Application 210365

Type: NDA
Sponsor: GW RES LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	EPIDIOLEX	CANNABIDIOL	SOLUTION;ORAL	100MG/ML	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N210365-001	EPIDIOLEX	CANNABIDIOL	100MG/ML	SOLUTION / ORAL		RLD, RS	2018-09-28

Orange Book patents#

Current patent rows page 1 of 1 · 60 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N210365-001	10092525	2035-06-17	U-2427		2018-10-25
N210365-001	10111840	2035-06-17	U-2442		2018-11-27
N210365-001	10111840	2035-06-17	U-2443		2018-11-27
N210365-001	10137095	2035-06-17	U-2454		2018-12-17
N210365-001	10137095	2035-06-17	U-2455		2018-12-17
N210365-001	10603288	2035-06-17	U-2780		2020-04-27
N210365-001	10603288	2035-06-17	U-2781		2020-04-27
N210365-001	10603288	2035-06-17	U-2782		2020-04-27
N210365-001	10603288	2035-06-17	U-2783		2020-04-27
N210365-001	10709671	2035-06-17	U-2862		2020-07-30
N210365-001	10709673	2035-06-17		Drug product	2020-07-30
N210365-001	10709674	2035-06-17	U-2780		2020-07-30
N210365-001	10709674	2035-06-17	U-2781		2020-07-30
N210365-001	10849860	2035-06-17	U-2427		2020-11-18
N210365-001	10849860	2035-06-17	U-2454		2020-11-18
N210365-001	10966939	2035-06-17	U-2780	Drug product	2021-04-30
N210365-001	10966939	2035-06-17	U-2781	Drug product	2021-04-30
N210365-001	11154516	2035-06-17	U-3235		2021-11-04
N210365-001	11154516	2035-06-17	U-3236		2021-11-04
N210365-001	11311498	2035-06-17	U-3375		2022-05-20
N210365-001	11311498	2035-06-17	U-3376		2022-05-20
N210365-001	11357741	2035-06-17	U-2862		2022-07-13
N210365-001	11446258	2035-06-17	U-2780		2022-10-12
N210365-001	11446258	2035-06-17	U-2781		2022-10-12
N210365-001	11446258	2035-06-17	U-3071		2022-10-12
N210365-001	11633369	2035-06-17	U-2780	Drug product	2023-05-24
N210365-001	11633369	2035-06-17	U-2781	Drug product	2023-05-24
N210365-001	11633369	2035-06-17	U-3071	Drug product	2023-05-24
N210365-001	11701330	2035-06-17	U-2780		2023-08-15
N210365-001	11701330	2035-06-17	U-2781		2023-08-15
N210365-001	11766411	2035-06-17	U-2781		2023-10-19
N210365-001	11963937	2035-06-17	U-2780		2024-05-21
N210365-001	11963937	2035-06-17	U-2781		2024-05-21
N210365-001	12064399	2035-06-17	U-3988		2024-09-19
N210365-001	12064399	2035-06-17	U-3989		2024-09-19
N210365-001	9949937	2035-06-17	U-2421		2018-10-25
N210365-001	9956183	2035-06-17	U-2422		2018-10-25
N210365-001	9956183	2035-06-17	U-2423		2018-10-25
N210365-001	9956184	2035-06-17	U-2424		2018-10-25
N210365-001	9956185	2035-06-17	U-2425		2018-10-25
N210365-001	9956186	2035-06-17	U-2426		2018-10-25
N210365-001	10918608	2035-10-13	U-3071		2021-02-26
N210365-001	10918608	2035-10-13	U-3072		2021-02-26
N210365-001	10918608	2035-10-13	U-3073		2021-02-26
N210365-001	11065209	2035-10-13	U-3071		2021-08-17
N210365-001	11096905	2035-10-13	U-2780	Drug substance, Drug product	2021-09-16
N210365-001	11096905	2035-10-13	U-2781	Drug substance, Drug product	2021-09-16
N210365-001	11400055	2035-10-13	U-3071		2022-08-31
N210365-001	11207292	2039-04-26	U-3235	Drug substance	2022-01-19
N210365-001	11207292	2039-04-26	U-3236	Drug substance	2022-01-19
N210365-001	11207292	2039-04-26	U-3277	Drug substance	2022-01-19
N210365-001	11865102	2039-04-26	U-2781	Drug substance, Drug product	2024-01-30
N210365-001	11865102	2039-04-26	U-3236	Drug substance, Drug product	2024-01-30
N210365-001	11865102	2039-04-26	U-3277	Drug substance, Drug product	2024-01-30
N210365-001	11160795	2041-03-01	U-3233		2021-11-04
N210365-001	11406623	2041-03-01	U-3233		2022-08-31
N210365-001	12102619	2041-03-01	U-3233		2024-10-31
N210365-001	12661365	2042-09-24	U-4573		2026-07-16
N210365-001	12661365	2042-09-24	U-4574		2026-07-16
N210365-001	12661365	2042-09-24	U-4575		2026-07-16

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 3 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N210365-001	M-270	2026-10-20
N210365-001	ODE-326	2027-07-31
N210365-001	ODE-332	2027-07-31

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N210365-001	EPIDIOLEX	100MG/ML	SOLUTION / ORAL	RLD, RS	2018-09-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N210365-001	EPIDIOLEX	100MG/ML	SOLUTION / ORAL	RLD, RS	2018-09-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N210365-001	EPIDIOLEX	100MG/ML	SOLUTION / ORAL	RLD, RS	2018-09-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210365-001	EPIDIOLEX	100MG/ML	SOLUTION / ORAL	RLD, RS	2018-09-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N210365-001	EPIDIOLEX	100MG/ML	SOLUTION / ORAL	RLD, RS	2018-09-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210365-001	EPIDIOLEX	100MG/ML	SOLUTION / ORAL	RLD, RS	2018-09-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210365-001	EPIDIOLEX	100MG/ML	SOLUTION / ORAL	RLD, RS	2018-09-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210365-001	EPIDIOLEX	100MG/ML	SOLUTION / ORAL	RLD, RS	2018-09-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210365-001	EPIDIOLEX	100MG/ML	SOLUTION / ORAL	RLD, RS	2018-09-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210365-001	EPIDIOLEX	100MG/ML	SOLUTION / ORAL	RLD, RS	2018-09-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210365-001	EPIDIOLEX	100MG/ML	SOLUTION / ORAL	RLD, RS	2018-09-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N210365-001	EPIDIOLEX	100MG/ML	SOLUTION / ORAL	RLD, RS	2018-09-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210365-001	EPIDIOLEX	100MG/ML	SOLUTION / ORAL	RLD, RS	2018-09-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210365-001	EPIDIOLEX	100MG/ML	SOLUTION / ORAL	RLD, RS	2018-09-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N210365-001	EPIDIOLEX	100MG/ML	SOLUTION / ORAL	RLD, RS	2018-09-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N210365-001	EPIDIOLEX	100MG/ML	SOLUTION / ORAL	RLD, RS	2018-09-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210365-001	EPIDIOLEX	100MG/ML	SOLUTION / ORAL	RLD, RS	2018-09-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N210365-001	EPIDIOLEX	100MG/ML	SOLUTION / ORAL	RLD, RS	2018-09-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N210365-001	EPIDIOLEX	100MG/ML	SOLUTION / ORAL	RLD, RS	2018-09-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N210365-001	EPIDIOLEX	100MG/ML	SOLUTION / ORAL	RLD, RS	2018-09-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N210365-001	EPIDIOLEX	100MG/ML	SOLUTION / ORAL	RLD, RS	2018-09-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N210365-001	EPIDIOLEX	100MG/ML	SOLUTION / ORAL	RLD, RS	2018-09-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N210365-001	EPIDIOLEX	100MG/ML	SOLUTION / ORAL	RLD, RS	2018-09-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N210365-001	EPIDIOLEX	100MG/ML	SOLUTION / ORAL	RLD, RS	2018-09-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N210365-001	EPIDIOLEX	100MG/ML	SOLUTION / ORAL	RLD, RS	2018-09-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N210365-001	EPIDIOLEX	100MG/ML	SOLUTION / ORAL	RLD, RS	2018-09-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N210365-001	EPIDIOLEX	100MG/ML	SOLUTION / ORAL	RLD, RS	2018-09-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N210365-001	EPIDIOLEX	100MG/ML	SOLUTION / ORAL	RLD, RS	2018-09-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N210365-001	EPIDIOLEX	100MG/ML	SOLUTION / ORAL	RLD, RS	2018-09-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N210365-001	EPIDIOLEX	100MG/ML	SOLUTION / ORAL	RLD, RS	2018-09-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N210365-001	EPIDIOLEX	100MG/ML	SOLUTION / ORAL	RLD, RS	2018-09-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N210365-001	EPIDIOLEX	100MG/ML	SOLUTION / ORAL	RLD, RS	2018-09-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N210365-001	EPIDIOLEX	100MG/ML	SOLUTION / ORAL	RLD, RS	2018-09-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N210365-001	EPIDIOLEX	100MG/ML	SOLUTION / ORAL	RLD, RS	2018-09-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N210365-001	EPIDIOLEX	100MG/ML	SOLUTION / ORAL	RLD, RS	2018-09-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N210365-001	EPIDIOLEX	100MG/ML	SOLUTION / ORAL	RLD, RS	2018-09-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N210365-001	EPIDIOLEX	100MG/ML	SOLUTION / ORAL	RLD, RS	2018-09-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N210365-001	EPIDIOLEX	100MG/ML	SOLUTION / ORAL	RLD, RS	2018-09-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N210365-001	EPIDIOLEX	100MG/ML	SOLUTION / ORAL	RLD, RS	2018-09-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N210365-001	EPIDIOLEX	100MG/ML	SOLUTION / ORAL	RLD, RS	2018-09-28	`f41ea6bd6efb…`

Observed Orange Book patent history#

Patent history page 1 of 47 · 1,868 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N210365-001	10092525	2035-06-17	U-2427		2018-10-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210365-001	10111840	2035-06-17	U-2443		2018-11-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210365-001	10111840	2035-06-17	U-2442		2018-11-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210365-001	10137095	2035-06-17	U-2454		2018-12-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210365-001	10137095	2035-06-17	U-2455		2018-12-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210365-001	10603288	2035-06-17	U-2780		2020-04-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210365-001	10603288	2035-06-17	U-2781		2020-04-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210365-001	10603288	2035-06-17	U-2782		2020-04-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210365-001	10603288	2035-06-17	U-2783		2020-04-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210365-001	10709671	2035-06-17	U-2862		2020-07-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210365-001	10709673	2035-06-17		Drug product	2020-07-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210365-001	10709674	2035-06-17	U-2781		2020-07-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210365-001	10709674	2035-06-17	U-2780		2020-07-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210365-001	10849860	2035-06-17	U-2427		2020-11-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210365-001	10849860	2035-06-17	U-2454		2020-11-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210365-001	10966939	2035-06-17	U-2780	Drug product	2021-04-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210365-001	10966939	2035-06-17	U-2781	Drug product	2021-04-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210365-001	11154516	2035-06-17	U-3235		2021-11-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210365-001	11154516	2035-06-17	U-3236		2021-11-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210365-001	11311498	2035-06-17	U-3375		2022-05-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210365-001	11311498	2035-06-17	U-3376		2022-05-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210365-001	11357741	2035-06-17	U-2862		2022-07-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210365-001	11446258	2035-06-17	U-2780		2022-10-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210365-001	11446258	2035-06-17	U-2781		2022-10-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210365-001	11446258	2035-06-17	U-3071		2022-10-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210365-001	11633369	2035-06-17	U-2780	Drug product	2023-05-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210365-001	11633369	2035-06-17	U-3071	Drug product	2023-05-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210365-001	11633369	2035-06-17	U-2781	Drug product	2023-05-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210365-001	11701330	2035-06-17	U-2780		2023-08-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210365-001	11701330	2035-06-17	U-2781		2023-08-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210365-001	11766411	2035-06-17	U-2781		2023-10-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210365-001	11963937	2035-06-17	U-2780		2024-05-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210365-001	11963937	2035-06-17	U-2781		2024-05-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210365-001	12064399	2035-06-17	U-3988		2024-09-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210365-001	12064399	2035-06-17	U-3989		2024-09-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210365-001	9949937	2035-06-17	U-2421		2018-10-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210365-001	9956183	2035-06-17	U-2422		2018-10-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210365-001	9956183	2035-06-17	U-2423		2018-10-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210365-001	9956184	2035-06-17	U-2424		2018-10-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210365-001	9956185	2035-06-17	U-2425		2018-10-25	`84e616aacf4f…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 5 · 175 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-09-14 22:38:34	2026-08	N210365-001	M-270	2026-10-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210365-001	ODE-326	2027-07-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210365-001	ODE-332	2027-07-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N210365-001	M-270	2026-10-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210365-001	ODE-326	2027-07-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210365-001	ODE-332	2027-07-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N210365-001	M-270	2026-10-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210365-001	ODE-326	2027-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210365-001	ODE-332	2027-07-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210365-001	ODE-216	2025-09-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210365-001	M-270	2026-10-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210365-001	ODE-326	2027-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210365-001	ODE-332	2027-07-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N210365-001	ODE-216	2025-09-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210365-001	M-270	2026-10-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210365-001	ODE-326	2027-07-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210365-001	ODE-332	2027-07-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210365-001	ODE-216	2025-09-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210365-001	M-270	2026-10-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210365-001	ODE-326	2027-07-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210365-001	ODE-332	2027-07-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210365-001	ODE-216	2025-09-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210365-001	M-270	2026-10-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210365-001	ODE-326	2027-07-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210365-001	ODE-332	2027-07-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210365-001	ODE-216	2025-09-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210365-001	M-270	2026-10-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210365-001	ODE-326	2027-07-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210365-001	ODE-332	2027-07-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210365-001	ODE-216	2025-09-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210365-001	M-270	2026-10-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210365-001	ODE-326	2027-07-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210365-001	ODE-332	2027-07-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210365-001	ODE-216	2025-09-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210365-001	M-270	2026-10-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210365-001	ODE-326	2027-07-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210365-001	ODE-332	2027-07-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210365-001	ODE-216	2025-09-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210365-001	M-270	2026-10-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210365-001	ODE-326	2027-07-31	`d8e5a09893c0…`

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
Epidiolex	CANNABIDIOL	Jazz Pharmaceuticals, Inc.	8bf27097-4870-43fb-94f0-f3d0871d1eec	2026-05-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 210365 application number: NDA210365 ndc (product): 70127-100

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70127-100	Epidiolex	cannabidiol	Greenwich Biosciences, Inc.	NDA	Current
70127-100	Epidiolex	cannabidiol	Greenwich Biosciences, Inc.	NDA	Current
70127-100	Epidiolex	cannabidiol	Greenwich Biosciences, Inc.	NDA	Current
70127-100	Epidiolex	cannabidiol	Greenwich Biosciences, Inc.	NDA	Current
70127-100	Epidiolex	cannabidiol	Greenwich Biosciences, Inc.	NDA	Current
70127-100	Epidiolex	cannabidiol	Greenwich Biosciences, Inc.	NDA	Current
70127-100	Epidiolex	cannabidiol	Greenwich Biosciences, Inc.	NDA	Current
70127-100	Epidiolex	cannabidiol	Greenwich Biosciences, Inc.	NDA	Current
70127-100	Epidiolex	cannabidiol	Greenwich Biosciences, LLC	NDA	Current
70127-100	Epidiolex	cannabidiol	Jazz Pharmaceuticals, Inc.	NDA	Current
70127-100	Epidiolex	cannabidiol	Greenwich Biosciences, Inc.	NDA	Current
70127-100	Epidiolex	cannabidiol	Greenwich Biosciences, Inc.	NDA	Current
70127-100	Epidiolex	cannabidiol	Greenwich Biosciences, Inc.	NDA	Current
70127-100	Epidiolex	cannabidiol	Greenwich Biosciences, Inc.	NDA	Current
70127-100	Epidiolex	cannabidiol	Greenwich Biosciences, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82684	SUPPL	2025-06-27
82683	SUPPL	2025-06-27
82677	SUPPL	2025-06-27
77726	SUPPL	2024-03-06
77717	SUPPL	2024-03-05
75916	SUPPL	2023-10-24
75894	SUPPL	2023-10-24
70279	SUPPL	2022-02-28
70278	SUPPL	2022-02-28
70272	SUPPL	2022-02-28
68914	ORIG	2021-10-07
68870	SUPPL	2021-10-04
68869	SUPPL	2021-10-04
68859	SUPPL	2021-10-01
68858	SUPPL	2021-10-01
68857	SUPPL	2021-10-01
68779	SUPPL	2021-09-24
68738	SUPPL	2021-09-23
65018	SUPPL	2020-10-23
65017	SUPPL	2020-10-23
64994	SUPPL	2020-10-23
64176	SUPPL	2020-08-03
64175	SUPPL	2020-08-03
64174	SUPPL	2020-08-03
64166	SUPPL	2020-08-03
64165	SUPPL	2020-08-03
64164	SUPPL	2020-08-03
64163	SUPPL	2020-08-03
58198	SUPPL	2019-04-03
58197	SUPPL	2019-04-03
56914	SUPPL	2018-12-21
55018	ORIG	2018-07-27
54681	ORIG	2018-06-25
54680	ORIG	2018-06-25
54679	ORIG	2018-06-25