Application 090523

Type: ANDA
Sponsor: NOVAST LABS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MONO-LINYAH	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
A090523-001	MONO-LINYAH	ETHINYL ESTRADIOL; NORGESTIMATE	0.035MG;0.25MG	TABLET / ORAL-28	AB		2012-05-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090523-001	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	A090523-001	MONO-LINYAH	0.035MG;0.25MG	TABLET / ORAL-28	AB	2012-05-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090523-001	MONO-LINYAH	0.035MG;0.25MG	TABLET / ORAL-28	AB	2012-05-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090523-001	MONO-LINYAH	0.035MG;0.25MG	TABLET / ORAL-28	AB	2012-05-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090523-001	MONO-LINYAH	0.035MG;0.25MG	TABLET / ORAL-28	AB	2012-05-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090523-001	MONO-LINYAH	0.035MG;0.25MG	TABLET / ORAL-28	AB	2012-05-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090523-001	MONO-LINYAH	0.035MG;0.25MG	TABLET / ORAL-28	AB	2012-05-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090523-001	MONO-LINYAH	0.035MG;0.25MG	TABLET / ORAL-28	AB	2012-05-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090523-001	MONO-LINYAH	0.035MG;0.25MG	TABLET / ORAL-28	AB	2012-05-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090523-001	MONO-LINYAH	0.035MG;0.25MG	TABLET / ORAL-28	AB	2012-05-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090523-001	MONO-LINYAH	0.035MG;0.25MG	TABLET / ORAL-28	AB	2012-05-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090523-001	MONO-LINYAH	0.035MG;0.25MG	TABLET / ORAL-28	AB	2012-05-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090523-001	MONO-LINYAH	0.035MG;0.25MG	TABLET / ORAL-28	AB	2012-05-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090523-001	MONO-LINYAH	0.035MG;0.25MG	TABLET / ORAL-28	AB	2012-05-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090523-001	MONO-LINYAH	0.035MG;0.25MG	TABLET / ORAL-28	AB	2012-05-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090523-001	MONO-LINYAH	0.035MG;0.25MG	TABLET / ORAL-28	AB	2012-05-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090523-001	MONO-LINYAH	0.035MG;0.25MG	TABLET / ORAL-28	AB	2012-05-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090523-001	MONO-LINYAH	0.035MG;0.25MG	TABLET / ORAL-28	AB	2012-05-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090523-001	MONO-LINYAH	0.035MG;0.25MG	TABLET / ORAL-28	AB	2012-05-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090523-001	MONO-LINYAH	0.035MG;0.25MG	TABLET / ORAL-28	AB	2012-05-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090523-001	MONO-LINYAH	0.035MG;0.25MG	TABLET / ORAL-28	AB	2012-05-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090523-001	MONO-LINYAH	0.035MG;0.25MG	TABLET / ORAL-28	AB	2012-05-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090523-001	MONO-LINYAH	0.035MG;0.25MG	TABLET / ORAL-28	AB	2012-05-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090523-001	MONO-LINYAH	0.035MG;0.25MG	TABLET / ORAL-28	AB	2012-05-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090523-001	MONO-LINYAH	0.035MG;0.25MG	TABLET / ORAL-28	AB	2012-05-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090523-001	MONO-LINYAH	0.035MG;0.25MG	TABLET / ORAL-28	AB	2012-05-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090523-001	MONO-LINYAH	0.035MG;0.25MG	TABLET / ORAL-28	AB	2012-05-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090523-001	MONO-LINYAH	0.035MG;0.25MG	TABLET / ORAL-28	AB	2012-05-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090523-001	MONO-LINYAH	0.035MG;0.25MG	TABLET / ORAL-28	AB	2012-05-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090523-001	MONO-LINYAH	0.035MG;0.25MG	TABLET / ORAL-28	AB	2012-05-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090523-001	MONO-LINYAH	0.035MG;0.25MG	TABLET / ORAL-28	AB	2012-05-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090523-001	MONO-LINYAH	0.035MG;0.25MG	TABLET / ORAL-28	AB	2012-05-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090523-001	MONO-LINYAH	0.035MG;0.25MG	TABLET / ORAL-28	AB	2012-05-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090523-001	MONO-LINYAH	0.035MG;0.25MG	TABLET / ORAL-28	AB	2012-05-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090523-001	MONO-LINYAH	0.035MG;0.25MG	TABLET / ORAL-28	AB	2012-05-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090523-001	MONO-LINYAH	0.035MG;0.25MG	TABLET / ORAL-28	AB	2012-05-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090523-001	MONO-LINYAH	0.035MG;0.25MG	TABLET / ORAL-28	AB	2012-05-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090523-001	MONO-LINYAH	0.035MG;0.25MG	TABLET / ORAL-28	AB	2012-05-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090523-001	MONO-LINYAH	0.035MG;0.25MG	TABLET / ORAL-28	AB	2012-05-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090523-001	MONO-LINYAH	0.035MG;0.25MG	TABLET / ORAL-28	AB	2012-05-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090523-001	MONO-LINYAH	0.035MG;0.25MG	TABLET / ORAL-28	AB	2012-05-23	`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	A090523-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090523-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090523-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090523-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090523-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090523-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090523-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090523-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090523-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090523-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090523-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090523-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090523-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090523-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090523-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090523-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090523-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090523-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090523-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090523-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090523-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090523-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090523-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090523-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090523-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090523-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090523-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090523-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090523-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090523-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090523-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090523-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090523-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090523-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090523-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090523-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090523-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090523-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090523-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090523-001	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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MONO-LINYAH	NORGESTIMATE AND ETHINYL ESTRADIOL	A-S Medication Solutions	2ec8f18f-297c-405f-b191-a40767366bad	2026-06-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090523 application number: ANDA090523 ndc (product): 50090-4881
Mono-Linyah	NORGESTIMATE AND ETHINYL ESTRADIOL	Northstar Rx LLC	84a20017-344b-4684-a915-c85a55fcbbcb	2025-01-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090523 application number: ANDA090523 ndc (product): 16714-360
Nymyo	NORGESTIMATE AND ETHINYL ESTRADIOL	Mayne Pharma Inc.	a522aff5-b02f-4e18-bf59-40bb0399e6fe	2022-12-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090523 application number: ANDA090523 ndc (product): 51862-645

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16714-360	Mono-Linyah	norgestimate and ethinyl estradiol	Northstar Rx LLC	ANDA	Current
50090-3426	Mono-Linyah	norgestimate and ethinyl estradiol	A-S Medication Solutions	ANDA	Current
50090-4881	Mono-Linyah	norgestimate and ethinyl estradiol	A-S Medication Solutions	ANDA	Current
51862-645	Nymyo	norgestimate and ethinyl estradiol	Mayne Pharma Inc.	ANDA	Current
51862-645	Nymyo	norgestimate and ethinyl estradiol	Mayne Pharma Inc.	ANDA	Current