Home Applications 217123 Application 217123
Type ANDA
Sponsor AUROBINDO PHARMA LTD Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 DEFLAZACORT DEFLAZACORT TABLET;ORAL 6MG No No 002 DEFLAZACORT DEFLAZACORT TABLET;ORAL 18MG No No 003 DEFLAZACORT DEFLAZACORT TABLET;ORAL 30MG No No 004 DEFLAZACORT DEFLAZACORT TABLET;ORAL 36MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A217123-001 DEFLAZACORT DEFLAZACORT 6MG TABLET / ORAL AB 2024-02-09 A217123-002 DEFLAZACORT DEFLAZACORT 18MG TABLET / ORAL AB 2024-02-09 A217123-003 DEFLAZACORT DEFLAZACORT 30MG TABLET / ORAL AB 2024-02-09 A217123-004 DEFLAZACORT DEFLAZACORT 36MG TABLET / ORAL AB 2024-02-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 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 2 · 64 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 A217123-001 DEFLAZACORT 6MG TABLET / ORAL AB 2024-02-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217123-002 DEFLAZACORT 18MG TABLET / ORAL AB 2024-02-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217123-003 DEFLAZACORT 30MG TABLET / ORAL AB 2024-02-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217123-004 DEFLAZACORT 36MG TABLET / ORAL AB 2024-02-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217123-001 DEFLAZACORT 6MG TABLET / ORAL AB 2024-02-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217123-002 DEFLAZACORT 18MG TABLET / ORAL AB 2024-02-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217123-003 DEFLAZACORT 30MG TABLET / ORAL AB 2024-02-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217123-004 DEFLAZACORT 36MG TABLET / ORAL AB 2024-02-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217123-001 DEFLAZACORT 6MG TABLET / ORAL AB 2024-02-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217123-002 DEFLAZACORT 18MG TABLET / ORAL AB 2024-02-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217123-003 DEFLAZACORT 30MG TABLET / ORAL AB 2024-02-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217123-004 DEFLAZACORT 36MG TABLET / ORAL AB 2024-02-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217123-001 DEFLAZACORT 6MG TABLET / ORAL AB 2024-02-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217123-002 DEFLAZACORT 18MG TABLET / ORAL AB 2024-02-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217123-003 DEFLAZACORT 30MG TABLET / ORAL AB 2024-02-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217123-004 DEFLAZACORT 36MG TABLET / ORAL AB 2024-02-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217123-001 DEFLAZACORT 6MG TABLET / ORAL AB 2024-02-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217123-002 DEFLAZACORT 18MG TABLET / ORAL AB 2024-02-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217123-003 DEFLAZACORT 30MG TABLET / ORAL AB 2024-02-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217123-004 DEFLAZACORT 36MG TABLET / ORAL AB 2024-02-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217123-001 DEFLAZACORT 6MG TABLET / ORAL AB 2024-02-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217123-002 DEFLAZACORT 18MG TABLET / ORAL AB 2024-02-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217123-003 DEFLAZACORT 30MG TABLET / ORAL AB 2024-02-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217123-004 DEFLAZACORT 36MG TABLET / ORAL AB 2024-02-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217123-001 DEFLAZACORT 6MG TABLET / ORAL AB 2024-02-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217123-002 DEFLAZACORT 18MG TABLET / ORAL AB 2024-02-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217123-003 DEFLAZACORT 30MG TABLET / ORAL AB 2024-02-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217123-004 DEFLAZACORT 36MG TABLET / ORAL AB 2024-02-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217123-001 DEFLAZACORT 6MG TABLET / ORAL AB 2024-02-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217123-002 DEFLAZACORT 18MG TABLET / ORAL AB 2024-02-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217123-003 DEFLAZACORT 30MG TABLET / ORAL AB 2024-02-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217123-004 DEFLAZACORT 36MG TABLET / ORAL AB 2024-02-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217123-001 DEFLAZACORT 6MG TABLET / ORAL AB 2024-02-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217123-002 DEFLAZACORT 18MG TABLET / ORAL AB 2024-02-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217123-003 DEFLAZACORT 30MG TABLET / ORAL AB 2024-02-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217123-004 DEFLAZACORT 36MG TABLET / ORAL AB 2024-02-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A217123-001 DEFLAZACORT 6MG TABLET / ORAL AB 2024-02-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A217123-002 DEFLAZACORT 18MG TABLET / ORAL AB 2024-02-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A217123-003 DEFLAZACORT 30MG TABLET / ORAL AB 2024-02-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A217123-004 DEFLAZACORT 36MG TABLET / ORAL AB 2024-02-09 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 64 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 · 1 matching rows.
Documents# Document, Submission type, Date table Document Submission type Date 77744 ORIG 2024-03-07