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 3 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 Bryant Ranch Prepack 6658728a-99d7-48c3-83d6-4e40c59c9b47 2026-04-07 Adverse reactions Name fallback brand name: Triamcinolone acetonide generic name: TRIAMCINOLONE ACETONIDE Allergy Nasal TRIAMCINOLONE ACETONIDE Walgreen Company a33aa2f3-9e9e-4408-b671-508c79a29c06 2026-04-07 Warnings Name fallback generic name: TRIAMCINOLONE ACETONIDE Triamcinolone Acetonide TRIAMCINOLONE ACETONIDE NuCare Pharmceuticals,Inc. 4e94fde1-ea31-e333-e063-6294a90a5107 2026-04-03 Adverse reactions Name fallback brand name: Triamcinolone Acetonide generic name: TRIAMCINOLONE ACETONIDE Triamcinolone acetonide TRIAMCINOLONE ACETONIDE A-S Medication Solutions 10cf5e2f-0e9f-4fc0-af4a-3be46a4af475 2026-04-02 Adverse reactions Name fallback brand name: Triamcinolone acetonide generic name: TRIAMCINOLONE ACETONIDE Triamcinolone Acetonide TRIAMCINOLONE ACETONIDE Sportpharm LLC 8d11aee3-b66e-439b-9188-7d91219a59cf 2026-04-01 Warnings, Adverse reactions Name fallback brand name: Triamcinolone Acetonide generic name: TRIAMCINOLONE ACETONIDE TRIESENCE TRIAMCINOLONE ACETONIDE Novartis Pharmaceuticals Corporation 22692d92-1359-9252-e063-6394a90ab669 2026-04-01 Warnings, Adverse reactions Name fallback generic name: TRIAMCINOLONE ACETONIDE Triamcinolone Acetonide TRIAMCINOLONE ACETONIDE Direct_rx 4e400049-c763-56f7-e063-6294a90a6fd7 2026-03-30 Adverse reactions Name fallback brand name: Triamcinolone Acetonide generic name: TRIAMCINOLONE ACETONIDE Triamcinolone Acetonide TRIAMCINOLONE ACETONIDE Bryant Ranch Prepack 0844a8f0-116d-40f6-8462-cccd6bcefc8a 2026-03-27 Adverse reactions Name fallback brand name: Triamcinolone Acetonide generic name: TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE DIRECTRX 835bbcd1-3869-646c-e053-2a91aa0a796a 2026-03-17 Adverse reactions Name fallback brand name: TRIAMCINOLONE ACETONIDE generic name: TRIAMCINOLONE ACETONIDE Triamcinolone Acetonide TRIAMCINOLONE ACETONIDE Direct_rx 20ac5621-cd18-a7dd-e063-6394a90a99fa 2026-03-17 Adverse reactions Name fallback brand name: Triamcinolone Acetonide generic name: TRIAMCINOLONE ACETONIDE Triamcinolone Acetonide TRIAMCINOLONE ACETONIDE Asclemed USA, Inc. b20c22b2-9a74-4b71-9015-40838fd2d193 2026-03-10 Adverse reactions Name fallback brand name: Triamcinolone Acetonide generic name: TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE Direct_Rx 93de78fb-1f19-cfc6-e053-2995a90a9bc7 2026-03-05 Adverse reactions Name fallback brand name: TRIAMCINOLONE ACETONIDE generic name: TRIAMCINOLONE ACETONIDE Triamcinolone acetonide TRIAMCINOLONE ACETONIDE NuCare Pharmaceuticals,Inc. bd45c7d2-a1a3-e0f5-e053-2a95a90ae4b3 2026-02-19 Adverse reactions Name fallback brand name: Triamcinolone acetonide generic name: TRIAMCINOLONE ACETONIDE Triamcinolone acetonide TRIAMCINOLONE ACETONIDE NuCare Pharmaceuticals,Inc. bd465674-3527-1590-e053-2995a90a958d 2026-02-19 Adverse reactions Name fallback brand name: Triamcinolone acetonide generic name: TRIAMCINOLONE ACETONIDE Triamcinolone acetonide TRIAMCINOLONE ACETONIDE A-S Medication Solutions 96f18791-480d-49f2-aac6-387321ae552c 2026-02-14 Adverse reactions Name fallback brand name: Triamcinolone acetonide generic name: TRIAMCINOLONE ACETONIDE Triamcinolone Acetonide TRIAMCINOLONE ACETONIDE Amneal Pharmaceuticals LLC c38dcd37-9840-4f71-a5c9-97380c8107f2 2026-02-12 Warnings, Adverse reactions Name fallback brand name: Triamcinolone Acetonide generic name: TRIAMCINOLONE ACETONIDE Triamcinolone acetonide TRIAMCINOLONE ACETONIDE A-S Medication Solutions 51fedf94-d94e-42b7-8e9f-e0e9b6bbd055 2026-02-11 Adverse reactions Name fallback brand name: Triamcinolone acetonide generic name: TRIAMCINOLONE ACETONIDE Triamcinolone Acetonide TRIAMCINOLONE ACETONIDE Sportpharm LLC 4e0ddecf-7ea1-4f42-9924-53fe5a5657ff 2026-02-10 Warnings, Adverse reactions Name fallback brand name: Triamcinolone Acetonide generic name: TRIAMCINOLONE ACETONIDE Triamcinolone Acetonide TRIAMCINOLONE ACETONIDE ASCLEMED USA INC. 1c6a740e-bc0d-41f3-b576-7d4c3880be23 2026-02-10 Warnings, Adverse reactions Name fallback brand name: Triamcinolone Acetonide generic name: TRIAMCINOLONE ACETONIDE Triamcinolone Acetonide TRIAMCINOLONE ACETONIDE REMEDYREPACK INC. c76d68dc-78e6-407c-ba9d-5d1c5d13509e 2026-02-05 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