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 1 of 11 · 212 matching rows.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.