Home Applications 011161 Application 011161
Type NDA
Sponsor ASTELLAS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 004 ARISTOCORT TRIAMCINOLONE TABLET;ORAL 2MG No No 007 ARISTOCORT TRIAMCINOLONE TABLET;ORAL 4MG No No 009 ARISTOCORT TRIAMCINOLONE TABLET;ORAL 1MG No No 010 ARISTOCORT TRIAMCINOLONE TABLET;ORAL 16MG No No 011 ARISTOCORT TRIAMCINOLONE TABLET;ORAL 8MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N011161-004 ARISTOCORT TRIAMCINOLONE 2MG TABLET / ORAL Approved before 1982 N011161-007 ARISTOCORT TRIAMCINOLONE 4MG TABLET / ORAL Approved before 1982 N011161-009 ARISTOCORT TRIAMCINOLONE 1MG TABLET / ORAL Approved before 1982 N011161-010 ARISTOCORT TRIAMCINOLONE 16MG TABLET / ORAL Approved before 1982 N011161-011 ARISTOCORT TRIAMCINOLONE 8MG TABLET / ORAL Approved before 1982
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 6 · 205 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 N011161-004 ARISTOCORT 2MG TABLET / ORAL Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N011161-007 ARISTOCORT 4MG TABLET / ORAL Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N011161-009 ARISTOCORT 1MG TABLET / ORAL Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N011161-010 ARISTOCORT 16MG TABLET / ORAL Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N011161-011 ARISTOCORT 8MG TABLET / ORAL Approved before 1982 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N011161-004 ARISTOCORT 2MG TABLET / ORAL Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N011161-007 ARISTOCORT 4MG TABLET / ORAL Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N011161-009 ARISTOCORT 1MG TABLET / ORAL Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N011161-010 ARISTOCORT 16MG TABLET / ORAL Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N011161-011 ARISTOCORT 8MG TABLET / ORAL Approved before 1982 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N011161-004 ARISTOCORT 2MG TABLET / ORAL Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N011161-007 ARISTOCORT 4MG TABLET / ORAL Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N011161-009 ARISTOCORT 1MG TABLET / ORAL Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N011161-010 ARISTOCORT 16MG TABLET / ORAL Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N011161-011 ARISTOCORT 8MG TABLET / ORAL Approved before 1982 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N011161-004 ARISTOCORT 2MG TABLET / ORAL Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N011161-007 ARISTOCORT 4MG TABLET / ORAL Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N011161-009 ARISTOCORT 1MG TABLET / ORAL Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N011161-010 ARISTOCORT 16MG TABLET / ORAL Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N011161-011 ARISTOCORT 8MG TABLET / ORAL Approved before 1982 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N011161-004 ARISTOCORT 2MG TABLET / ORAL Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N011161-007 ARISTOCORT 4MG TABLET / ORAL Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N011161-009 ARISTOCORT 1MG TABLET / ORAL Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N011161-010 ARISTOCORT 16MG TABLET / ORAL Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N011161-011 ARISTOCORT 8MG TABLET / ORAL Approved before 1982 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N011161-004 ARISTOCORT 2MG TABLET / ORAL Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N011161-007 ARISTOCORT 4MG TABLET / ORAL Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N011161-009 ARISTOCORT 1MG TABLET / ORAL Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N011161-010 ARISTOCORT 16MG TABLET / ORAL Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N011161-011 ARISTOCORT 8MG TABLET / ORAL Approved before 1982 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N011161-004 ARISTOCORT 2MG TABLET / ORAL Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N011161-007 ARISTOCORT 4MG TABLET / ORAL Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N011161-009 ARISTOCORT 1MG TABLET / ORAL Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N011161-010 ARISTOCORT 16MG TABLET / ORAL Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N011161-011 ARISTOCORT 8MG TABLET / ORAL Approved before 1982 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N011161-004 ARISTOCORT 2MG TABLET / ORAL Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N011161-007 ARISTOCORT 4MG TABLET / ORAL Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N011161-009 ARISTOCORT 1MG TABLET / ORAL Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N011161-010 ARISTOCORT 16MG TABLET / ORAL Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N011161-011 ARISTOCORT 8MG TABLET / ORAL Approved before 1982 5bbf6a4d5a75…