Application 200900

Type: ANDA
Sponsor: BIONPHARMA INC

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 43.

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
A200900-001	PROGESTERONE	PROGESTERONE	100MG	CAPSULE / ORAL	AB		2013-08-16
A200900-002	PROGESTERONE	PROGESTERONE	200MG	CAPSULE / ORAL	AB		2013-08-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A200900-001	AB
A200900-002	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 · 86 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
2026-09-14 22:38:34	2026-08	A200900-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2013-08-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A200900-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2013-08-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A200900-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2013-08-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200900-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2013-08-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200900-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2013-08-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200900-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2013-08-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200900-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2013-08-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200900-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2013-08-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200900-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2013-08-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200900-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2013-08-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200900-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2013-08-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200900-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2013-08-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200900-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2013-08-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200900-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2013-08-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200900-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2013-08-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200900-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2013-08-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200900-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2013-08-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200900-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2013-08-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200900-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2013-08-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200900-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2013-08-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200900-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2013-08-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200900-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2013-08-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200900-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2013-08-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200900-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2013-08-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200900-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2013-08-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200900-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2013-08-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200900-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2013-08-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200900-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2013-08-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200900-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2013-08-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200900-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2013-08-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200900-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2013-08-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A200900-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2013-08-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200900-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2013-08-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200900-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2013-08-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200900-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2013-08-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A200900-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2013-08-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200900-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2013-08-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A200900-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2013-08-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200900-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2013-08-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A200900-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2013-08-16	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-03-09 01:35 UTC	2022-03	A200900-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A200900-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200900-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A200900-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200900-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200900-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A200900-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A200900-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A200900-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A200900-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A200900-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A200900-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A200900-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A200900-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A200900-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A200900-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A200900-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A200900-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200900-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200900-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A200900-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A200900-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A200900-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A200900-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A200900-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A200900-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A200900-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A200900-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A200900-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A200900-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A200900-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A200900-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A200900-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A200900-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A200900-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A200900-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A200900-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A200900-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A200900-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A200900-002	AB	1	`f41ea6bd6efb…`

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 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PROGESTERONE	PROGESTERONE	REMEDYREPACK INC.	947ebb7c-492b-4b83-aa1c-81e282df6421	2026-08-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200900 application number: ANDA200900
PROGESTERONE	PROGESTERONE	Preferred Pharmaceuticals Inc.	404e0b45-339b-4304-8e33-5f4ffe8f8e25	2026-08-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200900 application number: ANDA200900
PROGESTERONE	PROGESTERONE	Golden State Medical Supply, Inc.	312db3af-9dd2-d5e4-e063-6394a90af999	2026-06-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200900 application number: ANDA200900
PROGESTERONE	PROGESTERONE	Bionpharma Inc.	41b3c3a7-5fb8-4451-a96c-2bd02613c021	2026-05-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200900 application number: ANDA200900 ndc (product): 69452-233 ndc (product): 69452-234
PROGESTERONE	PROGESTERONE	A-S Medication Solutions	566584fc-c76a-4e42-a62e-109a2903b939	2026-05-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200900 application number: ANDA200900
PROGESTERONE	PROGESTERONE	Proficient Rx LP	199c8575-e113-468f-8eb7-c4930030649c	2026-02-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200900 application number: ANDA200900
PROGESTERONE	PROGESTERONE	Bryant Ranch Prepack	46d97ca6-970f-478f-81ff-1b9a9f6cb2f7	2026-01-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200900 application number: ANDA200900
PROGESTERONE	PROGESTERONE	NuCare Pharmaceuticals,Inc.	0b3da881-4720-cdee-e063-6394a90aee99	2025-11-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200900 application number: ANDA200900
PROGESTERONE	PROGESTERONE	Preferred Pharmaceuticals Inc.	41c9546c-a854-4395-9506-d1be61f4e60f	2025-09-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200900 application number: ANDA200900
PROGESTERONE	PROGESTERONE	Bryant Ranch Prepack	0aeb0f0f-2749-416b-942f-83950200fd75	2025-05-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200900 application number: ANDA200900
PROGESTERONE	PROGESTERONE	Asclemed USA, Inc.	342a096d-df6f-47de-bdd1-ec259638e476	2025-05-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200900 application number: ANDA200900
PROGESTERONE	PROGESTERONE	NuCare Pharmaceuticals,Inc.	0d976866-81b3-5db8-e063-6294a90a39f9	2024-07-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200900 application number: ANDA200900
PROGESTERONE	PROGESTERONE	Bionpharma Inc.	3acad9b0-7ec6-4d5e-9852-32ffadbbed6d	2018-03-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200900 application number: ANDA200900 ndc (product): 69452-148 ndc (product): 69452-149

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 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10888-7135	PROGESTERONE	PROGESTERONE	Banner Pharmacaps	ANDA	Current
10888-7136	PROGESTERONE	PROGESTERONE	Banner Pharmacaps	ANDA	Current
42291-690	PROGESTERONE	PROGESTERONE	AvKARE, Inc.	ANDA	Current
50090-2325	PROGESTERONE	PROGESTERONE	A-S Medication Solutions	ANDA	Current
68071-2134	PROGESTERONE	PROGESTERONE	NuCare Pharmaceuticals,Inc.	ANDA	Current
69387-101	PROGESTERONE	PROGESTERONE	Banner Life Sciences LLC.	ANDA	Current
69387-102	PROGESTERONE	PROGESTERONE	Banner Life Sciences LLC.	ANDA	Current
69452-148	PROGESTERONE	PROGESTERONE	Bionpharma Inc.	ANDA	Current
69452-149	PROGESTERONE	PROGESTERONE	Bionpharma Inc.	ANDA	Current
69452-233	PROGESTERONE	PROGESTERONE	Bionpharma Inc.	ANDA	Current
69452-234	PROGESTERONE	PROGESTERONE	Bionpharma Inc.	ANDA	Current