Application 215910

Type: NDA
Sponsor: SUN PHARMA ADVANCED RESEARCH COMPANY, LTD.

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SEZABY	PHENOBARBITAL	SOLUTION; INJECTION	100MG	No	No

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
N215910-001	SEZABY	PHENOBARBITAL SODIUM	100MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2022-11-17

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N215910-001	11857683	2042-04-07	U-3779	Drug product	2024-01-10
N215910-001	12636254	2042-04-07	U-3779	Drug product	2026-06-08

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N215910-001	ODE-414	2029-11-17

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.

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	N215910-001	SEZABY	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-11-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215910-001	SEZABY	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-11-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215910-001	SEZABY	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-11-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215910-001	SEZABY	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-11-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215910-001	SEZABY	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-11-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215910-001	SEZABY	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-11-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215910-001	SEZABY	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-11-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215910-001	SEZABY	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-11-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215910-001	SEZABY	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-11-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215910-001	SEZABY	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-11-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215910-001	SEZABY	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-11-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215910-001	SEZABY	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-11-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215910-001	SEZABY	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-11-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N215910-001	SEZABY	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-11-17	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N215910-001	SEZABY	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-11-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N215910-001	SEZABY	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-11-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N215910-001	SEZABY	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-11-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N215910-001	SEZABY	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-11-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N215910-001	SEZABY	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-11-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N215910-001	SEZABY	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-11-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N215910-001	SEZABY	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-11-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N215910-001	SEZABY	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-11-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N215910-001	SEZABY	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-11-17	`3bdfa0b2c4d7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215910-001	SEZABY	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-11-17	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N215910-001	11857683	2042-04-07	U-3779	Drug product	2024-01-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215910-001	11857683	2042-04-07	U-3779	Drug product	2024-01-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215910-001	11857683	2042-04-07	U-3779	Drug product	2024-01-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215910-001	11857683	2042-04-07	U-3779	Drug product	2024-01-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215910-001	11857683	2042-04-07	U-3779	Drug product	2024-01-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215910-001	11857683	2042-04-07	U-3779	Drug product	2024-01-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215910-001	11857683	2042-04-07	U-3779	Drug product	2024-01-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215910-001	11857683	2042-04-07	U-3779	Drug product	2024-01-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215910-001	11857683	2042-04-07	U-3779	Drug product	2024-01-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215910-001	11857683	2042-04-07	U-3779	Drug product	2024-01-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215910-001	11857683	2042-04-07	U-3779	Drug product	2024-01-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215910-001	11857683	2042-04-07	U-3779	Drug product	2024-01-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215910-001	11857683	2042-04-07	U-3779	Drug product	2024-01-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N215910-001	11857683	2042-04-07	U-3779	Drug product	2024-01-10	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N215910-001	11857683	2042-04-07	U-3779	Drug product	2024-01-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N215910-001	11857683	2042-04-07	U-3779	Drug product	2024-01-10	`1c564ffb4f44…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215910-001	11857683	2042-04-07	U-3779	Drug product	2024-01-10	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215910-001	12636254	2042-04-07	U-3779	Drug product	2026-06-08	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N215910-001	ODE-414	2029-11-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215910-001	ODE-414	2029-11-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215910-001	ODE-414	2029-11-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215910-001	ODE-414	2029-11-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215910-001	ODE-414	2029-11-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215910-001	ODE-414	2029-11-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215910-001	ODE-414	2029-11-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215910-001	ODE-414	2029-11-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215910-001	ODE-414	2029-11-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215910-001	ODE-414	2029-11-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215910-001	ODE-414	2029-11-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215910-001	ODE-414	2029-11-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215910-001	ODE-414	2029-11-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N215910-001	ODE-414	2029-11-17	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N215910-001	ODE-414	2029-11-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N215910-001	ODE-414	2029-11-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N215910-001	ODE-414	2029-11-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N215910-001	ODE-414	2029-11-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N215910-001	ODE-414	2029-11-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N215910-001	ODE-414	2029-11-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N215910-001	ODE-414	2029-11-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N215910-001	ODE-414	2029-11-17	`053a50430f4f…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215910-001	ODE-414	2029-11-17	`a50c72e98297…`

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
SEZABY	PHENOBARBITAL SODIUM	Sun Pharmaceutical Industries, Inc.	8c7d0402-4977-4c25-bc4b-11db91339e9a	2025-12-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 215910 application number: NDA215910 ndc (product): 62756-301

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
62756-301	SEZABY	phenobarbital sodium	Sun Pharmaceutical Industries, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
75115	ORIG	2023-08-18
73615	ORIG	2023-02-27
72653	ORIG	2022-11-18