Application 211777

Type: ANDA
Sponsor: ASPEN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HYDROXYPROGESTERONE CAPROATE	HYDROXYPROGESTERONE CAPROATE	SOLUTION;INTRAMUSCULAR	250MG/ML (250MG/ML)	No	No

Source provenance: Browse the complete Orange Book source catalog.

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	Product TE source text	Approval date	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211777-001	HYDROXYPROGESTERONE CAPROATE	250MG/ML (250MG/ML)	SOLUTION / INTRAMUSCULAR	AP	2019-08-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211777-001	HYDROXYPROGESTERONE CAPROATE	250MG/ML (250MG/ML)	SOLUTION / INTRAMUSCULAR	AP	2019-08-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211777-001	HYDROXYPROGESTERONE CAPROATE	250MG/ML (250MG/ML)	SOLUTION / INTRAMUSCULAR	AP	2019-08-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211777-001	HYDROXYPROGESTERONE CAPROATE	250MG/ML (250MG/ML)	SOLUTION / INTRAMUSCULAR	AP	2019-08-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211777-001	HYDROXYPROGESTERONE CAPROATE	250MG/ML (250MG/ML)	SOLUTION / INTRAMUSCULAR	AP	2019-08-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211777-001	HYDROXYPROGESTERONE CAPROATE	250MG/ML (250MG/ML)	SOLUTION / INTRAMUSCULAR	AP	2019-08-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211777-001	HYDROXYPROGESTERONE CAPROATE	250MG/ML (250MG/ML)	SOLUTION / INTRAMUSCULAR	AP	2019-08-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211777-001	HYDROXYPROGESTERONE CAPROATE	250MG/ML (250MG/ML)	SOLUTION / INTRAMUSCULAR	AP	2019-08-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211777-001	HYDROXYPROGESTERONE CAPROATE	250MG/ML (250MG/ML)	SOLUTION / INTRAMUSCULAR	AP	2019-08-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211777-001	HYDROXYPROGESTERONE CAPROATE	250MG/ML (250MG/ML)	SOLUTION / INTRAMUSCULAR	AP	2019-08-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211777-001	HYDROXYPROGESTERONE CAPROATE	250MG/ML (250MG/ML)	SOLUTION / INTRAMUSCULAR	AP	2019-08-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211777-001	HYDROXYPROGESTERONE CAPROATE	250MG/ML (250MG/ML)	SOLUTION / INTRAMUSCULAR	AP	2019-08-08	`b00525d2431f…`
2023-01-26 05:58 UTC	2023-01	A211777-001	HYDROXYPROGESTERONE CAPROATE	250MG/ML (250MG/ML)	SOLUTION / INTRAMUSCULAR	AP	2019-08-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211777-001	HYDROXYPROGESTERONE CAPROATE	250MG/ML (250MG/ML)	SOLUTION / INTRAMUSCULAR	AP	2019-08-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211777-001	HYDROXYPROGESTERONE CAPROATE	250MG/ML (250MG/ML)	SOLUTION / INTRAMUSCULAR	AP	2019-08-08	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211777-001	HYDROXYPROGESTERONE CAPROATE	250MG/ML (250MG/ML)	SOLUTION / INTRAMUSCULAR	AP	2019-08-08	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211777-001	HYDROXYPROGESTERONE CAPROATE	250MG/ML (250MG/ML)	SOLUTION / INTRAMUSCULAR	AP	2019-08-08	`cb3db0bc1861…`

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	A211777-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211777-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211777-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211777-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211777-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211777-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211777-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211777-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211777-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211777-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211777-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211777-001	AP	1	`b00525d2431f…`
2023-01-26 05:58 UTC	2023-01	A211777-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211777-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211777-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211777-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211777-001	AP	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 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

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
67457-967	Hydroxyprogesterone Caproate	Hydroxyprogesterone Caproate	Mylan Institutional LLC	ANDA	Current
67457-967	Hydroxyprogesterone Caproate	Hydroxyprogesterone Caproate	Mylan Institutional LLC	ANDA	Current
73301-001	Hydroxyprogesterone Caproate	Hydroxyprogesterone Caproate	LSNE-LEON SLU	ANDA	Current
73301-001	Hydroxyprogesterone Caproate	Hydroxyprogesterone Caproate	LSNE, Inc	ANDA	Current