Application 214154

Type: NDA
Sponsor: MAYNE PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NEXTSTELLIS	DROSPIRENONE;ESTETROL	TABLET, CHEWABLE, TABLET, CAPSULE; ORAL	3MG;14.2MG	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
N214154-001	NEXTSTELLIS	DROSPIRENONE; ESTETROL	3MG;14.2MG	TABLET / ORAL		RLD, RS	2021-04-15

Orange Book patents#

Current patent rows page 1 of 1 · 7 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N214154-001	7732430	2028-01-15	U-3152	Drug product	2021-04-30
N214154-001	11793760	2036-06-17		Drug product	2023-10-31
N214154-001	11957694	2036-06-17		Drug product	2024-04-29
N214154-001	11964055	2036-06-17		Drug product	2024-04-29
N214154-001	12427114	2036-06-17	U-3152	Drug product	2025-10-16
N214154-001	12233074	2043-02-09	U-3152	Drug product	2025-03-06
N214154-001	12458649	2043-10-01	U-3152		2025-11-06

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N214154-001	NCE	2026-04-15

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	N214154-001	NEXTSTELLIS	3MG;14.2MG	TABLET / ORAL	RLD, RS	2021-04-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214154-001	NEXTSTELLIS	3MG;14.2MG	TABLET / ORAL	RLD, RS	2021-04-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214154-001	NEXTSTELLIS	3MG;14.2MG	TABLET / ORAL	RLD, RS	2021-04-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214154-001	NEXTSTELLIS	3MG;14.2MG	TABLET / ORAL	RLD, RS	2021-04-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214154-001	NEXTSTELLIS	3MG;14.2MG	TABLET / ORAL	RLD, RS	2021-04-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214154-001	NEXTSTELLIS	3MG;14.2MG	TABLET / ORAL	RLD, RS	2021-04-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214154-001	NEXTSTELLIS	3MG;14.2MG	TABLET / ORAL	RLD, RS	2021-04-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214154-001	NEXTSTELLIS	3MG;14.2MG	TABLET / ORAL	RLD, RS	2021-04-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214154-001	NEXTSTELLIS	3MG;14.2MG	TABLET / ORAL	RLD, RS	2021-04-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214154-001	NEXTSTELLIS	3MG;14.2MG	TABLET / ORAL	RLD, RS	2021-04-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214154-001	NEXTSTELLIS	3MG;14.2MG	TABLET / ORAL	RLD, RS	2021-04-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214154-001	NEXTSTELLIS	3MG;14.2MG	TABLET / ORAL	RLD, RS	2021-04-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214154-001	NEXTSTELLIS	3MG;14.2MG	TABLET / ORAL	RLD, RS	2021-04-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N214154-001	NEXTSTELLIS	3MG;14.2MG	TABLET / ORAL	RLD, RS	2021-04-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N214154-001	NEXTSTELLIS	3MG;14.2MG	TABLET / ORAL	RLD, RS	2021-04-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N214154-001	NEXTSTELLIS	3MG;14.2MG	TABLET / ORAL	RLD, RS	2021-04-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N214154-001	NEXTSTELLIS	3MG;14.2MG	TABLET / ORAL	RLD, RS	2021-04-15	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N214154-001	NEXTSTELLIS	3MG;14.2MG	TABLET / ORAL	RLD, RS	2021-04-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N214154-001	NEXTSTELLIS	3MG;14.2MG	TABLET / ORAL	RLD, RS	2021-04-15	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N214154-001	NEXTSTELLIS	3MG;14.2MG	TABLET / ORAL	RLD, RS	2021-04-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N214154-001	NEXTSTELLIS	3MG;14.2MG	TABLET / ORAL	RLD, RS	2021-04-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N214154-001	NEXTSTELLIS	3MG;14.2MG	TABLET / ORAL	RLD, RS	2021-04-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N214154-001	NEXTSTELLIS	3MG;14.2MG	TABLET / ORAL	RLD, RS	2021-04-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N214154-001	NEXTSTELLIS	3MG;14.2MG	TABLET / ORAL	RLD, RS	2021-04-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N214154-001	NEXTSTELLIS	3MG;14.2MG	TABLET / ORAL	RLD, RS	2021-04-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N214154-001	NEXTSTELLIS	3MG;14.2MG	TABLET / ORAL	RLD, RS	2021-04-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N214154-001	NEXTSTELLIS	3MG;14.2MG	TABLET / ORAL	RLD, RS	2021-04-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N214154-001	NEXTSTELLIS	3MG;14.2MG	TABLET / ORAL	RLD, RS	2021-04-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N214154-001	NEXTSTELLIS	3MG;14.2MG	TABLET / ORAL	RLD, RS	2021-04-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N214154-001	NEXTSTELLIS	3MG;14.2MG	TABLET / ORAL	RLD, RS	2021-04-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N214154-001	NEXTSTELLIS	3MG;14.2MG	TABLET / ORAL	RLD, RS	2021-04-15	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N214154-001	NEXTSTELLIS	3MG;14.2MG	TABLET / ORAL	RLD, RS	2021-04-15	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N214154-001	NEXTSTELLIS	3MG;14.2MG	TABLET / ORAL	RLD, RS	2021-04-15	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 93 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	N214154-001	7732430	2028-01-15	U-3152	Drug product	2021-04-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214154-001	11793760	2036-06-17		Drug product	2023-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214154-001	11957694	2036-06-17		Drug product	2024-04-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214154-001	11964055	2036-06-17		Drug product	2024-04-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214154-001	12427114	2036-06-17	U-3152	Drug product	2025-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214154-001	12233074	2043-02-09	U-3152	Drug product	2025-03-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214154-001	12458649	2043-10-01	U-3152		2025-11-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214154-001	7732430	2028-01-15	U-3152	Drug product	2021-04-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214154-001	11793760	2036-06-17		Drug product	2023-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214154-001	11957694	2036-06-17		Drug product	2024-04-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214154-001	11964055	2036-06-17		Drug product	2024-04-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214154-001	12427114	2036-06-17	U-3152	Drug product	2025-10-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214154-001	12233074	2043-02-09	U-3152	Drug product	2025-03-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214154-001	12458649	2043-10-01	U-3152		2025-11-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214154-001	7732430	2028-01-15	U-3152	Drug product	2021-04-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214154-001	11793760	2036-06-17		Drug product	2023-10-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214154-001	11957694	2036-06-17		Drug product	2024-04-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214154-001	11964055	2036-06-17		Drug product	2024-04-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214154-001	12233074	2043-02-09	U-3152	Drug product	2025-03-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214154-001	7732430	2026-03-02	U-3152	Drug product	2021-04-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214154-001	11793760	2036-06-17		Drug product	2023-10-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214154-001	11957694	2036-06-17		Drug product	2024-04-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214154-001	11964055	2036-06-17		Drug product	2024-04-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214154-001	12233074	2043-02-09	U-3152	Drug product	2025-03-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214154-001	7732430	2026-03-02	U-3152	Drug product	2021-04-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214154-001	11793760	2036-06-17		Drug product	2023-10-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214154-001	11957694	2036-06-17		Drug product	2024-04-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214154-001	11964055	2036-06-17		Drug product	2024-04-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214154-001	7732430	2026-03-02	U-3152	Drug product	2021-04-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214154-001	11793760	2036-06-17		Drug product	2023-10-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214154-001	11957694	2036-06-17		Drug product	2024-04-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214154-001	11964055	2036-06-17		Drug product	2024-04-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214154-001	7732430	2026-03-02	U-3152	Drug product	2021-04-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214154-001	11793760	2036-06-17		Drug product	2023-10-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214154-001	11957694	2036-06-17		Drug product	2024-04-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214154-001	11964055	2036-06-17		Drug product	2024-04-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214154-001	7732430	2025-03-02	U-3152	Drug product	2021-04-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214154-001	11793760	2036-06-17		Drug product	2023-10-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214154-001	11957694	2036-06-17		Drug product	2024-04-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214154-001	11964055	2036-06-17		Drug product	2024-04-29	`5bbf6a4d5a75…`

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	N214154-001	NCE	2026-04-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214154-001	NCE	2026-04-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214154-001	NCE	2026-04-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214154-001	NCE	2026-04-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214154-001	NCE	2026-04-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214154-001	NCE	2026-04-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214154-001	NCE	2026-04-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214154-001	NCE	2026-04-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214154-001	NCE	2026-04-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214154-001	NCE	2026-04-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214154-001	NCE	2026-04-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214154-001	NCE	2026-04-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214154-001	NCE	2026-04-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N214154-001	NCE	2026-04-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N214154-001	NCE	2026-04-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N214154-001	NCE	2026-04-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N214154-001	NCE	2026-04-15	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N214154-001	NCE	2026-04-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N214154-001	NCE	2026-04-15	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N214154-001	NCE	2026-04-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N214154-001	NCE	2026-04-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N214154-001	NCE	2026-04-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N214154-001	NCE	2026-04-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N214154-001	NCE	2026-04-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N214154-001	NCE	2026-04-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N214154-001	NCE	2026-04-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N214154-001	NCE	2026-04-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N214154-001	NCE	2026-04-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N214154-001	NCE	2026-04-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N214154-001	NCE	2026-04-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N214154-001	NCE	2026-04-15	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N214154-001	NCE	2026-04-15	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N214154-001	NCE	2026-04-15	`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
Nextstellis	DROSPIRENONE AND ESTETROL	Mayne Pharma	c5270073-d083-4109-ae4b-156986175e0a	2023-05-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 214154 application number: NDA214154 ndc (product): 51862-258

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
51862-258	Nextstellis	drospirenone and estetrol	Mayne Pharma	NDA	Current
51862-258	Nextstellis	drospirenone and estetrol	Mayne Pharma	NDA	Current
51862-258	Nextstellis	drospirenone and estetrol	Mayne Pharma	NDA	Current
51862-258	Nextstellis	drospirenone and estetrol	Mayne Pharma	NDA	Current
51862-258	Nextstellis	drospirenone and estetrol	Mayne Pharma	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
70956	SUPPL	2022-05-03
70906	SUPPL	2022-05-02
67459	ORIG	2021-05-12
67081	ORIG	2021-04-16
67062	ORIG	2021-04-15