Home Applications 207223 Application 207223
Type NDA
Sponsor BIOCODEX SA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 DIACOMIT STIRIPENTOL FOR SUSPENSION;ORAL 250MG/PACKET Yes No 002 DIACOMIT STIRIPENTOL FOR SUSPENSION;ORAL 500MG/PACKET Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N207223-001 DIACOMIT STIRIPENTOL 250MG/PACKET FOR SUSPENSION / ORAL RLD 2018-08-20 N207223-002 DIACOMIT STIRIPENTOL 500MG/PACKET FOR SUSPENSION / ORAL RLD, RS 2018-08-20
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N207223-001 ODE-403 2029-07-14 N207223-002 ODE-403 2029-07-14
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 3 · 82 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 N207223-001 DIACOMIT 250MG/PACKET FOR SUSPENSION / ORAL RLD 2018-08-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207223-002 DIACOMIT 500MG/PACKET FOR SUSPENSION / ORAL RLD, RS 2018-08-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207223-001 DIACOMIT 250MG/PACKET FOR SUSPENSION / ORAL RLD 2018-08-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207223-002 DIACOMIT 500MG/PACKET FOR SUSPENSION / ORAL RLD, RS 2018-08-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N207223-001 DIACOMIT 250MG/PACKET FOR SUSPENSION / ORAL RLD 2018-08-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207223-002 DIACOMIT 500MG/PACKET FOR SUSPENSION / ORAL RLD, RS 2018-08-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207223-001 DIACOMIT 250MG/PACKET FOR SUSPENSION / ORAL RLD 2018-08-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207223-002 DIACOMIT 500MG/PACKET FOR SUSPENSION / ORAL RLD, RS 2018-08-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207223-001 DIACOMIT 250MG/PACKET FOR SUSPENSION / ORAL RLD 2018-08-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207223-002 DIACOMIT 500MG/PACKET FOR SUSPENSION / ORAL RLD, RS 2018-08-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207223-001 DIACOMIT 250MG/PACKET FOR SUSPENSION / ORAL RLD 2018-08-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207223-002 DIACOMIT 500MG/PACKET FOR SUSPENSION / ORAL RLD, RS 2018-08-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207223-001 DIACOMIT 250MG/PACKET FOR SUSPENSION / ORAL RLD 2018-08-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207223-002 DIACOMIT 500MG/PACKET FOR SUSPENSION / ORAL RLD, RS 2018-08-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N207223-001 DIACOMIT 250MG/PACKET FOR SUSPENSION / ORAL RLD 2018-08-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N207223-002 DIACOMIT 500MG/PACKET FOR SUSPENSION / ORAL RLD, RS 2018-08-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N207223-001 DIACOMIT 250MG/PACKET FOR SUSPENSION / ORAL RLD 2018-08-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N207223-002 DIACOMIT 500MG/PACKET FOR SUSPENSION / ORAL RLD, RS 2018-08-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N207223-001 DIACOMIT 250MG/PACKET FOR SUSPENSION / ORAL RLD 2018-08-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N207223-002 DIACOMIT 500MG/PACKET FOR SUSPENSION / ORAL RLD, RS 2018-08-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N207223-001 DIACOMIT 250MG/PACKET FOR SUSPENSION / ORAL RLD 2018-08-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N207223-002 DIACOMIT 500MG/PACKET FOR SUSPENSION / ORAL RLD, RS 2018-08-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N207223-001 DIACOMIT 250MG/PACKET FOR SUSPENSION / ORAL RLD 2018-08-20 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N207223-002 DIACOMIT 500MG/PACKET FOR SUSPENSION / ORAL RLD, RS 2018-08-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N207223-001 DIACOMIT 250MG/PACKET FOR SUSPENSION / ORAL RLD 2018-08-20 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N207223-002 DIACOMIT 500MG/PACKET FOR SUSPENSION / ORAL RLD, RS 2018-08-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N207223-001 DIACOMIT 250MG/PACKET FOR SUSPENSION / ORAL RLD 2018-08-20 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N207223-002 DIACOMIT 500MG/PACKET FOR SUSPENSION / ORAL RLD, RS 2018-08-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N207223-001 DIACOMIT 250MG/PACKET FOR SUSPENSION / ORAL RLD 2018-08-20 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N207223-002 DIACOMIT 500MG/PACKET FOR SUSPENSION / ORAL RLD, RS 2018-08-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N207223-001 DIACOMIT 250MG/PACKET FOR SUSPENSION / ORAL RLD 2018-08-20 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N207223-002 DIACOMIT 500MG/PACKET FOR SUSPENSION / ORAL RLD, RS 2018-08-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N207223-001 DIACOMIT 250MG/PACKET FOR SUSPENSION / ORAL RLD 2018-08-20 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N207223-002 DIACOMIT 500MG/PACKET FOR SUSPENSION / ORAL RLD, RS 2018-08-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N207223-001 DIACOMIT 250MG/PACKET FOR SUSPENSION / ORAL RLD 2018-08-20 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N207223-002 DIACOMIT 500MG/PACKET FOR SUSPENSION / ORAL RLD, RS 2018-08-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N207223-001 DIACOMIT 250MG/PACKET FOR SUSPENSION / ORAL RLD 2018-08-20 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N207223-002 DIACOMIT 500MG/PACKET FOR SUSPENSION / ORAL RLD, RS 2018-08-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N207223-001 DIACOMIT 250MG/PACKET FOR SUSPENSION / ORAL RLD 2018-08-20 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N207223-002 DIACOMIT 500MG/PACKET FOR SUSPENSION / ORAL RLD, RS 2018-08-20 782e0a99824c…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 6 · 216 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 · 8 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 68418-7941 Diacomit stiripentol BIOCODEX, INC. NDA Current 68418-7941 Diacomit stiripentol BIOCODEX, INC. NDA Current 68418-7941 Diacomit stiripentol BIOCODEX INC. NDA Current 68418-7941 Diacomit stiripentol BIOCODEX, INC. NDA Current 68418-7942 Diacomit stiripentol BIOCODEX, INC. NDA Current 68418-7942 Diacomit stiripentol BIOCODEX, INC. NDA Current 68418-7942 Diacomit stiripentol BIOCODEX INC. NDA Current 68418-7942 Diacomit stiripentol BIOCODEX, INC. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 85709 SUPPL 2026-04-17 85710 SUPPL 2026-04-16 85699 SUPPL 2026-04-16 71564 SUPPL 2022-07-15 71550 SUPPL 2022-07-14 71549 SUPPL 2022-07-14 55462 ORIG 2018-09-12 55328 ORIG 2018-08-27 55253 ORIG 2018-08-21 55252 ORIG 2018-08-21