Application 090794

Type: ANDA
Sponsor: XIROMED

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ESTARYLLA	ETHINYL ESTRADIOL; NORGESTIMATE	TABLET;ORAL-28	0.035MG;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
A090794-001	ESTARYLLA	ETHINYL ESTRADIOL; NORGESTIMATE	0.035MG;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
A090794-001	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	A090794-001	ESTARYLLA	0.035MG;0.25MG	TABLET / ORAL-28	AB	2013-01-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090794-001	ESTARYLLA	0.035MG;0.25MG	TABLET / ORAL-28	AB	2013-01-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090794-001	ESTARYLLA	0.035MG;0.25MG	TABLET / ORAL-28	AB	2013-01-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090794-001	ESTARYLLA	0.035MG;0.25MG	TABLET / ORAL-28	AB	2013-01-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090794-001	ESTARYLLA	0.035MG;0.25MG	TABLET / ORAL-28	AB	2013-01-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090794-001	ESTARYLLA	0.035MG;0.25MG	TABLET / ORAL-28	AB	2013-01-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090794-001	ESTARYLLA	0.035MG;0.25MG	TABLET / ORAL-28	AB	2013-01-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090794-001	ESTARYLLA	0.035MG;0.25MG	TABLET / ORAL-28	AB	2013-01-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090794-001	ESTARYLLA	0.035MG;0.25MG	TABLET / ORAL-28	AB	2013-01-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090794-001	ESTARYLLA	0.035MG;0.25MG	TABLET / ORAL-28	AB	2013-01-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090794-001	ESTARYLLA	0.035MG;0.25MG	TABLET / ORAL-28	AB	2013-01-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090794-001	ESTARYLLA	0.035MG;0.25MG	TABLET / ORAL-28	AB	2013-01-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090794-001	ESTARYLLA	0.035MG;0.25MG	TABLET / ORAL-28	AB	2013-01-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090794-001	ESTARYLLA	0.035MG;0.25MG	TABLET / ORAL-28	AB	2013-01-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090794-001	ESTARYLLA	0.035MG;0.25MG	TABLET / ORAL-28	AB	2013-01-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090794-001	ESTARYLLA	0.035MG;0.25MG	TABLET / ORAL-28	AB	2013-01-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090794-001	ESTARYLLA	0.035MG;0.25MG	TABLET / ORAL-28	AB	2013-01-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090794-001	ESTARYLLA	0.035MG;0.25MG	TABLET / ORAL-28	AB	2013-01-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090794-001	ESTARYLLA	0.035MG;0.25MG	TABLET / ORAL-28	AB	2013-01-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090794-001	ESTARYLLA	0.035MG;0.25MG	TABLET / ORAL-28	AB	2013-01-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090794-001	ESTARYLLA	0.035MG;0.25MG	TABLET / ORAL-28	AB	2013-01-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090794-001	ESTARYLLA	0.035MG;0.25MG	TABLET / ORAL-28	AB	2013-01-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090794-001	ESTARYLLA	0.035MG;0.25MG	TABLET / ORAL-28	AB	2013-01-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090794-001	ESTARYLLA	0.035MG;0.25MG	TABLET / ORAL-28	AB	2013-01-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090794-001	ESTARYLLA	0.035MG;0.25MG	TABLET / ORAL-28	AB	2013-01-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090794-001	ESTARYLLA	0.035MG;0.25MG	TABLET / ORAL-28	AB	2013-01-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090794-001	ESTARYLLA	0.035MG;0.25MG	TABLET / ORAL-28	AB	2013-01-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090794-001	ESTARYLLA	0.035MG;0.25MG	TABLET / ORAL-28	AB	2013-01-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090794-001	ESTARYLLA	0.035MG;0.25MG	TABLET / ORAL-28	AB	2013-01-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090794-001	ESTARYLLA	0.035MG;0.25MG	TABLET / ORAL-28	AB	2013-01-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090794-001	ESTARYLLA	0.035MG;0.25MG	TABLET / ORAL-28	AB	2013-01-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090794-001	ESTARYLLA	0.035MG;0.25MG	TABLET / ORAL-28	AB	2013-01-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090794-001	ESTARYLLA	0.035MG;0.25MG	TABLET / ORAL-28	AB	2013-01-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090794-001	ESTARYLLA	0.035MG;0.25MG	TABLET / ORAL-28	AB	2013-01-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090794-001	ESTARYLLA	0.035MG;0.25MG	TABLET / ORAL-28	AB	2013-01-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090794-001	ESTARYLLA	0.035MG;0.25MG	TABLET / ORAL-28	AB	2013-01-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090794-001	ESTARYLLA	0.035MG;0.25MG	TABLET / ORAL-28	AB	2013-01-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090794-001	ESTARYLLA	0.035MG;0.25MG	TABLET / ORAL-28	AB	2013-01-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090794-001	ESTARYLLA	0.035MG;0.25MG	TABLET / ORAL-28	AB	2013-01-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090794-001	ESTARYLLA	0.035MG;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	A090794-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090794-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090794-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090794-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090794-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090794-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090794-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090794-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090794-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090794-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090794-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090794-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090794-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090794-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090794-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090794-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090794-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090794-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090794-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090794-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090794-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090794-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090794-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090794-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090794-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090794-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090794-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090794-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090794-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090794-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090794-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090794-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090794-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090794-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090794-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090794-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090794-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090794-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090794-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090794-001	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
Estarylla	NORGESTIMATE AND ETHINYL ESTRADIOL	Bryant Ranch Prepack	e0b07fb6-8dbd-4e5d-b589-5191a1dc02ae	2026-08-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090794 application number: ANDA090794 ndc (product): 63629-2349
Estarylla	NORGESTIMATE AND ETHINYL ESTRADIOL	Proficient Rx LP	7acde5ef-f457-4c47-897b-d048194c7d7e	2024-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090794 application number: ANDA090794
Norgestimate and Ethinyl Estradiol	NORGESTIMATE AND ETHINYL ESTRADIOL	AvKARE	a3c0c983-7ec7-244a-e053-2995a90adbe4	2024-01-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090794 application number: ANDA090794 ndc (product): 42291-553
Estarylla	NORGESTIMATE AND ETHINYL ESTRADIOL	Xiromed, LLC.	7a4d2d7b-b97e-3e18-3d97-1e2579c8f3f8	2023-02-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090794 application number: ANDA090794 ndc (product): 70700-119

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0254-2029	Previfem	Norgestimate and ethinyl estradiol	Par Pharmaceutical, Inc.	ANDA	Current
0254-2029	Previfem	Norgestimate and ethinyl estradiol	Par Pharmaceutical, Inc.	ANDA	Current
0781-4058	Estarylla	Norgestimate and ethinyl estradiol	Sandoz Inc	ANDA	Current
42291-553	Norgestimate and Ethinyl Estradiol	Norgestimate and ethinyl estradiol	AvKARE	ANDA	Current
42291-553	Norgestimate and Ethinyl Estradiol	Norgestimate and ethinyl estradiol	AvKARE	ANDA	Current
53002-2191	Previfem	Norgestimate and ethinyl estradiol	RPK Pharmaceuticals, Inc.	ANDA	Current
63629-2349	Estarylla	Norgestimate and ethinyl estradiol	Bryant Ranch Prepack	ANDA	Current
63629-2349	Estarylla	Norgestimate and ethinyl estradiol	Bryant Ranch Prepack	ANDA	Current
63629-2349	Estarylla	Norgestimate and ethinyl estradiol	Bryant Ranch Prepack	ANDA	Current
70518-2010	Previfem	Norgestimate and ethinyl estradiol	REMEDYREPACK INC.	ANDA	Current
70518-2010	Previfem	Norgestimate and ethinyl estradiol	REMEDYREPACK INC.	ANDA	Current
70518-2010	Previfem	Norgestimate and ethinyl estradiol	REMEDYREPACK INC.	ANDA	Current
70700-119	Estarylla	Norgestimate and ethinyl estradiol	Xiromed, LLC.	ANDA	Current
70700-119	Estarylla	Norgestimate and ethinyl estradiol	Xiromed, LLC.	ANDA	Current
70700-119	Estarylla	Norgestimate and ethinyl estradiol	Xiromed, LLC.	ANDA	Current