Application 017439

Type: NDA
Sponsor: ALLERGAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HYDROXYPROGESTERONE CAPROATE	HYDROXYPROGESTERONE CAPROATE	INJECTABLE;INJECTION	125MG/ML	No	No
002	HYDROXYPROGESTERONE CAPROATE	HYDROXYPROGESTERONE CAPROATE	INJECTABLE;INJECTION	250MG/ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N017439-001	HYDROXYPROGESTERONE CAPROATE	HYDROXYPROGESTERONE CAPROATE	125MG/ML	INJECTABLE / INJECTION		Approved before 1982
N017439-002	HYDROXYPROGESTERONE CAPROATE	HYDROXYPROGESTERONE CAPROATE	250MG/ML	INJECTABLE / INJECTION		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 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N017439-001	HYDROXYPROGESTERONE CAPROATE	125MG/ML	INJECTABLE / INJECTION	Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N017439-002	HYDROXYPROGESTERONE CAPROATE	250MG/ML	INJECTABLE / INJECTION	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N017439-001	HYDROXYPROGESTERONE CAPROATE	125MG/ML	INJECTABLE / INJECTION	Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N017439-002	HYDROXYPROGESTERONE CAPROATE	250MG/ML	INJECTABLE / INJECTION	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N017439-001	HYDROXYPROGESTERONE CAPROATE	125MG/ML	INJECTABLE / INJECTION	Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N017439-002	HYDROXYPROGESTERONE CAPROATE	250MG/ML	INJECTABLE / INJECTION	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017439-001	HYDROXYPROGESTERONE CAPROATE	125MG/ML	INJECTABLE / INJECTION	Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017439-002	HYDROXYPROGESTERONE CAPROATE	250MG/ML	INJECTABLE / INJECTION	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N017439-001	HYDROXYPROGESTERONE CAPROATE	125MG/ML	INJECTABLE / INJECTION	Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N017439-002	HYDROXYPROGESTERONE CAPROATE	250MG/ML	INJECTABLE / INJECTION	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N017439-001	HYDROXYPROGESTERONE CAPROATE	125MG/ML	INJECTABLE / INJECTION	Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N017439-002	HYDROXYPROGESTERONE CAPROATE	250MG/ML	INJECTABLE / INJECTION	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N017439-001	HYDROXYPROGESTERONE CAPROATE	125MG/ML	INJECTABLE / INJECTION	Approved before 1982	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N017439-002	HYDROXYPROGESTERONE CAPROATE	250MG/ML	INJECTABLE / INJECTION	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N017439-001	HYDROXYPROGESTERONE CAPROATE	125MG/ML	INJECTABLE / INJECTION	Approved before 1982	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N017439-002	HYDROXYPROGESTERONE CAPROATE	250MG/ML	INJECTABLE / INJECTION	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N017439-001	HYDROXYPROGESTERONE CAPROATE	125MG/ML	INJECTABLE / INJECTION	Approved before 1982	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N017439-002	HYDROXYPROGESTERONE CAPROATE	250MG/ML	INJECTABLE / INJECTION	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N017439-001	HYDROXYPROGESTERONE CAPROATE	125MG/ML	INJECTABLE / INJECTION	Approved before 1982	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N017439-002	HYDROXYPROGESTERONE CAPROATE	250MG/ML	INJECTABLE / INJECTION	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017439-001	HYDROXYPROGESTERONE CAPROATE	125MG/ML	INJECTABLE / INJECTION	Approved before 1982	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017439-002	HYDROXYPROGESTERONE CAPROATE	250MG/ML	INJECTABLE / INJECTION	Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N017439-001	HYDROXYPROGESTERONE CAPROATE	125MG/ML	INJECTABLE / INJECTION	Approved before 1982	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N017439-002	HYDROXYPROGESTERONE CAPROATE	250MG/ML	INJECTABLE / INJECTION	Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N017439-001	HYDROXYPROGESTERONE CAPROATE	125MG/ML	INJECTABLE / INJECTION	Approved before 1982	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N017439-002	HYDROXYPROGESTERONE CAPROATE	250MG/ML	INJECTABLE / INJECTION	Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017439-001	HYDROXYPROGESTERONE CAPROATE	125MG/ML	INJECTABLE / INJECTION	Approved before 1982	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017439-002	HYDROXYPROGESTERONE CAPROATE	250MG/ML	INJECTABLE / INJECTION	Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017439-001	HYDROXYPROGESTERONE CAPROATE	125MG/ML	INJECTABLE / INJECTION	Approved before 1982	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017439-002	HYDROXYPROGESTERONE CAPROATE	250MG/ML	INJECTABLE / INJECTION	Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017439-001	HYDROXYPROGESTERONE CAPROATE	125MG/ML	INJECTABLE / INJECTION	Approved before 1982	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017439-002	HYDROXYPROGESTERONE CAPROATE	250MG/ML	INJECTABLE / INJECTION	Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017439-001	HYDROXYPROGESTERONE CAPROATE	125MG/ML	INJECTABLE / INJECTION	Approved before 1982	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017439-002	HYDROXYPROGESTERONE CAPROATE	250MG/ML	INJECTABLE / INJECTION	Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N017439-001	HYDROXYPROGESTERONE CAPROATE	125MG/ML	INJECTABLE / INJECTION	Approved before 1982	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N017439-002	HYDROXYPROGESTERONE CAPROATE	250MG/ML	INJECTABLE / INJECTION	Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N017439-001	HYDROXYPROGESTERONE CAPROATE	125MG/ML	INJECTABLE / INJECTION	Approved before 1982	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N017439-002	HYDROXYPROGESTERONE CAPROATE	250MG/ML	INJECTABLE / INJECTION	Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017439-001	HYDROXYPROGESTERONE CAPROATE	125MG/ML	INJECTABLE / INJECTION	Approved before 1982	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017439-002	HYDROXYPROGESTERONE CAPROATE	250MG/ML	INJECTABLE / INJECTION	Approved before 1982	`3a93d1ddd44b…`

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
Hydroxyprogesterone Caproate	HYDROXYPROGESTERONE CAPROATE	Eugia US LLC	687bcf42-f437-42c7-8909-a91f621f55df	2026-06-12	Warnings, Adverse reactions	Name fallback brand name: Hydroxyprogesterone Caproate generic name: HYDROXYPROGESTERONE CAPROATE

Reported adverse events (FAERS/openFDA)#

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