Home Applications 208763 Application 208763
Type ANDA
Sponsor LUPIN ATLANTIS 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 A208763-001 TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE 0.025% CREAM / TOPICAL AT 2017-02-01 A208763-002 TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE 0.1% CREAM / TOPICAL AT 2017-02-01 A208763-003 TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE 0.5% CREAM / TOPICAL AT 2017-02-01
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 A208763-001 TRIAMCINOLONE ACETONIDE 0.025% CREAM / TOPICAL AT 2017-02-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 A208763-002 TRIAMCINOLONE ACETONIDE 0.1% CREAM / TOPICAL AT 2017-02-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 A208763-003 TRIAMCINOLONE ACETONIDE 0.5% CREAM / TOPICAL AT 2017-02-01 84e616aacf4f…2026-08-18 06:07:40 2026-07 A208763-001 TRIAMCINOLONE ACETONIDE 0.025% CREAM / TOPICAL AT 2017-02-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208763-002 TRIAMCINOLONE ACETONIDE 0.1% CREAM / TOPICAL AT 2017-02-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208763-003 TRIAMCINOLONE ACETONIDE 0.5% CREAM / TOPICAL AT 2017-02-01 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A208763-001 TRIAMCINOLONE ACETONIDE 0.025% CREAM / TOPICAL AT 2017-02-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208763-002 TRIAMCINOLONE ACETONIDE 0.1% CREAM / TOPICAL AT 2017-02-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208763-003 TRIAMCINOLONE ACETONIDE 0.5% CREAM / TOPICAL AT 2017-02-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208763-001 TRIAMCINOLONE ACETONIDE 0.025% CREAM / TOPICAL AT 2017-02-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208763-002 TRIAMCINOLONE ACETONIDE 0.1% CREAM / TOPICAL AT 2017-02-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208763-003 TRIAMCINOLONE ACETONIDE 0.5% CREAM / TOPICAL AT 2017-02-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208763-001 TRIAMCINOLONE ACETONIDE 0.025% CREAM / TOPICAL AT 2017-02-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208763-002 TRIAMCINOLONE ACETONIDE 0.1% CREAM / TOPICAL AT 2017-02-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208763-003 TRIAMCINOLONE ACETONIDE 0.5% CREAM / TOPICAL AT 2017-02-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208763-001 TRIAMCINOLONE ACETONIDE 0.025% CREAM / TOPICAL AT 2017-02-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208763-002 TRIAMCINOLONE ACETONIDE 0.1% CREAM / TOPICAL AT 2017-02-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208763-003 TRIAMCINOLONE ACETONIDE 0.5% CREAM / TOPICAL AT 2017-02-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208763-001 TRIAMCINOLONE ACETONIDE 0.025% CREAM / TOPICAL AT 2017-02-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208763-002 TRIAMCINOLONE ACETONIDE 0.1% CREAM / TOPICAL AT 2017-02-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208763-003 TRIAMCINOLONE ACETONIDE 0.5% CREAM / TOPICAL AT 2017-02-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208763-001 TRIAMCINOLONE ACETONIDE 0.025% CREAM / TOPICAL AT 2017-02-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208763-002 TRIAMCINOLONE ACETONIDE 0.1% CREAM / TOPICAL AT 2017-02-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208763-003 TRIAMCINOLONE ACETONIDE 0.5% CREAM / TOPICAL AT 2017-02-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208763-001 TRIAMCINOLONE ACETONIDE 0.025% CREAM / TOPICAL AT 2017-02-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208763-002 TRIAMCINOLONE ACETONIDE 0.1% CREAM / TOPICAL AT 2017-02-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208763-003 TRIAMCINOLONE ACETONIDE 0.5% CREAM / TOPICAL AT 2017-02-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208763-001 TRIAMCINOLONE ACETONIDE 0.025% CREAM / TOPICAL AT 2017-02-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208763-002 TRIAMCINOLONE ACETONIDE 0.1% CREAM / TOPICAL AT 2017-02-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208763-003 TRIAMCINOLONE ACETONIDE 0.5% CREAM / TOPICAL AT 2017-02-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208763-001 TRIAMCINOLONE ACETONIDE 0.025% CREAM / TOPICAL AT 2017-02-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208763-002 TRIAMCINOLONE ACETONIDE 0.1% CREAM / TOPICAL AT 2017-02-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208763-003 TRIAMCINOLONE ACETONIDE 0.5% CREAM / TOPICAL AT 2017-02-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208763-001 TRIAMCINOLONE ACETONIDE 0.025% CREAM / TOPICAL AT 2017-02-01 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A208763-002 TRIAMCINOLONE ACETONIDE 0.1% CREAM / TOPICAL AT 2017-02-01 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A208763-003 TRIAMCINOLONE ACETONIDE 0.5% CREAM / TOPICAL AT 2017-02-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208763-001 TRIAMCINOLONE ACETONIDE 0.025% CREAM / TOPICAL AT 2017-02-01 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208763-002 TRIAMCINOLONE ACETONIDE 0.1% CREAM / TOPICAL AT 2017-02-01 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208763-003 TRIAMCINOLONE ACETONIDE 0.5% CREAM / TOPICAL AT 2017-02-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208763-001 TRIAMCINOLONE ACETONIDE 0.025% CREAM / TOPICAL AT 2017-02-01 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 4 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 E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC a5cc640f-c72d-49fa-b970-906c9ffd8629 2026-01-28 Adverse reactions Name fallback brand name: Triamcinolone Acetonide generic name: TRIAMCINOLONE ACETONIDE triamcinolone acetonide TRIAMCINOLONE ACETONIDE E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC 92a1ded0-8e1a-4994-9c8a-89e84fc85c94 2026-01-28 Adverse reactions Name fallback brand name: triamcinolone acetonide generic name: TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE REMEDYREPACK INC. d53c1728-6846-4e7d-a772-8b54ba9529b0 2026-01-26 Adverse reactions Name fallback brand name: TRIAMCINOLONE ACETONIDE generic name: TRIAMCINOLONE ACETONIDE Triamcinolone Acetonide TRIAMCINOLONE ACETONIDE ASCLEMED USA INC. b909659e-8dd5-4652-89f4-c4d6b741a855 2026-01-23 Warnings, Adverse reactions Name fallback brand name: Triamcinolone Acetonide generic name: TRIAMCINOLONE ACETONIDE Triamcinolone Acetonide TRIAMCINOLONE ACETONIDE NuCare Pharmaceuticals,Inc. 5439cd3c-da8d-3b96-e054-00144ff8d46c 2026-01-21 Adverse reactions Name fallback brand name: Triamcinolone Acetonide generic name: TRIAMCINOLONE ACETONIDE Triamcinolone acetonide TRIAMCINOLONE ACETONIDE REMEDYREPACK INC. 037efc03-22ab-45eb-9b0e-b125e4b5eb99 2026-01-20 Adverse reactions Name fallback brand name: Triamcinolone acetonide generic name: TRIAMCINOLONE ACETONIDE Triamcinolone Acetonide TRIAMCINOLONE ACETONIDE Sportpharm LLC cab0573d-e760-4ff5-a69f-0ce06cfdb97a 2026-01-19 Warnings, Adverse reactions Name fallback brand name: Triamcinolone Acetonide generic name: TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE Preferred Pharmaceuticals Inc. 60973042-077c-4265-988c-ad381f560333 2026-01-19 Adverse reactions Name fallback brand name: TRIAMCINOLONE ACETONIDE generic name: TRIAMCINOLONE ACETONIDE Nasacort Allergy 24HR TRIAMCINOLONE ACETONIDE Chattem, Inc. 4bff57a5-cce0-401c-a0fe-23c65c1b7ddc 2026-01-14 Warnings Name fallback generic name: TRIAMCINOLONE ACETONIDE Triamcinolone Acetonide TRIAMCINOLONE ACETONIDE A-S Medication Solutions 33793dfe-1214-4e0f-904c-771711ecb125 2026-01-14 Adverse reactions Name fallback brand name: Triamcinolone Acetonide generic name: TRIAMCINOLONE ACETONIDE TRIDERM TRIAMCINOLONE ACETONIDE Crown Laboratories 2c7fee2c-6f57-4de4-8803-98c0b31b07c3 2026-01-12 Adverse reactions Name fallback generic name: TRIAMCINOLONE ACETONIDE Triamcinolone Acetonide TRIAMCINOLONE ACETONIDE REMEDYREPACK INC. 570696d5-7c4e-4f89-b288-e3e09e3b32cc 2026-01-09 Adverse reactions Name fallback brand name: Triamcinolone Acetonide generic name: TRIAMCINOLONE ACETONIDE KENALOG-40 TRIAMCINOLONE ACETONIDE A-S Medication Solutions 4ce116aa-b330-4da9-9cdd-ba8e6be0c4ad 2026-01-05 Warnings, Adverse reactions Name fallback generic name: TRIAMCINOLONE ACETONIDE Triamcinolone Acetonide TRIAMCINOLONE ACETONIDE RedpharmDrug 2fc08cae-77e2-5e67-e063-6294a90aa593 2025-12-30 Adverse reactions Name fallback brand name: Triamcinolone Acetonide generic name: TRIAMCINOLONE ACETONIDE NASAL ALLERGY TRIAMCINOLONE ACETONIDE Safeway fe41d6c4-f1f4-4fec-adbc-85df460fdfc3 2025-12-06 Warnings Name fallback generic name: TRIAMCINOLONE ACETONIDE KENALOG-40 TRIAMCINOLONE ACETONIDE A-S Medication Solutions d26b97b8-edc8-4b93-b6b9-429016208ff9 2025-12-05 Warnings, Adverse reactions Name fallback generic name: TRIAMCINOLONE ACETONIDE Triamcinolone Acetonide TRIAMCINOLONE ACETONIDE A-S Medication Solutions fab09252-d474-4894-bbbf-a95b14c78936 2025-11-26 Adverse reactions Name fallback brand name: Triamcinolone Acetonide generic name: TRIAMCINOLONE ACETONIDE KOURZEQ TRIAMCINOLONE ACETONIDE MidAmerica Pharmaceuticals aad48d1e-f8db-4020-92af-0b3258bbc0f2 2025-11-18 Adverse reactions Name fallback generic name: TRIAMCINOLONE ACETONIDE Triamcinolone Acetonide TRIAMCINOLONE ACETONIDE Alembic Pharmaceuticals Inc. 05c2a9cf-a018-48c0-9c73-2d59d52211d2 2025-11-03 Warnings, Adverse reactions Name fallback brand name: Triamcinolone Acetonide generic name: TRIAMCINOLONE ACETONIDE Triamcinolone Acetonide TRIAMCINOLONE ACETONIDE Alembic Pharmaceuticals Limited c0b487dd-a47b-42fd-a855-5d237c5651a9 2025-11-03 Warnings, 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.