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 42 .
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 · 126 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 2026-08-18 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…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207651-002 TRIAMCINOLONE ACETONIDE 0.1% CREAM / TOPICAL AT 2017-12-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207651-003 TRIAMCINOLONE ACETONIDE 0.5% CREAM / TOPICAL AT 2017-12-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207651-001 TRIAMCINOLONE ACETONIDE 0.025% CREAM / TOPICAL AT 2017-12-26 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 126 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 · 214 matching rows.
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