Application 206709

Type: NDA
Sponsor: BIOCODEX SA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DIACOMIT	STIRIPENTOL	CAPSULE;ORAL	250MG	Yes	No
002	DIACOMIT	STIRIPENTOL	CAPSULE;ORAL	500MG	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
N206709-001	DIACOMIT	STIRIPENTOL	250MG	CAPSULE / ORAL		RLD	2018-08-20
N206709-002	DIACOMIT	STIRIPENTOL	500MG	CAPSULE / 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
N206709-001	ODE-403	2029-07-14
N206709-002	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N206709-001	DIACOMIT	250MG	CAPSULE / ORAL	RLD	2018-08-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206709-002	DIACOMIT	500MG	CAPSULE / ORAL	RLD, RS	2018-08-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206709-001	DIACOMIT	250MG	CAPSULE / ORAL	RLD	2018-08-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206709-002	DIACOMIT	500MG	CAPSULE / ORAL	RLD, RS	2018-08-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N206709-001	DIACOMIT	250MG	CAPSULE / ORAL	RLD	2018-08-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206709-002	DIACOMIT	500MG	CAPSULE / ORAL	RLD, RS	2018-08-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206709-001	DIACOMIT	250MG	CAPSULE / ORAL	RLD	2018-08-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206709-002	DIACOMIT	500MG	CAPSULE / ORAL	RLD, RS	2018-08-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206709-001	DIACOMIT	250MG	CAPSULE / ORAL	RLD	2018-08-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206709-002	DIACOMIT	500MG	CAPSULE / ORAL	RLD, RS	2018-08-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206709-001	DIACOMIT	250MG	CAPSULE / ORAL	RLD	2018-08-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206709-002	DIACOMIT	500MG	CAPSULE / ORAL	RLD, RS	2018-08-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206709-001	DIACOMIT	250MG	CAPSULE / ORAL	RLD	2018-08-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206709-002	DIACOMIT	500MG	CAPSULE / ORAL	RLD, RS	2018-08-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206709-001	DIACOMIT	250MG	CAPSULE / ORAL	RLD	2018-08-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206709-002	DIACOMIT	500MG	CAPSULE / ORAL	RLD, RS	2018-08-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206709-001	DIACOMIT	250MG	CAPSULE / ORAL	RLD	2018-08-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206709-002	DIACOMIT	500MG	CAPSULE / ORAL	RLD, RS	2018-08-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N206709-001	DIACOMIT	250MG	CAPSULE / ORAL	RLD	2018-08-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N206709-002	DIACOMIT	500MG	CAPSULE / ORAL	RLD, RS	2018-08-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206709-001	DIACOMIT	250MG	CAPSULE / ORAL	RLD	2018-08-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206709-002	DIACOMIT	500MG	CAPSULE / ORAL	RLD, RS	2018-08-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206709-001	DIACOMIT	250MG	CAPSULE / ORAL	RLD	2018-08-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206709-002	DIACOMIT	500MG	CAPSULE / ORAL	RLD, RS	2018-08-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N206709-001	DIACOMIT	250MG	CAPSULE / ORAL	RLD	2018-08-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N206709-002	DIACOMIT	500MG	CAPSULE / ORAL	RLD, RS	2018-08-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N206709-001	DIACOMIT	250MG	CAPSULE / ORAL	RLD	2018-08-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N206709-002	DIACOMIT	500MG	CAPSULE / ORAL	RLD, RS	2018-08-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N206709-001	DIACOMIT	250MG	CAPSULE / ORAL	RLD	2018-08-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N206709-002	DIACOMIT	500MG	CAPSULE / ORAL	RLD, RS	2018-08-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N206709-001	DIACOMIT	250MG	CAPSULE / ORAL	RLD	2018-08-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N206709-002	DIACOMIT	500MG	CAPSULE / ORAL	RLD, RS	2018-08-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N206709-001	DIACOMIT	250MG	CAPSULE / ORAL	RLD	2018-08-20	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N206709-002	DIACOMIT	500MG	CAPSULE / ORAL	RLD, RS	2018-08-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N206709-001	DIACOMIT	250MG	CAPSULE / ORAL	RLD	2018-08-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N206709-002	DIACOMIT	500MG	CAPSULE / ORAL	RLD, RS	2018-08-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N206709-001	DIACOMIT	250MG	CAPSULE / ORAL	RLD	2018-08-20	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N206709-002	DIACOMIT	500MG	CAPSULE / ORAL	RLD, RS	2018-08-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N206709-001	DIACOMIT	250MG	CAPSULE / ORAL	RLD	2018-08-20	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N206709-002	DIACOMIT	500MG	CAPSULE / ORAL	RLD, RS	2018-08-20	`782e0a99824c…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 6 · 216 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	N206709-001	ODE-403	2029-07-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206709-002	ODE-403	2029-07-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206709-001	M-281	2025-07-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206709-001	ODE-198	2025-08-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206709-001	ODE-403	2029-07-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206709-002	M-281	2025-07-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206709-002	ODE-198	2025-08-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206709-002	ODE-403	2029-07-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N206709-001	M-281	2025-07-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206709-001	ODE-198	2025-08-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206709-001	ODE-403	2029-07-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206709-002	M-281	2025-07-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206709-002	ODE-198	2025-08-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206709-002	ODE-403	2029-07-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206709-001	M-281	2025-07-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206709-001	ODE-198	2025-08-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206709-001	ODE-403	2029-07-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206709-002	M-281	2025-07-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206709-002	ODE-198	2025-08-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206709-002	ODE-403	2029-07-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206709-001	M-281	2025-07-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206709-001	ODE-198	2025-08-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206709-001	ODE-403	2029-07-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206709-002	M-281	2025-07-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206709-002	ODE-198	2025-08-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206709-002	ODE-403	2029-07-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206709-001	M-281	2025-07-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206709-001	ODE-198	2025-08-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206709-001	ODE-403	2029-07-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206709-002	M-281	2025-07-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206709-002	ODE-198	2025-08-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206709-002	ODE-403	2029-07-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206709-001	M-281	2025-07-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206709-001	ODE-198	2025-08-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206709-001	ODE-403	2029-07-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206709-002	M-281	2025-07-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206709-002	ODE-198	2025-08-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206709-002	ODE-403	2029-07-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206709-001	M-281	2025-07-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206709-001	ODE-198	2025-08-20	`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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diacomit	STIRIPENTOL	BIOCODEX, INC.	58304ba8-9779-4658-811e-94ffe08c3f16	2026-04-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 206709 application number: NDA206709 ndc (product): 68418-7939 ndc (product): 68418-7940

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
68418-7939	Diacomit	stiripentol	BIOCODEX, INC.	NDA	Current
68418-7939	Diacomit	stiripentol	BIOCODEX, INC.	NDA	Current
68418-7939	Diacomit	stiripentol	BIOCODEX INC.	NDA	Current
68418-7939	Diacomit	stiripentol	BIOCODEX, INC.	NDA	Current
68418-7940	Diacomit	stiripentol	BIOCODEX, INC.	NDA	Current
68418-7940	Diacomit	stiripentol	BIOCODEX, INC.	NDA	Current
68418-7940	Diacomit	stiripentol	BIOCODEX INC.	NDA	Current
68418-7940	Diacomit	stiripentol	BIOCODEX, INC.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85707	SUPPL	2026-04-17
85708	SUPPL	2026-04-16
85698	SUPPL	2026-04-16
71563	SUPPL	2022-07-15
71548	SUPPL	2022-07-14
71547	SUPPL	2022-07-14
55461	ORIG	2018-09-12
55327	ORIG	2018-08-27
55251	ORIG	2018-08-21
55250	ORIG	2018-08-21