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N017362-002	PROGESTERONE	PROGESTERONE	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982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N017362-002	PROGESTERONE	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`84e616aacf4f…`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N017362-002	PROGESTERONE	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`caaa826d4ba7…`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UTC	2026-02	N017362-002	PROGESTERONE	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`011fe1cb6892…`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this ZIP	2025-12	N017362-002	PROGESTERONE	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`31067a03dcf5…`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 3 of 4 · 69 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PROGESTERONE	PROGESTERONE	Bryant Ranch Prepack	0aeb0f0f-2749-416b-942f-83950200fd75	2025-05-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: PROGESTERONE generic name: PROGESTERONE
PROGESTERONE	PROGESTERONE	Asclemed USA, Inc.	342a096d-df6f-47de-bdd1-ec259638e476	2025-05-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: PROGESTERONE generic name: PROGESTERONE
PROGESTERONE	PROGESTERONE	XIROMED, LLC	dcfa4050-d142-b774-369f-8a421eb23c62	2025-03-06	Warnings, Adverse reactions	Name fallback brand name: PROGESTERONE generic name: PROGESTERONE
Progesterone	PROGESTERONE	Newton Laboratories, Inc.	9e038e0b-a124-1870-e053-2995a90a49f8	2025-02-10	Warnings	Name fallback brand name: Progesterone generic name: PROGESTERONE
PROGESTERONE	PROGESTERONE	Direct Rx	dc9e2088-e11e-7d32-e053-2a95a90a2995	2025-01-22	Warnings	Name fallback brand name: PROGESTERONE generic name: PROGESTERONE
PROGESTERONE	PROGESTERONE	direct rx	c33e6c10-3149-57c3-e053-2995a90a3fa1	2025-01-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: PROGESTERONE generic name: PROGESTERONE
Progesterone Phenolic	PROGESTERONE	Energique, Inc.	177c7d38-d133-4e3b-a81e-f6bacd39b147	2024-10-29	Warnings	Name fallback generic name: PROGESTERONE
Progesterone	PROGESTERONE	Fresenius Kabi USA, LLC	a479b395-1e1a-4d2a-8feb-68a15c47225f	2024-10-15	Warnings, Adverse reactions	Name fallback brand name: Progesterone generic name: PROGESTERONE
Progesterone	PROGESTERONE	Bryant Ranch Prepack	1220b231-4765-4879-acb8-d7887d863a28	2024-07-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Progesterone generic name: PROGESTERONE
PROGESTERONE	PROGESTERONE	NuCare Pharmaceuticals,Inc.	0d976866-81b3-5db8-e063-6294a90a39f9	2024-07-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: PROGESTERONE generic name: PROGESTERONE
Progesterone	PROGESTERONE	Hikma Pharmaceuticals USA Inc.	83cfc12e-75d1-4284-bcc3-beadcbd27171	2024-07-09	Warnings, Adverse reactions	Name fallback brand name: Progesterone generic name: PROGESTERONE
Progesterone	PROGESTERONE	Proficient Rx LP	80a63b2b-96be-423d-abbd-13acc802f6da	2024-06-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Progesterone generic name: PROGESTERONE
Crinone	PROGESTERONE	Allergan, Inc.	75e97aa1-daa4-45f9-b2e2-1a371302914e	2024-05-21	Warnings, Adverse reactions	Name fallback generic name: PROGESTERONE
Progesterone	PROGESTERONE	Bryant Ranch Prepack	1c71a4b0-1347-498f-8124-f4cb4be27b61	2024-05-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Progesterone generic name: PROGESTERONE
Progesterone	PROGESTERONE	Bryant Ranch Prepack	b74caa23-a5b8-42dd-ab48-4b7a2f015deb	2024-05-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Progesterone generic name: PROGESTERONE
Progesterone	PROGESTERONE	Deseret Biologicals, Inc.	ef33af80-5f72-4635-a8ae-f48376efb451	2024-03-14	Warnings	Name fallback brand name: Progesterone generic name: PROGESTERONE
Progesterone	PROGESTERONE	Dr. Reddys Laboratories, Inc.	efded380-02ff-68c9-13e4-47a561ede440	2024-03-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Progesterone generic name: PROGESTERONE
Progesterone	PROGESTERONE	Aurobindo Pharma Limited	7d73f08d-2de7-44b6-9e44-2d488fe02517	2024-03-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Progesterone generic name: PROGESTERONE
Progesterone	PROGESTERONE	A-S Medication Solutions	96c59a1c-d562-46dd-868b-b2decdfef319	2023-11-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Progesterone generic name: PROGESTERONE
Progesterone	PROGESTERONE	Eugia US LLC	7d19df3b-94ed-4681-beae-9caaf137d014	2023-09-12	Warnings, Adverse reactions	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