMCINOLONE ACETONIDE 0.5% CREAM / TOPICAL AT 2017-12-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207651-001 TRIAMCINOLONE ACETONIDE 0.025% CREAM / TOPICAL AT 2017-12-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207651-002 TRIAMCINOLONE ACETONIDE 0.1% CREAM / TOPICAL AT 2017-12-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207651-003 TRIAMCINOLONE ACETONIDE 0.5% CREAM / TOPICAL AT 2017-12-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207651-001 TRIAMCINOLONE ACETONIDE 0.025% CREAM / TOPICAL AT 2017-12-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207651-002 TRIAMCINOLONE ACETONIDE 0.1% CREAM / TOPICAL AT 2017-12-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207651-003 TRIAMCINOLONE ACETONIDE 0.5% CREAM / TOPICAL AT 2017-12-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207651-001 TRIAMCINOLONE ACETONIDE 0.025% CREAM / TOPICAL AT 2017-12-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A207651-002 TRIAMCINOLONE ACETONIDE 0.1% CREAM / TOPICAL AT 2017-12-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A207651-003 TRIAMCINOLONE ACETONIDE 0.5% CREAM / TOPICAL AT 2017-12-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207651-001 TRIAMCINOLONE ACETONIDE 0.025% CREAM / TOPICAL AT 2017-12-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207651-002 TRIAMCINOLONE ACETONIDE 0.1% CREAM / TOPICAL AT 2017-12-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207651-003 TRIAMCINOLONE ACETONIDE 0.5% CREAM / TOPICAL AT 2017-12-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207651-001 TRIAMCINOLONE ACETONIDE 0.025% CREAM / TOPICAL AT 2017-12-26 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 129 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 11 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 Proficient Rx LP c91aaf91-afd9-4f0a-9634-6ed83763aa7c 2022-06-01 Adverse reactions Name fallback brand name: Triamcinolone Acetonide generic name: TRIAMCINOLONE ACETONIDE Triloan SUIK TRIAMCINOLONE ACETONIDE Asclemed USA, Inc. 320f7f0c-177c-42dc-96e6-4d688677c57a 2022-05-20 Warnings, Adverse reactions Name fallback generic name: TRIAMCINOLONE ACETONIDE Triamcinolone Acetonide TRIAMCINOLONE ACETONIDE Proficient Rx LP 63b51d50-7eb9-4687-965c-d4c57afc4030 2022-04-01 Adverse reactions Name fallback brand name: Triamcinolone Acetonide generic name: TRIAMCINOLONE ACETONIDE Triamcinolone Acetonide TRIAMCINOLONE ACETONIDE Asclemed USA, Inc. 1edfc7c0-616c-475e-bcde-49270765f710 2021-11-30 Adverse reactions Name fallback brand name: Triamcinolone Acetonide generic name: TRIAMCINOLONE ACETONIDE Triamcinolone Acetonide TRIAMCINOLONE ACETONIDE Strides Pharma Science Limited cfd1f3bd-0284-443b-8bdf-3e44f1f9bc82 2021-06-23 Adverse reactions Name fallback brand name: Triamcinolone Acetonide generic name: TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE Cintex Services, LLC be0270a4-5596-499e-aea2-8e63b3edc852 2020-11-20 Adverse reactions Name fallback brand name: TRIAMCINOLONE ACETONIDE generic name: TRIAMCINOLONE ACETONIDE Triamcinolone Acetonide TRIAMCINOLONE ACETONIDE Proficient Rx LP e5e3a38d-717d-4412-80d3-7130100add0a 2020-09-01 Adverse reactions Name fallback brand name: Triamcinolone Acetonide generic name: TRIAMCINOLONE ACETONIDE KENALOG-40 TRIAMCINOLONE ACETONIDE Asclemed USA, Inc. 0bc9c75f-963c-40b0-995b-dfcbd50371a5 2020-05-06 Warnings, Adverse reactions Name fallback generic name: TRIAMCINOLONE ACETONIDE Triamcinolone Acetonide TRIAMCINOLONE ACETONIDE Proficient Rx LP 41c1fe93-0509-4cf6-ac35-049028b731de 2019-12-01 Adverse reactions Name fallback brand name: Triamcinolone Acetonide generic name: TRIAMCINOLONE ACETONIDE Triamcinolone Acetonide TRIAMCINOLONE ACETONIDE Glenmark Pharmaceuticals Inc., USA 8c380328-127b-4ca6-bf56-ef461e704471 2017-08-22 Adverse reactions Name fallback brand name: Triamcinolone Acetonide generic name: TRIAMCINOLONE ACETONIDE Triamcinolone Acetonide TRIAMCINOLONE ACETONIDE Glenmark Pharmaceuticals Inc., USA a9b3764d-fd3d-4fcc-8d22-5aa848da1b06 2016-07-11 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 · 6 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 67877-470 TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE Ascend Laboratories, LLC ANDA Current 67877-470 TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE Ascend Laboratories, LLC ANDA Current 67877-471 TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE Ascend Laboratories, LLC ANDA Current 67877-471 TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE Ascend Laboratories, LLC ANDA Current 67877-472 TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE Ascend Laboratories, LLC ANDA Current 67877-472 TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE Ascend Laboratories, LLC ANDA Current