Application 207724

Type: ANDA
Sponsor: AMNEAL PHARMS NY

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PROGESTERONE	PROGESTERONE	CAPSULE;ORAL	100MG	No	No
002	PROGESTERONE	PROGESTERONE	CAPSULE;ORAL	200MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A207724-001	PROGESTERONE	PROGESTERONE	100MG	CAPSULE / ORAL	AB		2017-09-07
A207724-002	PROGESTERONE	PROGESTERONE	200MG	CAPSULE / ORAL	AB		2017-09-07

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A207724-001	AB
A207724-002	AB

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 3 · 84 observed 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
2026-08-18 06:07:40	2026-07	A207724-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2017-09-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207724-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2017-09-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207724-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2017-09-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207724-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2017-09-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207724-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2017-09-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207724-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2017-09-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207724-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2017-09-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207724-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2017-09-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207724-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2017-09-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207724-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2017-09-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207724-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2017-09-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207724-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2017-09-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207724-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2017-09-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207724-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2017-09-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207724-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2017-09-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207724-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2017-09-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207724-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2017-09-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207724-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2017-09-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207724-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2017-09-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207724-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2017-09-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207724-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2017-09-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207724-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2017-09-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207724-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2017-09-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207724-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2017-09-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207724-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2017-09-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207724-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2017-09-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207724-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2017-09-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207724-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2017-09-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207724-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2017-09-07	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207724-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2017-09-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207724-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2017-09-07	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207724-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2017-09-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207724-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2017-09-07	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207724-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2017-09-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207724-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2017-09-07	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207724-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2017-09-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207724-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2017-09-07	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207724-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2017-09-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207724-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2017-09-07	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207724-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2017-09-07	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A207724-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207724-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207724-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207724-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207724-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207724-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207724-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207724-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207724-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207724-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207724-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207724-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207724-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207724-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207724-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207724-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207724-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207724-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207724-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207724-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207724-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207724-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207724-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207724-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207724-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207724-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207724-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207724-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207724-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207724-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207724-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207724-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207724-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207724-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207724-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207724-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207724-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207724-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207724-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207724-002	AB	1	`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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Progesterone	PROGESTERONE	AvKARE	42c84fec-e5eb-78f7-e063-6294a90a4c0e	2026-06-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207724 application number: ANDA207724
Progesterone	PROGESTERONE	Amneal Pharmaceuticals LLC	4de0715d-a3b9-42fa-b4e4-6371151fd75c	2026-02-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207724 application number: ANDA207724 ndc (product): 65162-808 ndc (product): 65162-807
Progesterone	PROGESTERONE	REMEDYREPACK INC.	d7619751-47b4-47c9-b716-e2a704b350c8	2026-01-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207724 application number: ANDA207724
Progesterone	PROGESTERONE	Bryant Ranch Prepack	1220b231-4765-4879-acb8-d7887d863a28	2024-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207724 application number: ANDA207724 ndc (product): 71335-1432
Progesterone	PROGESTERONE	Asclemed USA, Inc.	19716042-8025-43a3-b26d-e0fd7d2587eb	2022-10-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207724 application number: ANDA207724 ndc (product): 76420-058 ndc (product): 76420-059

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-4656	Progesterone	Progesterone	A-S Medication Solutions	ANDA	Current
50090-4656	Progesterone	Progesterone	A-S Medication Solutions	ANDA	Current
65162-807	Progesterone	Progesterone	Amneal Pharmaceuticals LLC	ANDA	Current
65162-807	Progesterone	Progesterone	Amneal Pharmaceuticals LLC	ANDA	Current
65162-807	Progesterone	Progesterone	Amneal Pharmaceuticals LLC	ANDA	Current
65162-807	Progesterone	Progesterone	Amneal Pharmaceuticals LLC	ANDA	Current
65162-808	Progesterone	Progesterone	Amneal Pharmaceuticals LLC	ANDA	Current
65162-808	Progesterone	Progesterone	Amneal Pharmaceuticals LLC	ANDA	Current
65162-808	Progesterone	Progesterone	Amneal Pharmaceuticals LLC	ANDA	Current
65162-808	Progesterone	Progesterone	Amneal Pharmaceuticals LLC	ANDA	Current
71335-1430	Progesterone	Progesterone	Bryant Ranch Prepack	ANDA	Current
71335-1430	Progesterone	Progesterone	Bryant Ranch Prepack	ANDA	Current
71335-1432	Progesterone	Progesterone	Bryant Ranch Prepack	ANDA	Current
71335-1432	Progesterone	Progesterone	Bryant Ranch Prepack	ANDA	Current
76420-058	Progesterone	Progesterone	Asclemed USA, Inc.	ANDA	Current
76420-058	Progesterone	Progesterone	Asclemed USA, Inc.	ANDA	Current
76420-059	Progesterone	Progesterone	Asclemed USA, Inc.	ANDA	Current
76420-059	Progesterone	Progesterone	Asclemed USA, Inc.	ANDA	Current