Home Applications 209535 Application 209535
Type ANDA
Sponsor MACLEODS PHARMS 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 1 .
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 A209535-001 TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE 0.025% CREAM / TOPICAL AT 2018-05-18 A209535-002 TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE 0.1% CREAM / TOPICAL AT 2018-05-18 A209535-003 TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE 0.5% CREAM / TOPICAL AT 2018-05-18
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 · 123 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 2026-02-19 14:30 UTC 2026-02 A209535-001 TRIAMCINOLONE ACETONIDE 0.025% CREAM / TOPICAL AT 2018-05-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209535-002 TRIAMCINOLONE ACETONIDE 0.1% CREAM / TOPICAL AT 2018-05-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209535-003 TRIAMCINOLONE ACETONIDE 0.5% CREAM / TOPICAL AT 2018-05-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209535-001 TRIAMCINOLONE ACETONIDE 0.025% CREAM / TOPICAL AT 2018-05-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209535-002 TRIAMCINOLONE ACETONIDE 0.1% CREAM / TOPICAL AT 2018-05-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209535-003 TRIAMCINOLONE ACETONIDE 0.5% CREAM / TOPICAL AT 2018-05-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209535-001 TRIAMCINOLONE ACETONIDE 0.025% CREAM / TOPICAL AT 2018-05-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209535-002 TRIAMCINOLONE ACETONIDE 0.1% CREAM / TOPICAL AT 2018-05-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209535-003 TRIAMCINOLONE ACETONIDE 0.5% CREAM / TOPICAL AT 2018-05-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209535-001 TRIAMCINOLONE ACETONIDE 0.025% CREAM / TOPICAL AT 2018-05-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209535-002 TRIAMCINOLONE ACETONIDE 0.1% CREAM / TOPICAL AT 2018-05-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209535-003 TRIAMCINOLONE ACETONIDE 0.5% CREAM / TOPICAL AT 2018-05-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209535-001 TRIAMCINOLONE ACETONIDE 0.025% CREAM / TOPICAL AT 2018-05-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209535-002 TRIAMCINOLONE ACETONIDE 0.1% CREAM / TOPICAL AT 2018-05-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209535-003 TRIAMCINOLONE ACETONIDE 0.5% CREAM / TOPICAL AT 2018-05-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209535-001 TRIAMCINOLONE ACETONIDE 0.025% CREAM / TOPICAL AT 2018-05-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209535-002 TRIAMCINOLONE ACETONIDE 0.1% CREAM / TOPICAL AT 2018-05-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209535-003 TRIAMCINOLONE ACETONIDE 0.5% CREAM / TOPICAL AT 2018-05-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209535-001 TRIAMCINOLONE ACETONIDE 0.025% CREAM / TOPICAL AT 2018-05-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209535-002 TRIAMCINOLONE ACETONIDE 0.1% CREAM / TOPICAL AT 2018-05-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209535-003 TRIAMCINOLONE ACETONIDE 0.5% CREAM / TOPICAL AT 2018-05-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209535-001 TRIAMCINOLONE ACETONIDE 0.025% CREAM / TOPICAL AT 2018-05-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209535-002 TRIAMCINOLONE ACETONIDE 0.1% CREAM / TOPICAL AT 2018-05-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209535-003 TRIAMCINOLONE ACETONIDE 0.5% CREAM / TOPICAL AT 2018-05-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209535-001 TRIAMCINOLONE ACETONIDE 0.025% CREAM / TOPICAL AT 2018-05-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209535-002 TRIAMCINOLONE ACETONIDE 0.1% CREAM / TOPICAL AT 2018-05-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209535-003 TRIAMCINOLONE ACETONIDE 0.5% CREAM / TOPICAL AT 2018-05-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209535-001 TRIAMCINOLONE ACETONIDE 0.025% CREAM / TOPICAL AT 2018-05-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A209535-002 TRIAMCINOLONE ACETONIDE 0.1% CREAM / TOPICAL AT 2018-05-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A209535-003 TRIAMCINOLONE ACETONIDE 0.5% CREAM / TOPICAL AT 2018-05-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209535-001 TRIAMCINOLONE ACETONIDE 0.025% CREAM / TOPICAL AT 2018-05-18 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209535-002 TRIAMCINOLONE ACETONIDE 0.1% CREAM / TOPICAL AT 2018-05-18 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209535-003 TRIAMCINOLONE ACETONIDE 0.5% CREAM / TOPICAL AT 2018-05-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209535-001 TRIAMCINOLONE ACETONIDE 0.025% CREAM / TOPICAL AT 2018-05-18 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209535-002 TRIAMCINOLONE ACETONIDE 0.1% CREAM / TOPICAL AT 2018-05-18 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209535-003 TRIAMCINOLONE ACETONIDE 0.5% CREAM / TOPICAL AT 2018-05-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209535-001 TRIAMCINOLONE ACETONIDE 0.025% CREAM / TOPICAL AT 2018-05-18 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209535-002 TRIAMCINOLONE ACETONIDE 0.1% CREAM / TOPICAL AT 2018-05-18 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209535-003 TRIAMCINOLONE ACETONIDE 0.5% CREAM / TOPICAL AT 2018-05-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209535-001 TRIAMCINOLONE ACETONIDE 0.025% CREAM / TOPICAL AT 2018-05-18 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 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 1 · 19 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 36 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 16714-985 Triamcinolone Acetonide Triamcinolone Acetonide NorthStar RxLLC ANDA Current 16714-986 Triamcinolone Acetonide Triamcinolone Acetonide NorthStar RxLLC ANDA Current 16714-987 Triamcinolone Acetonide Triamcinolone Acetonide NorthStar RxLLC ANDA Current 33342-327 Triamcinolone Acetonide Triamcinolone Acetonide Macleods Pharmaceuticals Limited ANDA Current 33342-328 Triamcinolone Acetonide Triamcinolone Acetonide Macleods Pharmaceuticals Limited ANDA Current 33342-329 Triamcinolone Acetonide Triamcinolone Acetonide Macleods Pharmaceuticals Limited ANDA Current 53002-9333 Triamcinolone Acetonide Triamcinolone Acetonide RPK Pharmaceuticals, Inc. ANDA Current 68071-2339 Triamcinolone Acetonide Triamcinolone Acetonide NuCare Pharmaceuticals,Inc. ANDA Current 68071-2339 Triamcinolone Acetonide Triamcinolone Acetonide NuCare Pharmaceuticals,Inc. ANDA Current 68071-2464 Triamcinolone Acetonide Triamcinolone Acetonide NuCare Pharmaceuticals,Inc. ANDA Current 68071-2516 Triamcinolone Acetonide Triamcinolone Acetonide NuCare Pharmaceuticals,Inc. ANDA Current 68071-4945 Triamcinolone Acetonide Triamcinolone Acetonide NuCare Pharmaceuticals,Inc. ANDA Current 68071-5070 Triamcinolone Acetonide Triamcinolone Acetonide NuCare Pharmaceuticals,Inc. ANDA Current 68071-5070 Triamcinolone Acetonide Triamcinolone Acetonide NuCare Pharmaceuticals,Inc. ANDA Current 68788-7501 Triamcinolone Acetonide Triamcinolone Acetonide Preferred Pharmaceuticals, Inc. ANDA Current 68788-7501 Triamcinolone Acetonide Triamcinolone Acetonide Preferred Pharmaceuticals, Inc. ANDA Current 68788-7501 Triamcinolone Acetonide Triamcinolone Acetonide Preferred Pharmaceuticals, Inc. ANDA Current 68788-7501 Triamcinolone Acetonide Triamcinolone Acetonide Preferred Pharmaceuticals, Inc. ANDA Current 68788-7506 Triamcinolone Acetonide Triamcinolone Acetonide Preferred Pharmaceuticals, Inc. ANDA Current 68788-7506 Triamcinolone Acetonide Triamcinolone Acetonide Preferred Pharmaceuticals, Inc. ANDA Current 68788-7506 Triamcinolone Acetonide Triamcinolone Acetonide Preferred Pharmaceuticals, Inc. ANDA Current 68788-7506 Triamcinolone Acetonide Triamcinolone Acetonide Preferred Pharmaceuticals, Inc. ANDA Current 68788-7797 Triamcinolone Acetonide Triamcinolone Acetonide Preferred Pharmaceuticals Inc ANDA Current 68788-7797 Triamcinolone Acetonide Triamcinolone Acetonide Preferred Pharmaceuticals Inc ANDA Current 68788-7797 Triamcinolone Acetonide Triamcinolone Acetonide Preferred Pharmaceuticals Inc ANDA Current 70518-2938 Triamcinolone Acetonide Triamcinolone Acetonide REMEDYREPACK INC. ANDA Current 70518-2938 Triamcinolone Acetonide Triamcinolone Acetonide REMEDYREPACK INC. ANDA Current 70518-2938 Triamcinolone Acetonide Triamcinolone Acetonide REMEDYREPACK INC. ANDA Current 70518-2963 Triamcinolone Acetonide Triamcinolone Acetonide REMEDYREPACK INC. ANDA Current 70518-2963 Triamcinolone Acetonide Triamcinolone Acetonide REMEDYREPACK INC. ANDA Current 70518-2963 Triamcinolone Acetonide Triamcinolone Acetonide REMEDYREPACK INC. ANDA Current 71205-627 Triamcinolone Acetonide Triamcinolone Acetonide Proficient Rx LP ANDA Current 71205-627 Triamcinolone Acetonide Triamcinolone Acetonide Proficient Rx LP ANDA Current 72189-277 TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE Direct_Rx ANDA Current 72189-277 TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE Direct_Rx ANDA Current 76420-203 Triamcinolone Acetonide Triamcinolone Acetonide Asclemed USA, Inc. ANDA Current