Home Applications 208685 Application 208685
Type NDA
Sponsor PTC THERAP Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 EMFLAZA DEFLAZACORT SUSPENSION;ORAL 22.75MG/ML Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N208685-001 EMFLAZA DEFLAZACORT 22.75MG/ML SUSPENSION / ORAL AB RLD, RS 2017-02-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N208685-001 AB
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N208685-001 ODE-252 2026-06-07
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 · 41 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 N208685-001 EMFLAZA 22.75MG/ML SUSPENSION / ORAL AB RLD, RS 2017-02-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208685-001 EMFLAZA 22.75MG/ML SUSPENSION / ORAL AB RLD, RS 2017-02-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208685-001 EMFLAZA 22.75MG/ML SUSPENSION / ORAL AB RLD, RS 2017-02-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208685-001 EMFLAZA 22.75MG/ML SUSPENSION / ORAL AB RLD, RS 2017-02-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208685-001 EMFLAZA 22.75MG/ML SUSPENSION / ORAL AB RLD, RS 2017-02-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208685-001 EMFLAZA 22.75MG/ML SUSPENSION / ORAL AB RLD, RS 2017-02-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208685-001 EMFLAZA 22.75MG/ML SUSPENSION / ORAL AB RLD, RS 2017-02-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208685-001 EMFLAZA 22.75MG/ML SUSPENSION / ORAL AB RLD, RS 2017-02-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208685-001 EMFLAZA 22.75MG/ML SUSPENSION / ORAL AB RLD, RS 2017-02-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N208685-001 EMFLAZA 22.75MG/ML SUSPENSION / ORAL AB RLD, RS 2017-02-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208685-001 EMFLAZA 22.75MG/ML SUSPENSION / ORAL AB RLD, RS 2017-02-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208685-001 EMFLAZA 22.75MG/ML SUSPENSION / ORAL AB RLD, RS 2017-02-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208685-001 EMFLAZA 22.75MG/ML SUSPENSION / ORAL AB RLD, RS 2017-02-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N208685-001 EMFLAZA 22.75MG/ML SUSPENSION / ORAL AB RLD, RS 2017-02-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208685-001 EMFLAZA 22.75MG/ML SUSPENSION / ORAL RLD, RS 2017-02-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N208685-001 EMFLAZA 22.75MG/ML SUSPENSION / ORAL RLD, RS 2017-02-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N208685-001 EMFLAZA 22.75MG/ML SUSPENSION / ORAL RLD, RS 2017-02-09 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N208685-001 EMFLAZA 22.75MG/ML SUSPENSION / ORAL RLD, RS 2017-02-09 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N208685-001 EMFLAZA 22.75MG/ML SUSPENSION / ORAL RLD, RS 2017-02-09 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N208685-001 EMFLAZA 22.75MG/ML SUSPENSION / ORAL RLD, RS 2017-02-09 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N208685-001 EMFLAZA 22.75MG/ML SUSPENSION / ORAL RLD, RS 2017-02-09 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N208685-001 EMFLAZA 22.75MG/ML SUSPENSION / ORAL RLD, RS 2017-02-09 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N208685-001 EMFLAZA 22.75MG/ML SUSPENSION / ORAL RLD, RS 2017-02-09 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N208685-001 EMFLAZA 22.75MG/ML SUSPENSION / ORAL RLD, RS 2017-02-09 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N208685-001 EMFLAZA 22.75MG/ML SUSPENSION / ORAL RLD, RS 2017-02-09 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N208685-001 EMFLAZA 22.75MG/ML SUSPENSION / ORAL RLD, RS 2017-02-09 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N208685-001 EMFLAZA 22.75MG/ML SUSPENSION / ORAL RLD, RS 2017-02-09 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N208685-001 EMFLAZA 22.75MG/ML SUSPENSION / ORAL RLD, RS 2017-02-09 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N208685-001 EMFLAZA 22.75MG/ML SUSPENSION / ORAL RLD, RS 2017-02-09 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N208685-001 EMFLAZA 22.75MG/ML SUSPENSION / ORAL RLD, RS 2017-02-09 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N208685-001 EMFLAZA 22.75MG/ML SUSPENSION / ORAL RLD, RS 2017-02-09 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N208685-001 EMFLAZA 22.75MG/ML SUSPENSION / ORAL RLD, RS 2017-02-09 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N208685-001 EMFLAZA 22.75MG/ML SUSPENSION / ORAL RLD, RS 2017-02-09 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N208685-001 EMFLAZA 22.75MG/ML SUSPENSION / ORAL RLD, RS 2017-02-09 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N208685-001 EMFLAZA 22.75MG/ML SUSPENSION / ORAL RLD, RS 2017-02-09 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N208685-001 EMFLAZA 22.75MG/ML SUSPENSION / ORAL RLD, RS 2017-02-09 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N208685-001 EMFLAZA 22.75MG/ML SUSPENSION / ORAL RLD, RS 2017-02-09 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N208685-001 EMFLAZA 22.75MG/ML SUSPENSION / ORAL RLD, RS 2017-02-09 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N208685-001 EMFLAZA 22.75MG/ML SUSPENSION / ORAL RLD, RS 2017-02-09 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N208685-001 EMFLAZA 22.75MG/ML SUSPENSION / ORAL RLD, RS 2017-02-09 cb3db0bc1861…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# Exclusivity history page 1 of 3 · 92 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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 11 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 42998-505 EMFLAZA deflazacort Marathon Pharmaceuticals, LLC NDA Current 42998-505 EMFLAZA deflazacort Marathon Pharmaceuticals, LLC NDA Current 52856-505 EMFLAZA deflazacort PTC Therapeutics, Inc. NDA Current 52856-505 EMFLAZA deflazacort PTC Therapeutics, Inc. NDA Current 52856-505 EMFLAZA deflazacort PTC Therapeutics, Inc. NDA Current 52856-505 EMFLAZA deflazacort PTC Therapeutics, Inc. NDA Current 52856-505 EMFLAZA deflazacort PTC Therapeutics, Inc. NDA Current 52856-505 EMFLAZA deflazacort PTC Therapeutics, Inc. NDA Current 52856-505 EMFLAZA deflazacort PTC Therapeutics, Inc. NDA Current 52856-505 EMFLAZA deflazacort PTC Therapeutics, Inc. NDA Current 52856-505 EMFLAZA deflazacort PTC Therapeutics, Inc. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 78740 SUPPL 2024-07-02 78664 SUPPL 2024-06-06 70086 SUPPL 2022-02-04 67979 SUPPL 2021-06-30 63951 SUPPL 2020-07-17 63891 SUPPL 2020-07-14 59010 SUPPL 2019-06-11 58989 SUPPL 2019-06-07 47142 ORIG 2017-02-09 47141 ORIG 2017-02-09