Home Applications 208684 Application 208684
Type NDA
Sponsor PTC THERAP Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 EMFLAZA DEFLAZACORT TABLET;ORAL 6MG Yes No 002 EMFLAZA DEFLAZACORT TABLET;ORAL 18MG Yes No 003 EMFLAZA DEFLAZACORT TABLET;ORAL 30MG Yes No 004 EMFLAZA DEFLAZACORT TABLET;ORAL 36MG Yes Yes
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 N208684-001 EMFLAZA DEFLAZACORT 6MG TABLET / ORAL AB RLD 2017-02-09 N208684-002 EMFLAZA DEFLAZACORT 18MG TABLET / ORAL AB RLD 2017-02-09 N208684-003 EMFLAZA DEFLAZACORT 30MG TABLET / ORAL AB RLD 2017-02-09 N208684-004 EMFLAZA DEFLAZACORT 36MG TABLET / ORAL AB RLD, RS 2017-02-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
Orange Book exclusivity# Current exclusivity 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 5 · 164 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 N208684-001 EMFLAZA 6MG TABLET / ORAL AB RLD 2017-02-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208684-002 EMFLAZA 18MG TABLET / ORAL AB RLD 2017-02-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208684-003 EMFLAZA 30MG TABLET / ORAL AB RLD 2017-02-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208684-004 EMFLAZA 36MG TABLET / ORAL AB RLD, RS 2017-02-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208684-001 EMFLAZA 6MG TABLET / ORAL AB RLD 2017-02-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208684-002 EMFLAZA 18MG TABLET / ORAL AB RLD 2017-02-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208684-003 EMFLAZA 30MG TABLET / ORAL AB RLD 2017-02-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208684-004 EMFLAZA 36MG TABLET / ORAL AB RLD, RS 2017-02-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208684-001 EMFLAZA 6MG TABLET / ORAL AB RLD 2017-02-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208684-002 EMFLAZA 18MG TABLET / ORAL AB RLD 2017-02-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208684-003 EMFLAZA 30MG TABLET / ORAL AB RLD 2017-02-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208684-004 EMFLAZA 36MG TABLET / ORAL AB RLD, RS 2017-02-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208684-001 EMFLAZA 6MG TABLET / ORAL AB RLD 2017-02-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208684-002 EMFLAZA 18MG TABLET / ORAL AB RLD 2017-02-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208684-003 EMFLAZA 30MG TABLET / ORAL AB RLD 2017-02-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208684-004 EMFLAZA 36MG TABLET / ORAL AB RLD, RS 2017-02-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208684-001 EMFLAZA 6MG TABLET / ORAL AB RLD 2017-02-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208684-002 EMFLAZA 18MG TABLET / ORAL AB RLD 2017-02-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208684-003 EMFLAZA 30MG TABLET / ORAL AB RLD 2017-02-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208684-004 EMFLAZA 36MG TABLET / ORAL AB RLD, RS 2017-02-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208684-001 EMFLAZA 6MG TABLET / ORAL AB RLD 2017-02-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208684-002 EMFLAZA 18MG TABLET / ORAL AB RLD 2017-02-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208684-003 EMFLAZA 30MG TABLET / ORAL AB RLD 2017-02-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208684-004 EMFLAZA 36MG TABLET / ORAL AB RLD, RS 2017-02-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208684-001 EMFLAZA 6MG TABLET / ORAL AB RLD 2017-02-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208684-002 EMFLAZA 18MG TABLET / ORAL AB RLD 2017-02-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208684-003 EMFLAZA 30MG TABLET / ORAL AB RLD 2017-02-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208684-004 EMFLAZA 36MG TABLET / ORAL AB RLD, RS 2017-02-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208684-001 EMFLAZA 6MG TABLET / ORAL AB RLD 2017-02-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208684-002 EMFLAZA 18MG TABLET / ORAL AB RLD 2017-02-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208684-003 EMFLAZA 30MG TABLET / ORAL AB RLD 2017-02-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208684-004 EMFLAZA 36MG TABLET / ORAL AB RLD, RS 2017-02-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208684-001 EMFLAZA 6MG TABLET / ORAL AB RLD 2017-02-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208684-002 EMFLAZA 18MG TABLET / ORAL AB RLD 2017-02-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208684-003 EMFLAZA 30MG TABLET / ORAL AB RLD 2017-02-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208684-004 EMFLAZA 36MG TABLET / ORAL AB RLD, RS 2017-02-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N208684-001 EMFLAZA 6MG TABLET / ORAL AB RLD 2017-02-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N208684-002 EMFLAZA 18MG TABLET / ORAL AB RLD 2017-02-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N208684-003 EMFLAZA 30MG TABLET / ORAL AB RLD 2017-02-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N208684-004 EMFLAZA 36MG TABLET / ORAL AB RLD, RS 2017-02-09 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 64 observed states.
Observed Orange Book exclusivity history# Exclusivity history page 1 of 10 · 368 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2026-02-19 14:30 UTC 2026-02 N208684-001 ODE-252 2026-06-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208684-002 ODE-252 2026-06-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208684-003 ODE-252 2026-06-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208684-004 ODE-252 2026-06-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208684-001 ODE-252 2026-06-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208684-002 ODE-252 2026-06-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208684-003 ODE-252 2026-06-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208684-004 ODE-252 2026-06-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208684-001 ODE-252 2026-06-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208684-002 ODE-252 2026-06-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208684-003 ODE-252 2026-06-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208684-004 ODE-252 2026-06-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208684-001 ODE-252 2026-06-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208684-002 ODE-252 2026-06-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208684-003 ODE-252 2026-06-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208684-004 ODE-252 2026-06-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208684-001 ODE-252 2026-06-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208684-002 ODE-252 2026-06-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208684-003 ODE-252 2026-06-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208684-004 ODE-252 2026-06-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208684-001 ODE-130 2024-02-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208684-001 ODE-252 2026-06-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208684-002 ODE-130 2024-02-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208684-002 ODE-252 2026-06-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208684-003 ODE-130 2024-02-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208684-003 ODE-252 2026-06-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208684-004 ODE-130 2024-02-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208684-004 ODE-252 2026-06-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208684-001 ODE-130 2024-02-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208684-001 ODE-252 2026-06-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208684-002 ODE-130 2024-02-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208684-002 ODE-252 2026-06-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208684-003 ODE-130 2024-02-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208684-003 ODE-252 2026-06-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208684-004 ODE-130 2024-02-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208684-004 ODE-252 2026-06-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208684-001 ODE-130 2024-02-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208684-001 ODE-252 2026-06-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208684-002 ODE-130 2024-02-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208684-002 ODE-252 2026-06-07 5bbf6a4d5a75…
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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 44 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 42998-501 EMFLAZA deflazacort Marathon Pharmaceuticals, LLC NDA Current 42998-501 EMFLAZA deflazacort Marathon Pharmaceuticals, LLC NDA Current 42998-502 EMFLAZA deflazacort Marathon Pharmaceuticals, LLC NDA Current 42998-502 EMFLAZA deflazacort Marathon Pharmaceuticals, LLC NDA Current 42998-503 EMFLAZA deflazacort Marathon Pharmaceuticals, LLC NDA Current 42998-503 EMFLAZA deflazacort Marathon Pharmaceuticals, LLC NDA Current 42998-504 EMFLAZA deflazacort Marathon Pharmaceuticals, LLC NDA Current 42998-504 EMFLAZA deflazacort Marathon Pharmaceuticals, LLC NDA Current 52856-501 EMFLAZA deflazacort PTC Therapeutics, Inc. NDA Current 52856-501 EMFLAZA deflazacort PTC Therapeutics, Inc. NDA Current 52856-501 EMFLAZA deflazacort PTC Therapeutics, Inc. NDA Current 52856-501 EMFLAZA deflazacort PTC Therapeutics, Inc. NDA Current 52856-501 EMFLAZA deflazacort PTC Therapeutics, Inc. NDA Current 52856-501 EMFLAZA deflazacort PTC Therapeutics, Inc. NDA Current 52856-501 EMFLAZA deflazacort PTC Therapeutics, Inc. NDA Current 52856-501 EMFLAZA deflazacort PTC Therapeutics, Inc. NDA Current 52856-501 EMFLAZA deflazacort PTC Therapeutics, Inc. NDA Current 52856-502 EMFLAZA deflazacort PTC Therapeutics, Inc. NDA Current 52856-502 EMFLAZA deflazacort PTC Therapeutics, Inc. NDA Current 52856-502 EMFLAZA deflazacort PTC Therapeutics, Inc. NDA Current 52856-502 EMFLAZA deflazacort PTC Therapeutics, Inc. NDA Current 52856-502 EMFLAZA deflazacort PTC Therapeutics, Inc. NDA Current 52856-502 EMFLAZA deflazacort PTC Therapeutics, Inc. NDA Current 52856-502 EMFLAZA deflazacort PTC Therapeutics, Inc. NDA Current 52856-502 EMFLAZA deflazacort PTC Therapeutics, Inc. NDA Current 52856-502 EMFLAZA deflazacort PTC Therapeutics, Inc. NDA Current 52856-503 EMFLAZA deflazacort PTC Therapeutics, Inc. NDA Current 52856-503 EMFLAZA deflazacort PTC Therapeutics, Inc. NDA Current 52856-503 EMFLAZA deflazacort PTC Therapeutics, Inc. NDA Current 52856-503 EMFLAZA deflazacort PTC Therapeutics, Inc. NDA Current 52856-503 EMFLAZA deflazacort PTC Therapeutics, Inc. NDA Current 52856-503 EMFLAZA deflazacort PTC Therapeutics, Inc. NDA Current 52856-503 EMFLAZA deflazacort PTC Therapeutics, Inc. NDA Current 52856-503 EMFLAZA deflazacort PTC Therapeutics, Inc. NDA Current 52856-503 EMFLAZA deflazacort PTC Therapeutics, Inc. NDA Current 52856-504 EMFLAZA deflazacort PTC Therapeutics, Inc. NDA Current 52856-504 EMFLAZA deflazacort PTC Therapeutics, Inc. NDA Current 52856-504 EMFLAZA deflazacort PTC Therapeutics, Inc. NDA Current 52856-504 EMFLAZA deflazacort PTC Therapeutics, Inc. NDA Current 52856-504 EMFLAZA deflazacort PTC Therapeutics, Inc. NDA Current 52856-504 EMFLAZA deflazacort PTC Therapeutics, Inc. NDA Current 52856-504 EMFLAZA deflazacort PTC Therapeutics, Inc. NDA Current 52856-504 EMFLAZA deflazacort PTC Therapeutics, Inc. NDA Current 52856-504 EMFLAZA deflazacort PTC Therapeutics, Inc. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 78739 SUPPL 2024-07-02 78663 SUPPL 2024-06-06 70085 SUPPL 2022-02-04 67978 SUPPL 2021-06-30 63950 SUPPL 2020-07-17 63890 SUPPL 2020-07-14 59009 SUPPL 2019-06-11 58996 SUPPL 2019-06-07 47511 ORIG 2017-03-09 47143 ORIG 2017-02-09 47140 ORIG 2017-02-09