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 6 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 Sun Pharmaceutical Industries, Inc. 6b4a9a08-f436-4f33-a940-a97c727788f9 2025-07-03 Adverse reactions Name fallback brand name: Triamcinolone Acetonide generic name: TRIAMCINOLONE ACETONIDE triamcinolone acetonide TRIAMCINOLONE ACETONIDE Preferred Pharmaceuticals Inc. 5040eba2-2d00-496a-8773-66ba5440610f 2025-06-27 Adverse reactions Name fallback brand name: triamcinolone acetonide generic name: TRIAMCINOLONE ACETONIDE Triamcinolone Acetonide TRIAMCINOLONE ACETONIDE NuCare Pharmaceuticals, Inc. 3597dccf-079c-5cd9-e063-6294a90aca71 2025-05-20 Adverse reactions Name fallback brand name: Triamcinolone Acetonide generic name: TRIAMCINOLONE ACETONIDE Triamcinolone Acetonide TRIAMCINOLONE ACETONIDE Asclemed USA, Inc. 915b93be-425f-41b5-a9b0-5831b7e040a5 2025-05-16 Adverse reactions Name fallback brand name: Triamcinolone Acetonide generic name: TRIAMCINOLONE ACETONIDE Triamcinolone Acetonide TRIAMCINOLONE ACETONIDE A-S Medication Solutions da474ee7-ac67-4e62-991d-ca979f13dea2 2025-05-15 Adverse reactions Name fallback brand name: Triamcinolone Acetonide generic name: TRIAMCINOLONE ACETONIDE Up and Up Nasal Allergy TRIAMCINOLONE ACETONIDE Target Corporation 492852c5-39eb-477f-9045-aaf50cf3306e 2025-04-29 Warnings Name fallback generic name: TRIAMCINOLONE ACETONIDE NASACORT TRIAMCINOLONE ACETONIDE A-S Medication Solutions 37f290c9-576d-463f-b7d4-a146f53855b0 2025-04-23 Warnings Name fallback generic name: TRIAMCINOLONE ACETONIDE Triamcinolone Acetonide TRIAMCINOLONE ACETONIDE Eugia US LLC d9abdda5-80e3-407c-b636-9cc5fc438098 2025-04-15 Warnings, Adverse reactions Name fallback brand name: Triamcinolone Acetonide generic name: TRIAMCINOLONE ACETONIDE Triamcinolone Acetonide TRIAMCINOLONE ACETONIDE Rising Pharma Holdings, Inc. 15ab1090-47d1-4925-8362-d7dda6fe74a9 2025-04-11 Adverse reactions Name fallback brand name: Triamcinolone Acetonide generic name: TRIAMCINOLONE ACETONIDE Triamcinolone acetonide TRIAMCINOLONE ACETONIDE NorthStar RxLLC 3379f247-4a29-4373-9843-0b7f044c2276 2025-04-03 Adverse reactions Name fallback brand name: Triamcinolone acetonide generic name: TRIAMCINOLONE ACETONIDE Triamcinolone Acetonide TRIAMCINOLONE ACETONIDE Preferred Pharmaceuticals Inc. da5652f8-585c-4697-bc65-2a613cb0ef0f 2025-03-20 Adverse reactions Name fallback brand name: Triamcinolone Acetonide generic name: TRIAMCINOLONE ACETONIDE Triamcinolone Acetonide TRIAMCINOLONE ACETONIDE NuCare Pharmaceuticals, Inc. 30b89788-4d90-617e-e063-6394a90a29dd 2025-03-19 Adverse reactions Name fallback brand name: Triamcinolone Acetonide generic name: TRIAMCINOLONE ACETONIDE Triamcinolone Acetonide TRIAMCINOLONE ACETONIDE Saptalis Pharmaceuticals, LLC. 8cbde037-da83-4390-8465-7e383eee9287 2025-03-03 Adverse reactions Name fallback brand name: Triamcinolone Acetonide generic name: TRIAMCINOLONE ACETONIDE Triamcinolone Acetonide TRIAMCINOLONE ACETONIDE NuCare Pharmaceuticals,Inc. 696cd64f-28dd-3dae-e053-2a91aa0a0c76 2025-02-13 Adverse reactions Name fallback brand name: Triamcinolone Acetonide generic name: TRIAMCINOLONE ACETONIDE Triamcinolone Acetonide TRIAMCINOLONE ACETONIDE Hikma Pharmaceuticals USA Inc. c940a2d5-09a5-413b-b5a1-d8da8907bafd 2025-01-29 Warnings, Adverse reactions Name fallback brand name: Triamcinolone Acetonide generic name: TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE CREAM Direct Rx d92e9eaf-3a79-76d7-e053-2995a90ae28d 2025-01-21 Adverse reactions Name fallback brand name: TRIAMCINOLONE ACETONIDE Triamcinolone Acetonide TRIAMCINOLONE ACETONIDE Preferred Pharmaceuticals Inc df6f5944-ba12-4731-9749-9095b3570dd3 2025-01-16 Adverse reactions Name fallback brand name: Triamcinolone Acetonide generic name: TRIAMCINOLONE ACETONIDE Good Neighbor Pharmacy 24 Hour Nasal Allergy TRIAMCINOLONE ACETONIDE Amerisource Bergen cccf50ee-60e1-44a1-a353-5949e8f85c0a 2025-01-04 Warnings Name fallback generic name: TRIAMCINOLONE ACETONIDE Triamcinolone acetonide TRIAMCINOLONE ACETONIDE Advanced Rx Pharmacy of Tennessee, LLC f4c077f2-2609-2235-e053-2995a90a1b57 2024-12-31 Warnings, Adverse reactions Name fallback brand name: Triamcinolone acetonide generic name: TRIAMCINOLONE ACETONIDE Triamcinolone Acetonide TRIAMCINOLONE ACETONIDE Padagis Israel Pharmaceuticals Ltd 5d2fe6c2-3856-47f6-843f-077b2e1080a0 2024-12-31 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.