Application 201110

Type: NDA
Sponsor: Ferring Pharmaceuticals, Inc.

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MILPROSA	PROGESTERONE	RING;VAGINAL	1.78g	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
N201110-001	MILPROSA	PROGESTERONE	1.78GM	SYSTEM / VAGINAL		RLD	2020-04-29

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
N201110-001	10537584	2029-02-03		Drug product	2020-05-19
N201110-001	10548904	2029-02-03	U-2810		2020-05-19
N201110-001	8580293	2030-01-21	U-2810		2020-05-19

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	N201110-001	MILPROSA	1.78GM	SYSTEM / VAGINAL	RLD	2020-04-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N201110-001	MILPROSA	1.78GM	SYSTEM / VAGINAL	RLD	2020-04-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N201110-001	MILPROSA	1.78GM	SYSTEM / VAGINAL	RLD	2020-04-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201110-001	MILPROSA	1.78GM	SYSTEM / VAGINAL	RLD	2020-04-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N201110-001	MILPROSA	1.78GM	SYSTEM / VAGINAL	RLD	2020-04-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201110-001	MILPROSA	1.78GM	SYSTEM / VAGINAL	RLD	2020-04-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201110-001	MILPROSA	1.78GM	SYSTEM / VAGINAL	RLD	2020-04-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201110-001	MILPROSA	1.78GM	SYSTEM / VAGINAL	RLD	2020-04-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201110-001	MILPROSA	1.78GM	SYSTEM / VAGINAL	RLD	2020-04-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N201110-001	MILPROSA	1.78GM	SYSTEM / VAGINAL	RLD	2020-04-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N201110-001	MILPROSA	1.78GM	SYSTEM / VAGINAL	RLD	2020-04-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N201110-001	MILPROSA	1.78GM	SYSTEM / VAGINAL	RLD	2020-04-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N201110-001	MILPROSA	1.78GM	SYSTEM / VAGINAL	RLD	2020-04-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N201110-001	MILPROSA	1.78GM	SYSTEM / VAGINAL	RLD	2020-04-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N201110-001	MILPROSA	1.78GM	SYSTEM / VAGINAL	RLD	2020-04-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N201110-001	MILPROSA	1.78GM	SYSTEM / VAGINAL	RLD	2020-04-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N201110-001	MILPROSA	1.78GM	SYSTEM / VAGINAL	RLD	2020-04-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N201110-001	MILPROSA	1.78GM	SYSTEM / VAGINAL	RLD	2020-04-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N201110-001	MILPROSA	1.78GM	SYSTEM / VAGINAL	RLD	2020-04-29	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N201110-001	MILPROSA	1.78GM	SYSTEM / VAGINAL	RLD	2020-04-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N201110-001	MILPROSA	1.78GM	SYSTEM / VAGINAL	RLD	2020-04-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N201110-001	MILPROSA	1.78GM	SYSTEM / VAGINAL	RLD	2020-04-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N201110-001	MILPROSA	1.78GM	SYSTEM / VAGINAL	RLD	2020-04-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N201110-001	MILPROSA	1.78GM	SYSTEM / VAGINAL	RLD	2020-04-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N201110-001	MILPROSA	1.78GM	SYSTEM / VAGINAL	RLD	2020-04-29	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N201110-001	MILPROSA	1.78GM	SYSTEM / VAGINAL	RLD	2020-04-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N201110-001	MILPROSA	1.78GM	SYSTEM / VAGINAL	RLD	2020-04-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N201110-001	MILPROSA	1.78GM	SYSTEM / VAGINAL	RLD	2020-04-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N201110-001	MILPROSA	1.78GM	SYSTEM / VAGINAL	RLD	2020-04-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N201110-001	MILPROSA	1.78GM	SYSTEM / VAGINAL	RLD	2020-04-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N201110-001	MILPROSA	1.78GM	SYSTEM / VAGINAL	RLD	2020-04-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N201110-001	MILPROSA	1.78GM	SYSTEM / VAGINAL	RLD	2020-04-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N201110-001	MILPROSA	1.78GM	SYSTEM / VAGINAL	RLD	2020-04-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N201110-001	MILPROSA	1.78GM	SYSTEM / VAGINAL	RLD	2020-04-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N201110-001	MILPROSA	1.78GM	SYSTEM / VAGINAL	RLD	2020-04-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N201110-001	MILPROSA	1.78GM	SYSTEM / VAGINAL	RLD	2020-04-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N201110-001	MILPROSA	1.78GM	SYSTEM / VAGINAL	RLD	2020-04-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N201110-001	MILPROSA	1.78GM	SYSTEM / VAGINAL	RLD	2020-04-29	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N201110-001	MILPROSA	1.78GM	SYSTEM / VAGINAL	RLD	2020-04-29	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 117 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	N201110-001	10537584	2029-02-03		Drug product	2020-05-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201110-001	10548904	2029-02-03	U-2810		2020-05-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201110-001	8580293	2030-01-21	U-2810		2020-05-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N201110-001	10537584	2029-02-03		Drug product	2020-05-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201110-001	10548904	2029-02-03	U-2810		2020-05-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201110-001	8580293	2030-01-21	U-2810		2020-05-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N201110-001	10537584	2029-02-03		Drug product	2020-05-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201110-001	10548904	2029-02-03	U-2810		2020-05-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201110-001	8580293	2030-01-21	U-2810		2020-05-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201110-001	10537584	2029-02-03		Drug product	2020-05-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201110-001	10548904	2029-02-03	U-2810		2020-05-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201110-001	8580293	2030-01-21	U-2810		2020-05-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N201110-001	10537584	2029-02-03		Drug product	2020-05-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201110-001	10548904	2029-02-03	U-2810		2020-05-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201110-001	8580293	2030-01-21	U-2810		2020-05-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201110-001	10537584	2029-02-03		Drug product	2020-05-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201110-001	10548904	2029-02-03	U-2810		2020-05-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201110-001	8580293	2030-01-21	U-2810		2020-05-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201110-001	10537584	2029-02-03		Drug product	2020-05-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201110-001	10548904	2029-02-03	U-2810		2020-05-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201110-001	8580293	2030-01-21	U-2810		2020-05-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201110-001	10537584	2029-02-03		Drug product	2020-05-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201110-001	10548904	2029-02-03	U-2810		2020-05-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201110-001	8580293	2030-01-21	U-2810		2020-05-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201110-001	10537584	2029-02-03		Drug product	2020-05-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201110-001	10548904	2029-02-03	U-2810		2020-05-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201110-001	8580293	2030-01-21	U-2810		2020-05-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N201110-001	10537584	2029-02-03		Drug product	2020-05-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N201110-001	10548904	2029-02-03	U-2810		2020-05-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N201110-001	8580293	2030-01-21	U-2810		2020-05-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N201110-001	10537584	2029-02-03		Drug product	2020-05-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N201110-001	10548904	2029-02-03	U-2810		2020-05-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N201110-001	8580293	2030-01-21	U-2810		2020-05-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N201110-001	10537584	2029-02-03		Drug product	2020-05-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N201110-001	10548904	2029-02-03	U-2810		2020-05-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N201110-001	8580293	2030-01-21	U-2810		2020-05-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N201110-001	10537584	2029-02-03		Drug product	2020-05-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N201110-001	10548904	2029-02-03	U-2810		2020-05-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N201110-001	8580293	2030-01-21	U-2810		2020-05-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N201110-001	10537584	2029-02-03		Drug product	2020-05-19	`301d65b070ca…`

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	N201110-001	NP	2023-04-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N201110-001	NP	2023-04-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N201110-001	NP	2023-04-29	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N201110-001	NP	2023-04-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N201110-001	NP	2023-04-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N201110-001	NP	2023-04-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N201110-001	NP	2023-04-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N201110-001	NP	2023-04-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N201110-001	NP	2023-04-29	`c0c555d07b60…`
2023-12-20 04:57 UTC	2023-12	N201110-001	NP	2023-04-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N201110-001	NP	2023-04-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N201110-001	NP	2023-04-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N201110-001	NP	2023-04-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N201110-001	NP	2023-04-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N201110-001	NP	2023-04-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N201110-001	NP	2023-04-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N201110-001	NP	2023-04-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N201110-001	NP	2023-04-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N201110-001	NP	2023-04-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N201110-001	NP	2023-04-29	`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 4 of 4 · 69 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Progesterone	PROGESTERONE	Asclemed USA, Inc.	fd6b9861-04fc-42d8-90c8-021a69fe93e9	2023-07-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROGESTERONE
Progesterone	PROGESTERONE	A-S Medication Solutions	5e0263c5-2cb6-4e02-b883-2c05492a6260	2023-05-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROGESTERONE
Progesterone Combo	PROGESTERONE	Nutritional Specialties, Inc.	5ccf7bee-2da4-4347-8753-30680d7c1c03	2023-04-27	Warnings	Name fallback generic name: PROGESTERONE
Progesterone	PROGESTERONE	Asclemed USA, Inc.	19716042-8025-43a3-b26d-e0fd7d2587eb	2022-10-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROGESTERONE
Progesterone	PROGESTERONE	Asclemed USA, Inc.	efd6a8d8-c023-4d9f-b574-b14dc945203d	2022-10-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROGESTERONE
Progesterone	PROGESTERONE	Asclemed USA, Inc.	4a741977-1dbb-41e7-a560-9ac02936f8b1	2022-09-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROGESTERONE
Progesterone	PROGESTERONE	Proficient Rx LP	e1546b35-cfa8-4808-9652-db1ba675a4e3	2022-08-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROGESTERONE
Progesterone	PROGESTERONE	Proficient Rx LP	73e65b35-2266-48a3-98f8-521446a55c22	2022-04-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROGESTERONE
PROGESTERONE	PROGESTERONE	Bionpharma Inc.	3acad9b0-7ec6-4d5e-9852-32ffadbbed6d	2018-03-11	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROGESTERONE

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
55566-9400	Ferring Pharmaceuticals Inc.	progesterone	Ferring Pharmaceuticals Inc.	NDA	Current
55566-9400	Ferring Pharmaceuticals Inc.	progesterone	Ferring Pharmaceuticals Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
63937	ORIG	2020-07-16
62775	ORIG	2020-04-30
62771	ORIG	2020-04-30