Application 211367

Type: NDA
Sponsor: EXELTIS USA INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SLYND	DROSPIRENONE	TABLET;ORAL	4MG	Yes	Yes

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
N211367-001	SLYND	DROSPIRENONE	4MG	TABLET / ORAL		RLD, RS	2019-05-23

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
N211367-001	10179140	2031-06-28	U-2553		2019-06-24
N211367-001	10603281	2031-06-28	U-2553		2020-04-03
N211367-001	10849857	2031-06-28	U-2553	Drug product	2020-12-08
N211367-001	10987364	2031-06-28		Drug product	2021-04-30
N211367-001	11123299	2031-06-28		Drug product	2021-10-04
N211367-001	11291632	2031-06-28		Drug product	2022-04-11
N211367-001	11291633	2031-06-28		Drug product	2022-04-11
N211367-001	11351122	2031-06-28		Drug product	2022-06-09
N211367-001	11413249	2031-06-28	U-2553		2022-08-22
N211367-001	11478487	2031-06-28		Drug product	2022-11-04
N211367-001	11504334	2031-06-28		Drug product	2022-12-16
N211367-001	11951213	2031-06-28	U-2553		2024-04-25
N211367-001	12090231	2031-06-28	U-2553		2024-10-09
N211367-001	12280151	2031-06-28		Drug product	2025-05-08
N211367-001	9603860	2031-06-28	U-2553		2019-07-03

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 · 41 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	N211367-001	SLYND	4MG	TABLET / ORAL		RLD, RS	2019-05-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211367-001	SLYND	4MG	TABLET / ORAL		RLD, RS	2019-05-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211367-001	SLYND	4MG	TABLET / ORAL		RLD, RS	2019-05-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211367-001	SLYND	4MG	TABLET / ORAL		RLD, RS	2019-05-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211367-001	SLYND	4MG	TABLET / ORAL		RLD, RS	2019-05-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211367-001	SLYND	4MG	TABLET / ORAL		RLD, RS	2019-05-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211367-001	SLYND	4MG	TABLET / ORAL	AB	RLD, RS	2019-05-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211367-001	SLYND	4MG	TABLET / ORAL		RLD, RS	2019-05-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211367-001	SLYND	4MG	TABLET / ORAL	AB	RLD, RS	2019-05-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N211367-001	SLYND	4MG	TABLET / ORAL	AB	RLD, RS	2019-05-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211367-001	SLYND	4MG	TABLET / ORAL		RLD, RS	2019-05-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211367-001	SLYND	4MG	TABLET / ORAL		RLD, RS	2019-05-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211367-001	SLYND	4MG	TABLET / ORAL		RLD, RS	2019-05-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N211367-001	SLYND	4MG	TABLET / ORAL		RLD, RS	2019-05-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N211367-001	SLYND	4MG	TABLET / ORAL		RLD, RS	2019-05-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N211367-001	SLYND	4MG	TABLET / ORAL		RLD, RS	2019-05-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N211367-001	SLYND	4MG	TABLET / ORAL		RLD, RS	2019-05-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N211367-001	SLYND	4MG	TABLET / ORAL		RLD, RS	2019-05-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N211367-001	SLYND	4MG	TABLET / ORAL		RLD, RS	2019-05-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N211367-001	SLYND	4MG	TABLET / ORAL		RLD, RS	2019-05-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N211367-001	SLYND	4MG	TABLET / ORAL		RLD, RS	2019-05-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N211367-001	SLYND	4MG	TABLET / ORAL		RLD, RS	2019-05-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N211367-001	SLYND	4MG	TABLET / ORAL		RLD, RS	2019-05-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N211367-001	SLYND	4MG	TABLET / ORAL		RLD, RS	2019-05-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N211367-001	SLYND	4MG	TABLET / ORAL		RLD, RS	2019-05-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N211367-001	SLYND	4MG	TABLET / ORAL		RLD, RS	2019-05-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N211367-001	SLYND	4MG	TABLET / ORAL		RLD, RS	2019-05-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N211367-001	SLYND	4MG	TABLET / ORAL		RLD, RS	2019-05-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N211367-001	SLYND	4MG	TABLET / ORAL		RLD, RS	2019-05-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N211367-001	SLYND	4MG	TABLET / ORAL		RLD, RS	2019-05-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N211367-001	SLYND	4MG	TABLET / ORAL		RLD, RS	2019-05-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N211367-001	SLYND	4MG	TABLET / ORAL		RLD, RS	2019-05-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N211367-001	SLYND	4MG	TABLET / ORAL		RLD, RS	2019-05-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N211367-001	SLYND	4MG	TABLET / ORAL		RLD, RS	2019-05-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N211367-001	SLYND	4MG	TABLET / ORAL		RLD, RS	2019-05-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N211367-001	SLYND	4MG	TABLET / ORAL		RLD, RS	2019-05-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N211367-001	SLYND	4MG	TABLET / ORAL		RLD, RS	2019-05-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N211367-001	SLYND	4MG	TABLET / ORAL		RLD, RS	2019-05-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N211367-001	SLYND	4MG	TABLET / ORAL		RLD, RS	2019-05-23	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N211367-001	SLYND	4MG	TABLET / ORAL		RLD, RS	2019-05-23	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211367-001	AB	1	`2680178bc6a6…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211367-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N211367-001	AB	1	`d06236e962d9…`

Observed Orange Book patent history#

Patent history page 1 of 11 · 434 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	N211367-001	10179140	2031-06-28	U-2553		2019-06-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211367-001	10603281	2031-06-28	U-2553		2020-04-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211367-001	10849857	2031-06-28	U-2553	Drug product	2020-12-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211367-001	10987364	2031-06-28		Drug product	2021-04-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211367-001	11123299	2031-06-28		Drug product	2021-10-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211367-001	11291632	2031-06-28		Drug product	2022-04-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211367-001	11291633	2031-06-28		Drug product	2022-04-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211367-001	11351122	2031-06-28		Drug product	2022-06-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211367-001	11413249	2031-06-28	U-2553		2022-08-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211367-001	11478487	2031-06-28		Drug product	2022-11-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211367-001	11504334	2031-06-28		Drug product	2022-12-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211367-001	11951213	2031-06-28	U-2553		2024-04-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211367-001	12090231	2031-06-28	U-2553		2024-10-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211367-001	12280151	2031-06-28		Drug product	2025-05-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211367-001	9603860	2031-06-28	U-2553		2019-07-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211367-001	10179140	2031-06-28	U-2553		2019-06-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211367-001	10603281	2031-06-28	U-2553		2020-04-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211367-001	10849857	2031-06-28	U-2553	Drug product	2020-12-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211367-001	10987364	2031-06-28		Drug product	2021-04-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211367-001	11123299	2031-06-28		Drug product	2021-10-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211367-001	11291632	2031-06-28		Drug product	2022-04-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211367-001	11291633	2031-06-28		Drug product	2022-04-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211367-001	11351122	2031-06-28		Drug product	2022-06-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211367-001	11413249	2031-06-28	U-2553		2022-08-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211367-001	11478487	2031-06-28		Drug product	2022-11-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211367-001	11504334	2031-06-28		Drug product	2022-12-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211367-001	11951213	2031-06-28	U-2553		2024-04-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211367-001	12090231	2031-06-28	U-2553		2024-10-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211367-001	12280151	2031-06-28		Drug product	2025-05-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211367-001	9603860	2031-06-28	U-2553		2019-07-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211367-001	10179140	2031-06-28	U-2553		2019-06-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211367-001	10603281	2031-06-28	U-2553		2020-04-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211367-001	10849857	2031-06-28	U-2553	Drug product	2020-12-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211367-001	10987364	2031-06-28		Drug product	2021-04-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211367-001	11123299	2031-06-28		Drug product	2021-10-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211367-001	11291632	2031-06-28		Drug product	2022-04-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211367-001	11291633	2031-06-28		Drug product	2022-04-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211367-001	11351122	2031-06-28		Drug product	2022-06-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211367-001	11413249	2031-06-28	U-2553		2022-08-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211367-001	11478487	2031-06-28		Drug product	2022-11-04	`6a471c1ec25d…`

Observed Orange Book exclusivity history#

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	N211367-001	NP	2022-05-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N211367-001	NP	2022-05-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N211367-001	NP	2022-05-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N211367-001	NP	2022-05-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N211367-001	NP	2022-05-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N211367-001	NP	2022-05-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N211367-001	NP	2022-05-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N211367-001	NP	2022-05-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N211367-001	NP	2022-05-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N211367-001	NP	2022-05-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N211367-001	NP	2022-05-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N211367-001	NP	2022-05-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N211367-001	NP	2022-05-23	`ea99ee380514…`
2023-01-26 05:58 UTC	2023-01	N211367-001	NP	2022-05-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N211367-001	NP	2022-05-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N211367-001	NP	2022-05-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N211367-001	NP	2022-05-23	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N211367-001	NP	2022-05-23	`cb3db0bc1861…`

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
SLYND	DROSPIRENONE	Exeltis USA, Inc.	db32bc55-f295-4d87-9dbb-0a2f45573dcf	2025-07-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 211367 application number: NDA211367 ndc (product): 0642-7470

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0642-7470	SLYND	Drospirenone	Exeltis USA, Inc.	NDA	Current
0642-7470	SLYND	Drospirenone	Exeltis USA, Inc.	NDA	Current
0642-7470	SLYND	Drospirenone	Exeltis USA, Inc.	NDA	Current
0642-7470	SLYND	Drospirenone	Exeltis USA, Inc.	NDA	Current
0642-7470	SLYND	Drospirenone	Exeltis USA, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
61865	ORIG	2020-02-11
58859	ORIG	2019-05-24
58850	ORIG	2019-05-24
62970	ORIG	1900-01-01