Application 208470

Type: NDA
Sponsor: AMAG PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	INTRAROSA	PRASTERONE	INSERT;VAGINAL	6.5MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N208470-001	INTRAROSA	PRASTERONE	6.5MG	INSERT / VAGINAL		RLD, RS	2016-11-16

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N208470-001	8629129	2028-08-07		Drug product	2016-12-08
N208470-001	8957054	2030-01-08	U-1922		2016-12-08
N208470-001	8268806	2031-03-19		Drug product	2016-12-08

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N208470-001	INTRAROSA	6.5MG	INSERT / VAGINAL	RLD, RS	2016-11-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208470-001	INTRAROSA	6.5MG	INSERT / VAGINAL	RLD, RS	2016-11-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208470-001	INTRAROSA	6.5MG	INSERT / VAGINAL	RLD, RS	2016-11-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208470-001	INTRAROSA	6.5MG	INSERT / VAGINAL	RLD, RS	2016-11-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208470-001	INTRAROSA	6.5MG	INSERT / VAGINAL	RLD, RS	2016-11-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208470-001	INTRAROSA	6.5MG	INSERT / VAGINAL	RLD, RS	2016-11-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208470-001	INTRAROSA	6.5MG	INSERT / VAGINAL	RLD, RS	2016-11-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208470-001	INTRAROSA	6.5MG	INSERT / VAGINAL	RLD, RS	2016-11-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208470-001	INTRAROSA	6.5MG	INSERT / VAGINAL	RLD, RS	2016-11-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208470-001	INTRAROSA	6.5MG	INSERT / VAGINAL	RLD, RS	2016-11-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208470-001	INTRAROSA	6.5MG	INSERT / VAGINAL	RLD, RS	2016-11-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208470-001	INTRAROSA	6.5MG	INSERT / VAGINAL	RLD, RS	2016-11-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208470-001	INTRAROSA	6.5MG	INSERT / VAGINAL	RLD, RS	2016-11-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208470-001	INTRAROSA	6.5MG	INSERT / VAGINAL	RLD, RS	2016-11-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208470-001	INTRAROSA	6.5MG	INSERT / VAGINAL	RLD, RS	2016-11-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208470-001	INTRAROSA	6.5MG	INSERT / VAGINAL	RLD, RS	2016-11-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208470-001	INTRAROSA	6.5MG	INSERT / VAGINAL	RLD, RS	2016-11-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208470-001	INTRAROSA	6.5MG	INSERT / VAGINAL	RLD, RS	2016-11-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208470-001	INTRAROSA	6.5MG	INSERT / VAGINAL	RLD, RS	2016-11-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208470-001	INTRAROSA	6.5MG	INSERT / VAGINAL	RLD, RS	2016-11-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208470-001	INTRAROSA	6.5MG	INSERT / VAGINAL	RLD, RS	2016-11-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208470-001	INTRAROSA	6.5MG	INSERT / VAGINAL	RLD, RS	2016-11-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208470-001	INTRAROSA	6.5MG	INSERT / VAGINAL	RLD, RS	2016-11-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208470-001	INTRAROSA	6.5MG	INSERT / VAGINAL	RLD, RS	2016-11-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208470-001	INTRAROSA	6.5MG	INSERT / VAGINAL	RLD, RS	2016-11-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208470-001	INTRAROSA	6.5MG	INSERT / VAGINAL	RLD, RS	2016-11-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208470-001	INTRAROSA	6.5MG	INSERT / VAGINAL	RLD, RS	2016-11-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208470-001	INTRAROSA	6.5MG	INSERT / VAGINAL	RLD, RS	2016-11-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208470-001	INTRAROSA	6.5MG	INSERT / VAGINAL	RLD, RS	2016-11-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208470-001	INTRAROSA	6.5MG	INSERT / VAGINAL	RLD, RS	2016-11-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N208470-001	INTRAROSA	6.5MG	INSERT / VAGINAL	RLD, RS	2016-11-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208470-001	INTRAROSA	6.5MG	INSERT / VAGINAL	RLD, RS	2016-11-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208470-001	INTRAROSA	6.5MG	INSERT / VAGINAL	RLD, RS	2016-11-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208470-001	INTRAROSA	6.5MG	INSERT / VAGINAL	RLD, RS	2016-11-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208470-001	INTRAROSA	6.5MG	INSERT / VAGINAL	RLD, RS	2016-11-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208470-001	INTRAROSA	6.5MG	INSERT / VAGINAL	RLD, RS	2016-11-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N208470-001	INTRAROSA	6.5MG	INSERT / VAGINAL	RLD, RS	2016-11-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208470-001	INTRAROSA	6.5MG	INSERT / VAGINAL	RLD, RS	2016-11-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208470-001	INTRAROSA	6.5MG	INSERT / VAGINAL	RLD, RS	2016-11-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N208470-001	INTRAROSA	6.5MG	INSERT / VAGINAL	RLD, RS	2016-11-16	`e64feba35796…`

Observed Orange Book patent history#

Patent history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N208470-001	8629129	2028-08-07		Drug product	2016-12-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208470-001	8957054	2030-01-08	U-1922		2016-12-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208470-001	8268806	2031-03-19		Drug product	2016-12-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208470-001	8629129	2028-08-07		Drug product	2016-12-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208470-001	8957054	2030-01-08	U-1922		2016-12-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208470-001	8268806	2031-03-19		Drug product	2016-12-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208470-001	8629129	2028-08-07		Drug product	2016-12-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208470-001	8957054	2030-01-08	U-1922		2016-12-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208470-001	8268806	2031-03-19		Drug product	2016-12-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208470-001	8629129	2028-08-07		Drug product	2016-12-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208470-001	8957054	2030-01-08	U-1922		2016-12-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208470-001	8268806	2031-03-19		Drug product	2016-12-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208470-001	8629129	2028-08-07		Drug product	2016-12-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208470-001	8957054	2030-01-08	U-1922		2016-12-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208470-001	8268806	2031-03-19		Drug product	2016-12-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208470-001	8629129	2028-08-07		Drug product	2016-12-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208470-001	8957054	2030-01-08	U-1922		2016-12-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208470-001	8268806	2031-03-19		Drug product	2016-12-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208470-001	8629129	2028-08-07		Drug product	2016-12-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208470-001	8957054	2030-01-08	U-1922		2016-12-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208470-001	8268806	2031-03-19		Drug product	2016-12-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208470-001	8629129	2028-08-07		Drug product	2016-12-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208470-001	8957054	2030-01-08	U-1922		2016-12-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208470-001	8268806	2031-03-19		Drug product	2016-12-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208470-001	8629129	2028-08-07		Drug product	2016-12-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208470-001	8957054	2030-01-08	U-1922		2016-12-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208470-001	8268806	2031-03-19		Drug product	2016-12-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208470-001	8629129	2028-08-07		Drug product	2016-12-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208470-001	8957054	2030-01-08	U-1922		2016-12-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208470-001	8268806	2031-03-19		Drug product	2016-12-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208470-001	8629129	2028-08-07		Drug product	2016-12-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N208470-001	8957054	2030-01-08	U-1922		2016-12-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N208470-001	8268806	2031-03-19		Drug product	2016-12-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208470-001	8629129	2028-08-07		Drug product	2016-12-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208470-001	8957054	2030-01-08	U-1922		2016-12-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208470-001	8268806	2031-03-19		Drug product	2016-12-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208470-001	8629129	2028-08-07		Drug product	2016-12-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208470-001	8957054	2030-01-08	U-1922		2016-12-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208470-001	8268806	2031-03-19		Drug product	2016-12-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208470-001	8629129	2028-08-07		Drug product	2016-12-08	`1e350fbaab3a…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N208470-001	NCE	2021-11-16	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N208470-001	NCE	2021-11-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208470-001	NCE	2021-11-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208470-001	NCE	2021-11-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208470-001	NCE	2021-11-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208470-001	NCE	2021-11-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208470-001	NCE	2021-11-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208470-001	NCE	2021-11-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208470-001	NCE	2021-11-16	`ea99ee380514…`

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
Intrarosa	PRASTERONE	Millicent US, Inc.	ada639d4-bac0-2ad0-e053-2a95a90afce7	2026-07-17	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208470 application number: NDA208470 ndc (product): 72495-501 ndc (product): 72495-401

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
64011-601	Intrarosa	Prasterone	AMAG Pharmaceuticals, Inc.	NDA	Current
64011-601	Intrarosa	Prasterone	AMAG Pharmaceuticals, Inc.	NDA	Current
64011-601	Intrarosa	Prasterone	AMAG Pharmaceuticals, Inc.	NDA	Current
64011-601	Intrarosa	Prasterone	AMAG Pharmaceuticals, Inc.	NDA	Current
64011-601	Intrarosa	Prasterone	AMAG Pharmaceuticals, Inc.	NDA	Current
72495-401	Intrarosa	Prasterone	Millicent US, Inc.	NDA	Current
72495-401	Intrarosa	Prasterone	Millicent US, Inc.	NDA	Current
72495-401	Intrarosa	Prasterone	Millicent US, Inc.	NDA	Current
72495-501	Intrarosa	Prasterone	Millicent US, Inc.	NDA	Current
72495-501	Intrarosa	Prasterone	Millicent US, Inc.	NDA	Current
72495-501	Intrarosa	Prasterone	Millicent US, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
52624	SUPPL	2018-02-14
51046	ORIG	2018-01-12
45905	ORIG	2016-11-17
45902	ORIG	2016-11-16