Application 216285

Type: NDA
Sponsor: EXELTIS USA INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DROSPIRENONE	DROSPIRENONE	TABLET, CHEWABLE;ORAL	3.5MG	No	No

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
N216285-001	DROSPIRENONE	DROSPIRENONE	3.5MG	TABLET, CHEWABLE / ORAL		RLD	2022-06-29

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
N216285-001	10179140	2031-06-28	U-2553		2022-07-13
N216285-001	10603281	2031-06-28	U-2553		2022-07-13
N216285-001	10849857	2031-06-28	U-2553	Drug product	2022-07-13
N216285-001	10987364	2031-06-28		Drug product	2022-07-13
N216285-001	11123299	2031-06-28		Drug product	2022-07-13
N216285-001	11291632	2031-06-28		Drug product	2022-07-13
N216285-001	11291633	2031-06-28		Drug product	2022-07-13
N216285-001	11351122	2031-06-28		Drug product	2022-07-13
N216285-001	11413249	2031-06-28	U-2553		2022-08-22
N216285-001	11439598	2031-06-28		Drug product	2022-09-21
N216285-001	11478487	2031-06-28		Drug product	2022-11-04
N216285-001	11504334	2031-06-28		Drug product	2022-12-16
N216285-001	11951213	2031-06-28	U-2553		2024-04-25
N216285-001	12090231	2031-06-28	U-2553		2024-10-09
N216285-001	9603860	2031-06-28	U-2553		2022-07-13

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
2026-09-14 22:38:34	2026-08	N216285-001	DROSPIRENONE	3.5MG	TABLET, CHEWABLE / ORAL	RLD	2022-06-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N216285-001	DROSPIRENONE	3.5MG	TABLET, CHEWABLE / ORAL	RLD	2022-06-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N216285-001	DROSPIRENONE	3.5MG	TABLET, CHEWABLE / ORAL	RLD	2022-06-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216285-001	DROSPIRENONE	3.5MG	TABLET, CHEWABLE / ORAL	RLD	2022-06-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N216285-001	DROSPIRENONE	3.5MG	TABLET, CHEWABLE / ORAL	RLD	2022-06-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216285-001	DROSPIRENONE	3.5MG	TABLET, CHEWABLE / ORAL	RLD	2022-06-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216285-001	DROSPIRENONE	3.5MG	TABLET, CHEWABLE / ORAL	RLD	2022-06-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216285-001	DROSPIRENONE	3.5MG	TABLET, CHEWABLE / ORAL	RLD	2022-06-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216285-001	DROSPIRENONE	3.5MG	TABLET, CHEWABLE / ORAL	RLD	2022-06-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216285-001	DROSPIRENONE	3.5MG	TABLET, CHEWABLE / ORAL	RLD	2022-06-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216285-001	DROSPIRENONE	3.5MG	TABLET, CHEWABLE / ORAL	RLD	2022-06-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N216285-001	DROSPIRENONE	3.5MG	TABLET, CHEWABLE / ORAL	RLD	2022-06-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N216285-001	DROSPIRENONE	3.5MG	TABLET, CHEWABLE / ORAL	RLD	2022-06-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N216285-001	DROSPIRENONE	3.5MG	TABLET, CHEWABLE / ORAL	RLD	2022-06-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N216285-001	DROSPIRENONE	3.5MG	TABLET, CHEWABLE / ORAL	RLD	2022-06-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N216285-001	DROSPIRENONE	3.5MG	TABLET, CHEWABLE / ORAL	RLD	2022-06-29	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N216285-001	DROSPIRENONE	3.5MG	TABLET, CHEWABLE / ORAL	RLD	2022-06-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N216285-001	DROSPIRENONE	3.5MG	TABLET, CHEWABLE / ORAL	RLD	2022-06-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N216285-001	DROSPIRENONE	3.5MG	TABLET, CHEWABLE / ORAL	RLD	2022-06-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N216285-001	DROSPIRENONE	3.5MG	TABLET, CHEWABLE / ORAL	RLD	2022-06-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N216285-001	DROSPIRENONE	3.5MG	TABLET, CHEWABLE / ORAL	RLD	2022-06-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N216285-001	DROSPIRENONE	3.5MG	TABLET, CHEWABLE / ORAL	RLD	2022-06-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N216285-001	DROSPIRENONE	3.5MG	TABLET, CHEWABLE / ORAL	RLD, RS	2022-06-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N216285-001	DROSPIRENONE	3.5MG	TABLET, CHEWABLE / ORAL	RLD, RS	2022-06-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N216285-001	DROSPIRENONE	3.5MG	TABLET, CHEWABLE / ORAL	RLD, RS	2022-06-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N216285-001	DROSPIRENONE	3.5MG	TABLET, CHEWABLE / ORAL	RLD, RS	2022-06-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N216285-001	DROSPIRENONE	3.5MG	TABLET, CHEWABLE / ORAL	RLD, RS	2022-06-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N216285-001	DROSPIRENONE	3.5MG	TABLET, CHEWABLE / ORAL	RLD, RS	2022-06-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N216285-001	DROSPIRENONE	3.5MG	TABLET, CHEWABLE / ORAL	RLD, RS	2022-06-29	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216285-001	DROSPIRENONE	3.5MG	TABLET, CHEWABLE / ORAL	RLD	2022-06-29	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 10 · 400 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	N216285-001	10179140	2031-06-28	U-2553		2022-07-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216285-001	10603281	2031-06-28	U-2553		2022-07-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216285-001	10849857	2031-06-28	U-2553	Drug product	2022-07-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216285-001	10987364	2031-06-28		Drug product	2022-07-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216285-001	11123299	2031-06-28		Drug product	2022-07-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216285-001	11291632	2031-06-28		Drug product	2022-07-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216285-001	11291633	2031-06-28		Drug product	2022-07-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216285-001	11351122	2031-06-28		Drug product	2022-07-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216285-001	11413249	2031-06-28	U-2553		2022-08-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216285-001	11439598	2031-06-28		Drug product	2022-09-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216285-001	11478487	2031-06-28		Drug product	2022-11-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216285-001	11504334	2031-06-28		Drug product	2022-12-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216285-001	11951213	2031-06-28	U-2553		2024-04-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216285-001	12090231	2031-06-28	U-2553		2024-10-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216285-001	9603860	2031-06-28	U-2553		2022-07-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N216285-001	10179140	2031-06-28	U-2553		2022-07-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216285-001	10603281	2031-06-28	U-2553		2022-07-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216285-001	10849857	2031-06-28	U-2553	Drug product	2022-07-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216285-001	10987364	2031-06-28		Drug product	2022-07-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216285-001	11123299	2031-06-28		Drug product	2022-07-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216285-001	11291632	2031-06-28		Drug product	2022-07-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216285-001	11291633	2031-06-28		Drug product	2022-07-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216285-001	11351122	2031-06-28		Drug product	2022-07-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216285-001	11413249	2031-06-28	U-2553		2022-08-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216285-001	11439598	2031-06-28		Drug product	2022-09-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216285-001	11478487	2031-06-28		Drug product	2022-11-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216285-001	11504334	2031-06-28		Drug product	2022-12-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216285-001	11951213	2031-06-28	U-2553		2024-04-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216285-001	12090231	2031-06-28	U-2553		2024-10-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216285-001	9603860	2031-06-28	U-2553		2022-07-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N216285-001	10179140	2031-06-28	U-2553		2022-07-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216285-001	10603281	2031-06-28	U-2553		2022-07-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216285-001	10849857	2031-06-28	U-2553	Drug product	2022-07-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216285-001	10987364	2031-06-28		Drug product	2022-07-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216285-001	11123299	2031-06-28		Drug product	2022-07-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216285-001	11291632	2031-06-28		Drug product	2022-07-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216285-001	11291633	2031-06-28		Drug product	2022-07-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216285-001	11351122	2031-06-28		Drug product	2022-07-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216285-001	11413249	2031-06-28	U-2553		2022-08-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216285-001	11439598	2031-06-28		Drug product	2022-09-21	`011fe1cb6892…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216285-001	NP	2025-06-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N216285-001	NP	2025-06-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216285-001	NP	2025-06-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216285-001	NP	2025-06-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216285-001	NP	2025-06-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216285-001	NP	2025-06-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216285-001	NP	2025-06-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216285-001	NP	2025-06-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N216285-001	NP	2025-06-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N216285-001	NP	2025-06-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N216285-001	NP	2025-06-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N216285-001	NP	2025-06-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N216285-001	NP	2025-06-29	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N216285-001	NP	2025-06-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N216285-001	NP	2025-06-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N216285-001	NP	2025-06-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N216285-001	NP	2025-06-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N216285-001	NP	2025-06-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N216285-001	NP	2025-06-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N216285-001	NP	2025-06-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N216285-001	NP	2025-06-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N216285-001	NP	2025-06-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N216285-001	NP	2025-06-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N216285-001	NP	2025-06-29	`f41ea6bd6efb…`

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	2026-08-27	Warnings, Adverse reactions	Name fallback generic name: DROSPIRENONE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
73802	ORIG	2023-03-20
72980	SUPPL	2022-12-21
71502	ORIG	2022-06-30
71493	ORIG	2022-06-30