Application 021945

Type: NDA
Sponsor: AMAG PHARMA USA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MAKENA	HYDROXYPROGESTERONE CAPROATE	SOLUTION;INTRAMUSCULAR	1250MG/5ML (250MG/ML)	Yes	Yes
002	MAKENA PRESERVATIVE FREE	HYDROXYPROGESTERONE CAPROATE	SOLUTION;INTRAMUSCULAR	250MG/ML (250MG/ML)	Yes	Yes
003	MAKENA PRESERVATIVE FREE	HYDROXYPROGESTERONE CAPROATE	SOLUTION;INTRAMUSCULAR	250MG/ML (250MG/ML)	Yes	No
004	MAKENA (AUTOINJECTOR)	HYDROXYPROGESTERONE CAPROATE	SOLUTION;SUBCUTANEOUS	275MG/1.1ML (250MG/ML)	Yes	Yes

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.

Product history page 1 of 2 · 54 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021945-001	MAKENA	1250MG/5ML (250MG/ML)	SOLUTION / INTRAMUSCULAR	AP1	RLD, RS	2011-02-03	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021945-002	MAKENA PRESERVATIVE FREE	250MG/ML (250MG/ML)	SOLUTION / INTRAMUSCULAR	AP	RLD, RS	2016-02-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021945-004	MAKENA (AUTOINJECTOR)	275MG/1.1ML (250MG/ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2018-02-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021945-001	MAKENA	1250MG/5ML (250MG/ML)	SOLUTION / INTRAMUSCULAR	AP1	RLD, RS	2011-02-03	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021945-002	MAKENA PRESERVATIVE FREE	250MG/ML (250MG/ML)	SOLUTION / INTRAMUSCULAR	AP	RLD, RS	2016-02-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021945-004	MAKENA (AUTOINJECTOR)	275MG/1.1ML (250MG/ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2018-02-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021945-001	MAKENA	1250MG/5ML (250MG/ML)	SOLUTION / INTRAMUSCULAR	AP1	RLD, RS	2011-02-03	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021945-002	MAKENA PRESERVATIVE FREE	250MG/ML (250MG/ML)	SOLUTION / INTRAMUSCULAR	AP	RLD, RS	2016-02-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021945-004	MAKENA (AUTOINJECTOR)	275MG/1.1ML (250MG/ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2018-02-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021945-001	MAKENA	1250MG/5ML (250MG/ML)	SOLUTION / INTRAMUSCULAR	AP1	RLD, RS	2011-02-03	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021945-002	MAKENA PRESERVATIVE FREE	250MG/ML (250MG/ML)	SOLUTION / INTRAMUSCULAR	AP	RLD, RS	2016-02-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021945-004	MAKENA (AUTOINJECTOR)	275MG/1.1ML (250MG/ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2018-02-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021945-001	MAKENA	1250MG/5ML (250MG/ML)	SOLUTION / INTRAMUSCULAR	AP1	RLD, RS	2011-02-03	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021945-002	MAKENA PRESERVATIVE FREE	250MG/ML (250MG/ML)	SOLUTION / INTRAMUSCULAR	AP	RLD, RS	2016-02-19	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021945-004	MAKENA (AUTOINJECTOR)	275MG/1.1ML (250MG/ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2018-02-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021945-001	MAKENA	1250MG/5ML (250MG/ML)	SOLUTION / INTRAMUSCULAR	AP1	RLD, RS	2011-02-03	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021945-002	MAKENA PRESERVATIVE FREE	250MG/ML (250MG/ML)	SOLUTION / INTRAMUSCULAR	AP	RLD, RS	2016-02-19	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021945-004	MAKENA (AUTOINJECTOR)	275MG/1.1ML (250MG/ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2018-02-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021945-001	MAKENA	1250MG/5ML (250MG/ML)	SOLUTION / INTRAMUSCULAR	AP1	RLD, RS	2011-02-03	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021945-002	MAKENA PRESERVATIVE FREE	250MG/ML (250MG/ML)	SOLUTION / INTRAMUSCULAR	AP	RLD, RS	2016-02-19	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021945-004	MAKENA (AUTOINJECTOR)	275MG/1.1ML (250MG/ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2018-02-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021945-001	MAKENA	1250MG/5ML (250MG/ML)	SOLUTION / INTRAMUSCULAR	AP1	RLD, RS	2011-02-03	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021945-002	MAKENA PRESERVATIVE FREE	250MG/ML (250MG/ML)	SOLUTION / INTRAMUSCULAR	AP	RLD, RS	2016-02-19	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021945-004	MAKENA (AUTOINJECTOR)	275MG/1.1ML (250MG/ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2018-02-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021945-001	MAKENA	1250MG/5ML (250MG/ML)	SOLUTION / INTRAMUSCULAR	AP1	RLD, RS	2011-02-03	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021945-002	MAKENA PRESERVATIVE FREE	250MG/ML (250MG/ML)	SOLUTION / INTRAMUSCULAR	AP	RLD, RS	2016-02-19	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021945-004	MAKENA (AUTOINJECTOR)	275MG/1.1ML (250MG/ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2018-02-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021945-001	MAKENA	1250MG/5ML (250MG/ML)	SOLUTION / INTRAMUSCULAR	AP1	RLD, RS	2011-02-03	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021945-002	MAKENA PRESERVATIVE FREE	250MG/ML (250MG/ML)	SOLUTION / INTRAMUSCULAR	AP	RLD, RS	2016-02-19	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021945-004	MAKENA (AUTOINJECTOR)	275MG/1.1ML (250MG/ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2018-02-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021945-001	MAKENA	1250MG/5ML (250MG/ML)	SOLUTION / INTRAMUSCULAR	AP1	RLD, RS	2011-02-03	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021945-002	MAKENA PRESERVATIVE FREE	250MG/ML (250MG/ML)	SOLUTION / INTRAMUSCULAR	AP	RLD, RS	2016-02-19	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021945-004	MAKENA (AUTOINJECTOR)	275MG/1.1ML (250MG/ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2018-02-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021945-001	MAKENA	1250MG/5ML (250MG/ML)	SOLUTION / INTRAMUSCULAR	AP1	RLD, RS	2011-02-03	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021945-002	MAKENA PRESERVATIVE FREE	250MG/ML (250MG/ML)	SOLUTION / INTRAMUSCULAR	AP	RLD, RS	2016-02-19	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021945-004	MAKENA (AUTOINJECTOR)	275MG/1.1ML (250MG/ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2018-02-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021945-001	MAKENA	1250MG/5ML (250MG/ML)	SOLUTION / INTRAMUSCULAR	AP1	RLD, RS	2011-02-03	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021945-002	MAKENA PRESERVATIVE FREE	250MG/ML (250MG/ML)	SOLUTION / INTRAMUSCULAR	AP	RLD, RS	2016-02-19	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021945-004	MAKENA (AUTOINJECTOR)	275MG/1.1ML (250MG/ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2018-02-14	`ea99ee380514…`
2023-01-26 05:58 UTC	2023-01	N021945-001	MAKENA	1250MG/5ML (250MG/ML)	SOLUTION / INTRAMUSCULAR	AP1	RLD, RS	2011-02-03	`3bdfa0b2c4d7…`

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	N021945-001	AP1	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021945-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021945-001	AP1	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021945-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021945-001	AP1	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021945-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021945-001	AP1	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021945-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021945-001	AP1	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021945-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021945-001	AP1	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021945-002	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021945-001	AP1	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021945-002	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021945-001	AP1	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021945-002	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021945-001	AP1	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021945-002	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021945-001	AP1	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021945-002	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021945-001	AP1	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021945-002	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021945-001	AP1	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021945-002	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021945-001	AP1	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021945-002	AP	1	`ea99ee380514…`
2023-01-26 05:58 UTC	2023-01	N021945-001	AP1	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N021945-002	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021945-001	AP1	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021945-002	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021945-001	AP1	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N021945-002	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021945-001	AP1	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N021945-002	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021945-001	AP1	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021945-002	AP	1	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 5 · 165 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021945-004	8562564	2026-01-24		Drug product	2018-03-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021945-004	9180259	2026-01-24		Drug product	2018-03-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021945-004	9533102	2026-01-24		Drug product	2018-03-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021945-004	9629959	2026-01-24		Drug product	2018-03-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021945-004	8021335	2026-10-04		Drug product	2018-03-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021945-004	9789257	2034-02-11		Drug product	2018-03-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021945-004	10471075	2036-05-02	U-2236		2019-11-18	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021945-004	11154562	2036-05-02	U-2236		2021-11-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021945-004	11304962	2036-05-02	U-2236		2022-05-10	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021945-004	9844558	2036-05-02	U-2236		2018-03-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021945-004	8562564	2026-01-24		Drug product	2018-03-02	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021945-004	9180259	2026-01-24		Drug product	2018-03-02	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021945-004	9533102	2026-01-24		Drug product	2018-03-02	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021945-004	9629959	2026-01-24		Drug product	2018-03-02	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021945-004	8021335	2026-10-04		Drug product	2018-03-02	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021945-004	9789257	2034-02-11		Drug product	2018-03-02	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021945-004	10471075	2036-05-02	U-2236		2019-11-18	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021945-004	11154562	2036-05-02	U-2236		2021-11-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021945-004	9844558	2036-05-02	U-2236		2018-03-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021945-004	8562564	2026-01-24		Drug product	2018-03-02	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021945-004	9180259	2026-01-24		Drug product	2018-03-02	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021945-004	9533102	2026-01-24		Drug product	2018-03-02	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021945-004	9629959	2026-01-24		Drug product	2018-03-02	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021945-004	8021335	2026-10-04		Drug product	2018-03-02	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021945-004	9789257	2034-02-11		Drug product	2018-03-02	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021945-004	10471075	2036-05-02	U-2236		2019-11-18	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021945-004	11154562	2036-05-02	U-2236		2021-11-17	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021945-004	9844558	2036-05-02	U-2236		2018-03-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021945-004	RE44846	2019-08-10		Drug product	2018-03-02	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021945-004	8562564	2026-01-24		Drug product	2018-03-02	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021945-004	9180259	2026-01-24		Drug product	2018-03-02	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021945-004	9533102	2026-01-24		Drug product	2018-03-02	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021945-004	9629959	2026-01-24		Drug product	2018-03-02	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021945-004	8021335	2026-10-04		Drug product	2018-03-02	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021945-004	9789257	2034-02-11		Drug product	2018-03-02	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021945-004	9844558	2036-05-02	U-2236		2018-03-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021945-004	8562564	2026-01-24		Drug product	2018-03-02	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021945-004	9180259	2026-01-24		Drug product	2018-03-02	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021945-004	9533102	2026-01-24		Drug product	2018-03-02	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021945-004	9629959	2026-01-24		Drug product	2018-03-02	`bb7c543d1eb4…`

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 generic name: HYDROXYPROGESTERONE CAPROATE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 13 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
64011-243	Makena	hydroxyprogesterone caproate	AMAG Pharmaceuticals, Inc.	NDA	Current
64011-243	Makena	hydroxyprogesterone caproate	AMAG Pharmaceuticals, Inc.	NDA	Current
64011-243	Makena	hydroxyprogesterone caproate	AMAG Pharmaceuticals, Inc.	NDA	Current
64011-247	Makena	hydroxyprogesterone caproate	AMAG Pharmaceuticals, Inc.	NDA	Current
64011-247	Makena	hydroxyprogesterone caproate	AMAG Pharmaceuticals, Inc.	NDA	Current
64011-247	Makena	hydroxyprogesterone caproate	AMAG Pharmaceuticals, Inc.	NDA	Current
64011-301	Makena	hydroxyprogesterone caproate	AMAG Pharmaceuticals, Inc.	NDA	Current
64011-301	Makena	hydroxyprogesterone caproate	AMAG Pharmaceuticals, Inc.	NDA	Current
64011-301	Makena	hydroxyprogesterone caproate	AMAG Pharmaceuticals, Inc.	NDA	Current
66993-038	Hydroxyprogesterone Caproate	hydroxyprogesterone caproate	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-038	Hydroxyprogesterone Caproate	hydroxyprogesterone caproate	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-039	Hydroxyprogesterone Caproate	hydroxyprogesterone caproate	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-039	Hydroxyprogesterone Caproate	hydroxyprogesterone caproate	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
58983	SUPPL	2019-06-06
55073	SUPPL	2018-08-02
52649	SUPPL	2018-02-15
52648	SUPPL	2018-02-15
49490	SUPPL	2017-08-21
49440	SUPPL	2017-08-17
6514	SUPPL	2013-09-17
16618	SUPPL	2013-09-16
44660	ORIG	2012-10-31
21881	ORIG	2012-10-31
6513	ORIG	2011-02-10
37933	ORIG	2011-02-03
53292	ORIG	1900-01-01
53291	ORIG	1900-01-01
53290	ORIG	1900-01-01