Application 017362

Type: NDA
Sponsor: ACTAVIS LABS UT INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	PROGESTERONE	PROGESTERONE	INJECTABLE;INJECTION	50MG/ML	Yes	Yes

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
N017362-002	PROGESTERONE	PROGESTERONE	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-09-14 22:38:34	2026-08	N017362-002	PROGESTERONE	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N017362-002	PROGESTERONE	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N017362-002	PROGESTERONE	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017362-002	PROGESTERONE	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017362-002	PROGESTERONE	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017362-002	PROGESTERONE	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017362-002	PROGESTERONE	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017362-002	PROGESTERONE	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017362-002	PROGESTERONE	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017362-002	PROGESTERONE	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017362-002	PROGESTERONE	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017362-002	PROGESTERONE	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017362-002	PROGESTERONE	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017362-002	PROGESTERONE	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017362-002	PROGESTERONE	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017362-002	PROGESTERONE	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017362-002	PROGESTERONE	50MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N017362-002	PROGESTERONE	50MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N017362-002	PROGESTERONE	50MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N017362-002	PROGESTERONE	50MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N017362-002	PROGESTERONE	50MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N017362-002	PROGESTERONE	50MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017362-002	PROGESTERONE	50MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N017362-002	PROGESTERONE	50MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N017362-002	PROGESTERONE	50MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N017362-002	PROGESTERONE	50MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N017362-002	PROGESTERONE	50MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N017362-002	PROGESTERONE	50MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N017362-002	PROGESTERONE	50MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017362-002	PROGESTERONE	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N017362-002	PROGESTERONE	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N017362-002	PROGESTERONE	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017362-002	PROGESTERONE	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017362-002	PROGESTERONE	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017362-002	PROGESTERONE	50MG/ML	INJECTABLE / INJECTION		RLD, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017362-002	PROGESTERONE	50MG/ML	INJECTABLE / INJECTION		RLD, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N017362-002	PROGESTERONE	50MG/ML	INJECTABLE / INJECTION		RLD, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N017362-002	PROGESTERONE	50MG/ML	INJECTABLE / INJECTION		RLD, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017362-002	PROGESTERONE	50MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N017362-002	PROGESTERONE	50MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017362-002	AO	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N017362-002	AO	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N017362-002	AO	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N017362-002	AO	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N017362-002	AO	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N017362-002	AO	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017362-002	AO	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N017362-002	AO	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N017362-002	AO	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N017362-002	AO	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N017362-002	AO	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N017362-002	AO	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N017362-002	AO	1	`ea99ee380514…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017362-002	AO	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N017362-002	AO	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N017362-002	AO	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N017362-002	AO	1	`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 4 · 69 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PROGESTERONE	PROGESTERONE	REMEDYREPACK INC.	947ebb7c-492b-4b83-aa1c-81e282df6421	2026-08-28	Warnings, Adverse reactions	Name fallback brand name: PROGESTERONE generic name: PROGESTERONE
PROGESTERONE	PROGESTERONE	Preferred Pharmaceuticals Inc.	404e0b45-339b-4304-8e33-5f4ffe8f8e25	2026-08-24	Warnings, Adverse reactions	Name fallback brand name: PROGESTERONE generic name: PROGESTERONE
ENDOMETRIN	PROGESTERONE	Ferring Pharmaceuticals Inc.	2ba50fa9-b349-40cb-9a4b-1af8faa4ec09	2026-07-29	Warnings, Adverse reactions	Name fallback generic name: PROGESTERONE
Progesterone	PROGESTERONE	REMEDYREPACK INC.	f7615864-be6e-47b4-bf35-145a361d7cc6	2026-07-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Progesterone generic name: PROGESTERONE
Prometrium	PROGESTERONE	Acertis Pharmaceuticals, LLC	1cf237ff-c4f8-4faa-a7aa-77599c856889	2026-07-23	Warnings, Adverse reactions	Name fallback generic name: PROGESTERONE
Progesterone	PROGESTERONE	Redpharm Drug	5743b2e4-093f-c59a-e063-6394a90aae2b	2026-07-23	Warnings, Adverse reactions	Name fallback brand name: Progesterone generic name: PROGESTERONE
Progesterone	PROGESTERONE	NorthStar Rx LLC	f392c6d9-1420-4735-aa01-f434da9b31b3	2026-06-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Progesterone generic name: PROGESTERONE
Progesterone	PROGESTERONE	A-S Medication Solutions	bc62ae6d-b609-432d-863f-a8ecd223d69a	2026-06-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Progesterone generic name: PROGESTERONE
PROGESTERONE	PROGESTERONE	Golden State Medical Supply, Inc.	312db3af-9dd2-d5e4-e063-6394a90af999	2026-06-18	Warnings, Adverse reactions	Name fallback brand name: PROGESTERONE generic name: PROGESTERONE
Progesterone	PROGESTERONE	AvKARE	42c84fec-e5eb-78f7-e063-6294a90a4c0e	2026-06-16	Warnings, Adverse reactions	Name fallback brand name: Progesterone generic name: PROGESTERONE
Progesterone	PROGESTERONE	Bryant Ranch Prepack	1ba10f9d-6e91-4954-ac91-23adcf8805b0	2026-06-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Progesterone generic name: PROGESTERONE
Progesterone	PROGESTERONE	Bryant Ranch Prepack	74a7619a-8f74-4889-96f6-5bae478543e8	2026-06-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Progesterone generic name: PROGESTERONE
PROGESTERONE	PROGESTERONE	Bionpharma Inc.	41b3c3a7-5fb8-4451-a96c-2bd02613c021	2026-05-29	Warnings, Adverse reactions	Name fallback brand name: PROGESTERONE generic name: PROGESTERONE
PROGESTERONE	PROGESTERONE	Sun Pharmaceutical Industries, Inc.	fcdde0d0-4329-4725-a76b-684f9d97fe95	2026-05-19	Warnings, Adverse reactions	Name fallback brand name: PROGESTERONE generic name: PROGESTERONE
Progesterone	PROGESTERONE	AvKARE	1637ac18-3a37-f3d5-e063-6394a90af157	2026-05-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Progesterone generic name: PROGESTERONE
PROGESTERONE	PROGESTERONE	A-S Medication Solutions	566584fc-c76a-4e42-a62e-109a2903b939	2026-05-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: PROGESTERONE generic name: PROGESTERONE
Natural Progesterone	PROGESTERONE	BioActive Nutritional, Inc.	772629aa-af5e-4493-aaf2-3c75bfd7d8c2	2026-05-05	Warnings	Name fallback generic name: PROGESTERONE
Progesterone	PROGESTERONE	Hikma Pharmaceuticals USA Inc	d8bcc439-c21d-4eeb-9159-f51e0c60bd70	2026-04-28	Warnings, Adverse reactions	Name fallback brand name: Progesterone generic name: PROGESTERONE
PROGESTERONE VAGINAL INSERTS	PROGESTERONE	Glenmark Pharmaceuticals Inc., USA	41682665-e889-4e2a-9382-88f6bcc30237	2026-04-17	Warnings, Adverse reactions	Name fallback generic name: PROGESTERONE
Progesterone	PROGESTERONE	BioActive Nutritional, Inc.	cddb5afa-9825-418d-acf6-cffbb0fc39c3	2026-03-10	Warnings	Name fallback brand name: Progesterone 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 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0591-3128	PROGESTERONE	PROGESTERONE	Actavis Pharma, Inc.	NDA	Current
0591-3128	PROGESTERONE	PROGESTERONE	Actavis Pharma, Inc.	NDA	Current
0591-3128	PROGESTERONE	PROGESTERONE	Actavis Pharma, Inc.	NDA	Current
0591-3128	PROGESTERONE	PROGESTERONE	Actavis Pharma, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
55323	SUPPL	2018-08-27
55298	SUPPL	2018-08-24
33242	SUPPL	2007-01-16
564	SUPPL	2007-01-16