Application 090793

Type: ANDA
Sponsor: XIROMED

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TRI-ESTARYLLA	ETHINYL ESTRADIOL; NORGESTIMATE	TABLET;ORAL-28	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A090793-001	TRI-ESTARYLLA	ETHINYL ESTRADIOL; NORGESTIMATE	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB		2013-01-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090793-001	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 2 · 42 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	A090793-001	TRI-ESTARYLLA	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2013-01-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090793-001	TRI-ESTARYLLA	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2013-01-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090793-001	TRI-ESTARYLLA	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2013-01-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090793-001	TRI-ESTARYLLA	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2013-01-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090793-001	TRI-ESTARYLLA	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2013-01-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090793-001	TRI-ESTARYLLA	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2013-01-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090793-001	TRI-ESTARYLLA	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2013-01-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090793-001	TRI-ESTARYLLA	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2013-01-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090793-001	TRI-ESTARYLLA	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2013-01-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090793-001	TRI-ESTARYLLA	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2013-01-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090793-001	TRI-ESTARYLLA	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2013-01-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090793-001	TRI-ESTARYLLA	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2013-01-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090793-001	TRI-ESTARYLLA	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2013-01-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090793-001	TRI-ESTARYLLA	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2013-01-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090793-001	TRI-ESTARYLLA	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2013-01-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090793-001	TRI-ESTARYLLA	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2013-01-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090793-001	TRI-ESTARYLLA	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2013-01-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090793-001	TRI-ESTARYLLA	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2013-01-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090793-001	TRI-ESTARYLLA	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2013-01-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090793-001	TRI-ESTARYLLA	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2013-01-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090793-001	TRI-ESTARYLLA	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2013-01-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090793-001	TRI-ESTARYLLA	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2013-01-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090793-001	TRI-ESTARYLLA	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2013-01-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090793-001	TRI-ESTARYLLA	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2013-01-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090793-001	TRI-ESTARYLLA	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2013-01-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090793-001	TRI-ESTARYLLA	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2013-01-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090793-001	TRI-ESTARYLLA	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2013-01-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090793-001	TRI-ESTARYLLA	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2013-01-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090793-001	TRI-ESTARYLLA	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2013-01-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090793-001	TRI-ESTARYLLA	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2013-01-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090793-001	TRI-ESTARYLLA	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2013-01-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090793-001	TRI-ESTARYLLA	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2013-01-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090793-001	TRI-ESTARYLLA	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2013-01-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090793-001	TRI-ESTARYLLA	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2013-01-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090793-001	TRI-ESTARYLLA	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2013-01-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090793-001	TRI-ESTARYLLA	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2013-01-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090793-001	TRI-ESTARYLLA	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2013-01-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090793-001	TRI-ESTARYLLA	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2013-01-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090793-001	TRI-ESTARYLLA	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2013-01-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090793-001	TRI-ESTARYLLA	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2013-01-30	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 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	A090793-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090793-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090793-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090793-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090793-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090793-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090793-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090793-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090793-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090793-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090793-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090793-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090793-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090793-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090793-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090793-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090793-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090793-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090793-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090793-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090793-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090793-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090793-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090793-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090793-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090793-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090793-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090793-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090793-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090793-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090793-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090793-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090793-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090793-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090793-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090793-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090793-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090793-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090793-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090793-001	AB	1	`e64feba35796…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tri-Estarylla	NORGESTIMATE AND ETHINYL ESTRADIOL	A-S Medication Solutions	f7f7c073-48e0-4065-970b-8103d76b6eb0	2026-01-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090793 application number: ANDA090793
Tri-Estarylla	NORGESTIMATE AND ETHINYL ESTRADIOL	Bryant Ranch Prepack	6560d15f-6ce9-4f0e-9b59-043dec35ddd9	2024-05-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090793 application number: ANDA090793 ndc (product): 63629-2350
norgestimate and ethinyl estradiol	NORGESTIMATE AND ETHINYL ESTRADIOL	AvKARE	a3cfd79e-a344-1dfc-e053-2995a90a1ab7	2024-01-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090793 application number: ANDA090793 ndc (product): 42291-590
Tri-Estarylla	NORGESTIMATE AND ETHINYL ESTRADIOL	Xiromed, LLC.	1ba8a8ab-eb09-0807-47d4-6b4055d10d91	2023-08-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090793 application number: ANDA090793 ndc (product): 70700-121

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
0254-2030	Tri-Previfem	norgestimate and ethinyl estradiol	Par Pharmaceutical, Inc.	ANDA	Current
0254-2030	Tri-Previfem	norgestimate and ethinyl estradiol	Par Pharmaceutical, Inc.	ANDA	Current
0781-4060	Tri-Estarylla	norgestimate and ethinyl estradiol	Sandoz Inc	ANDA	Current
42291-590	norgestimate and ethinyl estradiol	norgestimate and ethinyl estradiol	AvKARE	ANDA	Current
42291-590	norgestimate and ethinyl estradiol	norgestimate and ethinyl estradiol	AvKARE	ANDA	Current
53002-2304	Tri-Previfem	norgestimate and ethinyl estradiol	RPK Pharmaceuticals, Inc.	ANDA	Current
63629-2350	Tri-Estarylla	norgestimate and ethinyl estradiol	Bryant Ranch Prepack	ANDA	Current
63629-2350	Tri-Estarylla	norgestimate and ethinyl estradiol	Bryant Ranch Prepack	ANDA	Current
63629-2350	Tri-Estarylla	norgestimate and ethinyl estradiol	Bryant Ranch Prepack	ANDA	Current
70700-121	Tri-Estarylla	norgestimate and ethinyl estradiol	Xiromed, LLC.	ANDA	Current
70700-121	Tri-Estarylla	norgestimate and ethinyl estradiol	Xiromed, LLC.	ANDA	Current
70700-121	Tri-Estarylla	norgestimate and ethinyl estradiol	Xiromed, LLC.	ANDA	Current
70700-121	Tri-Estarylla	norgestimate and ethinyl estradiol	Xiromed, LLC.	ANDA	Current