Application 209521

Type: NDA
Sponsor: ALMIRALL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SEYSARA	SARECYCLINE HYDROCHLORIDE	TABLET;ORAL	EQ 60MG BASE	Yes	No
002	SEYSARA	SARECYCLINE HYDROCHLORIDE	TABLET;ORAL	EQ 100MG BASE	Yes	No
003	SEYSARA	SARECYCLINE HYDROCHLORIDE	TABLET;ORAL	EQ 150MG BASE	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N209521-001	SEYSARA	SARECYCLINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	RLD	2018-10-01
N209521-002	SEYSARA	SARECYCLINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	RLD	2018-10-01
N209521-003	SEYSARA	SARECYCLINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	RLD, RS	2018-10-01

Orange Book patents#

Current patent rows page 1 of 1 · 15 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N209521-001	9481639	2028-08-10	U-2409		2018-10-12
N209521-001	8513223	2029-12-07	U-2406		2018-10-12
N209521-001	8318706	2032-01-03	U-2405	Drug substance, Drug product	2018-10-12
N209521-001	9255068	2033-02-09	U-2407	Drug substance, Drug product	2018-10-12
N209521-001	9255068	2033-02-09	U-2408	Drug substance, Drug product	2018-10-12
N209521-002	9481639	2028-08-10	U-2409		2018-10-12
N209521-002	8513223	2029-12-07	U-2406		2018-10-12
N209521-002	8318706	2032-01-03	U-2405	Drug substance, Drug product	2018-10-12
N209521-002	9255068	2033-02-09	U-2407	Drug substance, Drug product	2018-10-12
N209521-002	9255068	2033-02-09	U-2408	Drug substance, Drug product	2018-10-12
N209521-003	9481639	2028-08-10	U-2409		2018-10-12
N209521-003	8513223	2029-12-07	U-2406		2018-10-12
N209521-003	8318706	2032-01-03	U-2405	Drug substance, Drug product	2018-10-12
N209521-003	9255068	2033-02-09	U-2407	Drug substance, Drug product	2018-10-12
N209521-003	9255068	2033-02-09	U-2408	Drug substance, Drug product	2018-10-12

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 4 · 123 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	N209521-001	SEYSARA	EQ 60MG BASE	TABLET / ORAL	RLD	2018-10-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209521-002	SEYSARA	EQ 100MG BASE	TABLET / ORAL	RLD	2018-10-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209521-003	SEYSARA	EQ 150MG BASE	TABLET / ORAL	RLD, RS	2018-10-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209521-001	SEYSARA	EQ 60MG BASE	TABLET / ORAL	RLD	2018-10-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209521-002	SEYSARA	EQ 100MG BASE	TABLET / ORAL	RLD	2018-10-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209521-003	SEYSARA	EQ 150MG BASE	TABLET / ORAL	RLD, RS	2018-10-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209521-001	SEYSARA	EQ 60MG BASE	TABLET / ORAL	RLD	2018-10-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209521-002	SEYSARA	EQ 100MG BASE	TABLET / ORAL	RLD	2018-10-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209521-003	SEYSARA	EQ 150MG BASE	TABLET / ORAL	RLD, RS	2018-10-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209521-001	SEYSARA	EQ 60MG BASE	TABLET / ORAL	RLD	2018-10-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209521-002	SEYSARA	EQ 100MG BASE	TABLET / ORAL	RLD	2018-10-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209521-003	SEYSARA	EQ 150MG BASE	TABLET / ORAL	RLD, RS	2018-10-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209521-001	SEYSARA	EQ 60MG BASE	TABLET / ORAL	RLD	2018-10-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209521-002	SEYSARA	EQ 100MG BASE	TABLET / ORAL	RLD	2018-10-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209521-003	SEYSARA	EQ 150MG BASE	TABLET / ORAL	RLD, RS	2018-10-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209521-001	SEYSARA	EQ 60MG BASE	TABLET / ORAL	RLD	2018-10-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209521-002	SEYSARA	EQ 100MG BASE	TABLET / ORAL	RLD	2018-10-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209521-003	SEYSARA	EQ 150MG BASE	TABLET / ORAL	RLD, RS	2018-10-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209521-001	SEYSARA	EQ 60MG BASE	TABLET / ORAL	RLD	2018-10-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209521-002	SEYSARA	EQ 100MG BASE	TABLET / ORAL	RLD	2018-10-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209521-003	SEYSARA	EQ 150MG BASE	TABLET / ORAL	RLD, RS	2018-10-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209521-001	SEYSARA	EQ 60MG BASE	TABLET / ORAL	RLD	2018-10-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209521-002	SEYSARA	EQ 100MG BASE	TABLET / ORAL	RLD	2018-10-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209521-003	SEYSARA	EQ 150MG BASE	TABLET / ORAL	RLD, RS	2018-10-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209521-001	SEYSARA	EQ 60MG BASE	TABLET / ORAL	RLD	2018-10-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209521-002	SEYSARA	EQ 100MG BASE	TABLET / ORAL	RLD	2018-10-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209521-003	SEYSARA	EQ 150MG BASE	TABLET / ORAL	RLD, RS	2018-10-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209521-001	SEYSARA	EQ 60MG BASE	TABLET / ORAL	RLD	2018-10-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209521-002	SEYSARA	EQ 100MG BASE	TABLET / ORAL	RLD	2018-10-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209521-003	SEYSARA	EQ 150MG BASE	TABLET / ORAL	RLD, RS	2018-10-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209521-001	SEYSARA	EQ 60MG BASE	TABLET / ORAL	RLD	2018-10-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209521-002	SEYSARA	EQ 100MG BASE	TABLET / ORAL	RLD	2018-10-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209521-003	SEYSARA	EQ 150MG BASE	TABLET / ORAL	RLD, RS	2018-10-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209521-001	SEYSARA	EQ 60MG BASE	TABLET / ORAL	RLD	2018-10-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209521-002	SEYSARA	EQ 100MG BASE	TABLET / ORAL	RLD	2018-10-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209521-003	SEYSARA	EQ 150MG BASE	TABLET / ORAL	RLD, RS	2018-10-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209521-001	SEYSARA	EQ 60MG BASE	TABLET / ORAL	RLD	2018-10-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209521-002	SEYSARA	EQ 100MG BASE	TABLET / ORAL	RLD	2018-10-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209521-003	SEYSARA	EQ 150MG BASE	TABLET / ORAL	RLD, RS	2018-10-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209521-001	SEYSARA	EQ 60MG BASE	TABLET / ORAL	RLD	2018-10-01	`8072bd15b7f6…`

Observed Orange Book patent history#

Patent history page 1 of 16 · 615 observed states.

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	N209521-001	9481639	2028-08-10	U-2409		2018-10-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209521-001	8513223	2029-12-07	U-2406		2018-10-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209521-001	8318706	2032-01-03	U-2405	Drug substance, Drug product	2018-10-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209521-001	9255068	2033-02-09	U-2407	Drug substance, Drug product	2018-10-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209521-001	9255068	2033-02-09	U-2408	Drug substance, Drug product	2018-10-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209521-002	9481639	2028-08-10	U-2409		2018-10-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209521-002	8513223	2029-12-07	U-2406		2018-10-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209521-002	8318706	2032-01-03	U-2405	Drug substance, Drug product	2018-10-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209521-002	9255068	2033-02-09	U-2408	Drug substance, Drug product	2018-10-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209521-002	9255068	2033-02-09	U-2407	Drug substance, Drug product	2018-10-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209521-003	9481639	2028-08-10	U-2409		2018-10-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209521-003	8513223	2029-12-07	U-2406		2018-10-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209521-003	8318706	2032-01-03	U-2405	Drug substance, Drug product	2018-10-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209521-003	9255068	2033-02-09	U-2408	Drug substance, Drug product	2018-10-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209521-003	9255068	2033-02-09	U-2407	Drug substance, Drug product	2018-10-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209521-001	9481639	2028-08-10	U-2409		2018-10-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209521-001	8513223	2029-12-07	U-2406		2018-10-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209521-001	8318706	2032-01-03	U-2405	Drug substance, Drug product	2018-10-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209521-001	9255068	2033-02-09	U-2407	Drug substance, Drug product	2018-10-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209521-001	9255068	2033-02-09	U-2408	Drug substance, Drug product	2018-10-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209521-002	9481639	2028-08-10	U-2409		2018-10-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209521-002	8513223	2029-12-07	U-2406		2018-10-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209521-002	8318706	2032-01-03	U-2405	Drug substance, Drug product	2018-10-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209521-002	9255068	2033-02-09	U-2408	Drug substance, Drug product	2018-10-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209521-002	9255068	2033-02-09	U-2407	Drug substance, Drug product	2018-10-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209521-003	9481639	2028-08-10	U-2409		2018-10-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209521-003	8513223	2029-12-07	U-2406		2018-10-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209521-003	8318706	2032-01-03	U-2405	Drug substance, Drug product	2018-10-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209521-003	9255068	2033-02-09	U-2408	Drug substance, Drug product	2018-10-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209521-003	9255068	2033-02-09	U-2407	Drug substance, Drug product	2018-10-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209521-001	9481639	2028-08-10	U-2409		2018-10-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209521-001	8513223	2029-12-07	U-2406		2018-10-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209521-001	8318706	2031-05-01	U-2405	Drug substance, Drug product	2018-10-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209521-001	9255068	2033-02-09	U-2407	Drug substance, Drug product	2018-10-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209521-001	9255068	2033-02-09	U-2408	Drug substance, Drug product	2018-10-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209521-002	9481639	2028-08-10	U-2409		2018-10-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209521-002	8513223	2029-12-07	U-2406		2018-10-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209521-002	8318706	2031-05-01	U-2405	Drug substance, Drug product	2018-10-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209521-002	9255068	2033-02-09	U-2408	Drug substance, Drug product	2018-10-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209521-002	9255068	2033-02-09	U-2407	Drug substance, Drug product	2018-10-12	`6a471c1ec25d…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 72 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209521-001	NCE	2023-10-01	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209521-002	NCE	2023-10-01	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209521-003	NCE	2023-10-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209521-001	NCE	2023-10-01	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N209521-002	NCE	2023-10-01	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N209521-003	NCE	2023-10-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209521-001	NCE	2023-10-01	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N209521-002	NCE	2023-10-01	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N209521-003	NCE	2023-10-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N209521-001	NCE	2023-10-01	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N209521-002	NCE	2023-10-01	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N209521-003	NCE	2023-10-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N209521-001	NCE	2023-10-01	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N209521-002	NCE	2023-10-01	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N209521-003	NCE	2023-10-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N209521-001	NCE	2023-10-01	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N209521-002	NCE	2023-10-01	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N209521-003	NCE	2023-10-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209521-001	NCE	2023-10-01	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209521-002	NCE	2023-10-01	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209521-003	NCE	2023-10-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N209521-001	NCE	2023-10-01	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N209521-002	NCE	2023-10-01	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N209521-003	NCE	2023-10-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N209521-001	NCE	2023-10-01	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N209521-002	NCE	2023-10-01	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N209521-003	NCE	2023-10-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N209521-001	NCE	2023-10-01	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N209521-002	NCE	2023-10-01	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N209521-003	NCE	2023-10-01	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N209521-001	NCE	2023-10-01	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N209521-002	NCE	2023-10-01	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N209521-003	NCE	2023-10-01	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N209521-001	NCE	2023-10-01	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N209521-002	NCE	2023-10-01	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N209521-003	NCE	2023-10-01	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N209521-001	NCE	2023-10-01	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N209521-002	NCE	2023-10-01	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N209521-003	NCE	2023-10-01	`ea99ee380514…`
2023-12-20 04:57 UTC	2023-12	N209521-001	NCE	2023-10-01	`ea1830bbd6c7…`

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
Seysara	SARECYCLINE HYDROCHLORIDE	Almirall, LLC	b200957c-3004-4988-be97-9fd619a83649	2024-06-05	Warnings, Adverse reactions	Exact identifier application applno (NDA): 209521 application number: NDA209521 ndc (product): 16110-246 ndc (product): 16110-245 ndc (product): 16110-247

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16110-245	Seysara	sarecycline hydrochloride	Almirall, LLC	NDA	Current
16110-245	Seysara	sarecycline hydrochloride	Almirall, LLC	NDA	Current
16110-245	Seysara	sarecycline hydrochloride	Almirall, LLC	NDA	Current
16110-245	Seysara	sarecycline hydrochloride	Almirall, LLC	NDA	Current
16110-246	Seysara	sarecycline hydrochloride	Almirall, LLC	NDA	Current
16110-246	Seysara	sarecycline hydrochloride	Almirall, LLC	NDA	Current
16110-246	Seysara	sarecycline hydrochloride	Almirall, LLC	NDA	Current
16110-246	Seysara	sarecycline hydrochloride	Almirall, LLC	NDA	Current
16110-247	Seysara	sarecycline hydrochloride	Almirall, LLC	NDA	Current
16110-247	Seysara	sarecycline hydrochloride	Almirall, LLC	NDA	Current
16110-247	Seysara	sarecycline hydrochloride	Almirall, LLC	NDA	Current
16110-247	Seysara	sarecycline hydrochloride	Almirall, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
73918	SUPPL	2023-03-31
73917	SUPPL	2023-03-31
73914	SUPPL	2023-03-31
73913	SUPPL	2023-03-31
63404	SUPPL	2020-06-02
63402	SUPPL	2020-06-02
58275	SUPPL	2019-04-10
58268	SUPPL	2019-04-10
56012	ORIG	2018-10-18
55785	ORIG	2018-10-02
55784	ORIG	2018-10-01
63265	ORIG	1900-01-01