Application 205229

Type: ANDA
Sponsor: XIROMED

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
A205229-001	PROGESTERONE	PROGESTERONE	100MG	CAPSULE / ORAL	AB		2017-10-20
A205229-002	PROGESTERONE	PROGESTERONE	200MG	CAPSULE / ORAL	AB		2017-10-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205229-001	AB
A205229-002	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	A205229-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2017-10-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205229-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2017-10-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205229-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2017-10-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205229-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2017-10-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205229-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2017-10-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205229-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2017-10-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205229-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2017-10-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205229-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2017-10-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205229-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2017-10-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205229-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2017-10-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205229-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2017-10-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205229-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2017-10-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205229-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2017-10-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205229-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2017-10-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205229-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2017-10-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205229-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2017-10-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205229-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2017-10-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205229-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2017-10-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205229-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2017-10-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205229-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2017-10-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205229-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2017-10-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205229-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2017-10-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205229-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2017-10-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205229-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2017-10-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205229-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2017-10-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205229-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2017-10-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205229-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2017-10-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205229-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2017-10-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205229-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2017-10-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205229-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2017-10-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205229-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2017-10-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205229-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2017-10-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205229-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2017-10-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205229-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2017-10-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205229-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2017-10-20	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205229-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2017-10-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205229-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2017-10-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205229-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2017-10-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205229-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2017-10-20	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205229-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2017-10-20	`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	A205229-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205229-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205229-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205229-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205229-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205229-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205229-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205229-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205229-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205229-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205229-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205229-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205229-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205229-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205229-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205229-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205229-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205229-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205229-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205229-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205229-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205229-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205229-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205229-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205229-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205229-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205229-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205229-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205229-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205229-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205229-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205229-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205229-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205229-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205229-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205229-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205229-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205229-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205229-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205229-002	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 · 16 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Progesterone	PROGESTERONE	Redpharm Drug	5743b2e4-093f-c59a-e063-6394a90aae2b	2026-07-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205229 application number: ANDA205229
Progesterone	PROGESTERONE	Bryant Ranch Prepack	1ba10f9d-6e91-4954-ac91-23adcf8805b0	2026-06-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205229 application number: ANDA205229 ndc (product): 71335-1913
Progesterone	PROGESTERONE	Bryant Ranch Prepack	74a7619a-8f74-4889-96f6-5bae478543e8	2026-06-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205229 application number: ANDA205229 ndc (product): 71335-1990
Progesterone	PROGESTERONE	AvKARE	1637ac18-3a37-f3d5-e063-6394a90af157	2026-05-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205229 application number: ANDA205229
Progesterone	PROGESTERONE	Northstar Rx LLC	73229a76-8de3-4cea-886f-568f0b817fea	2026-02-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205229 application number: ANDA205229 ndc (product): 16714-158 ndc (product): 16714-157
Progesterone	PROGESTERONE	Xiromed, LLC	0bf317a8-96d6-849d-7850-9084205a5315	2026-02-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205229 application number: ANDA205229 ndc (product): 70700-163 ndc (product): 70700-162
Progesterone	PROGESTERONE	Direct_Rx	462ae686-7264-4852-e063-6294a90aae98	2025-12-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205229 application number: ANDA205229
Progesterone	PROGESTERONE	Preferred Pharmaceuticals Inc.	67842863-209d-4724-9e67-8d0c6282bd1d	2025-09-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205229 application number: ANDA205229 ndc (product): 68788-8296 ndc (product): 68788-8295
PROGESTERONE	PROGESTERONE	Direct Rx	dc9e2088-e11e-7d32-e053-2a95a90a2995	2025-01-22	Warnings	Exact identifier application applno (ANDA): 205229 application number: ANDA205229 ndc (product): 72189-347
Progesterone	PROGESTERONE	Proficient Rx LP	80a63b2b-96be-423d-abbd-13acc802f6da	2024-06-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205229 application number: ANDA205229 ndc (product): 71205-669
Progesterone	PROGESTERONE	A-S Medication Solutions	96c59a1c-d562-46dd-868b-b2decdfef319	2023-11-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205229 application number: ANDA205229
Progesterone	PROGESTERONE	Asclemed USA, Inc.	fd6b9861-04fc-42d8-90c8-021a69fe93e9	2023-07-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205229 application number: ANDA205229 ndc (product): 76420-267
Progesterone	PROGESTERONE	A-S Medication Solutions	5e0263c5-2cb6-4e02-b883-2c05492a6260	2023-05-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205229 application number: ANDA205229
Progesterone	PROGESTERONE	Asclemed USA, Inc.	4a741977-1dbb-41e7-a560-9ac02936f8b1	2022-09-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205229 application number: ANDA205229 ndc (product): 76420-282 ndc (product): 76420-281
Progesterone	PROGESTERONE	Proficient Rx LP	e1546b35-cfa8-4808-9652-db1ba675a4e3	2022-08-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205229 application number: ANDA205229 ndc (product): 71205-684
Progesterone	PROGESTERONE	Proficient Rx LP	73e65b35-2266-48a3-98f8-521446a55c22	2022-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205229 application number: ANDA205229 ndc (product): 71205-903 ndc (product): 71205-902

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 29 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16714-157	Progesterone	Progesterone	Northstar Rx LLC	ANDA	Current
16714-158	Progesterone	Progesterone	Northstar Rx LLC	ANDA	Current
68071-2768	Progesterone	Progesterone	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2770	Progesterone	Progesterone	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2832	Progesterone	Progesterone	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2840	Progesterone	Progesterone	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2840	Progesterone	Progesterone	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-8295	Progesterone	Progesterone	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-8296	Progesterone	Progesterone	Preferred Pharmaceuticals Inc.	ANDA	Current
70518-3286	Progesterone	Progesterone	REMEDYREPACK INC.	ANDA	Current
70700-162	Progesterone	Progesterone	Xiromed, LLC	ANDA	Current
70700-162	Progesterone	Progesterone	Xiromed, LLC	ANDA	Current
70700-163	Progesterone	Progesterone	Xiromed, LLC	ANDA	Current
70700-163	Progesterone	Progesterone	Xiromed, LLC	ANDA	Current
70934-914	Progesterone	Progesterone	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
71205-669	Progesterone	Progesterone	Proficient Rx LP	ANDA	Current
71205-684	Progesterone	Progesterone	Proficient Rx LP	ANDA	Current
71205-902	Progesterone	Progesterone	Proficient Rx LP	ANDA	Current
71205-902	Progesterone	Progesterone	Proficient Rx LP	ANDA	Current
71205-903	Progesterone	Progesterone	Proficient Rx LP	ANDA	Current
71205-903	Progesterone	Progesterone	Proficient Rx LP	ANDA	Current
71335-1913	Progesterone	Progesterone	Bryant Ranch Prepack	ANDA	Current
71335-1990	Progesterone	Progesterone	Bryant Ranch Prepack	ANDA	Current
71335-1990	Progesterone	Progesterone	Bryant Ranch Prepack	ANDA	Current
72189-347	PROGESTERONE	PROGESTERONE	Direct Rx	ANDA	Current
72189-347	PROGESTERONE	PROGESTERONE	Direct Rx	ANDA	Current
76420-267	Progesterone	Progesterone	Asclemed USA, Inc.	ANDA	Current
76420-281	Progesterone	Progesterone	Asclemed USA, Inc.	ANDA	Current
76420-282	Progesterone	Progesterone	Asclemed USA, Inc.	ANDA	Current