Application 090541

Type: ANDA
Sponsor: NOVAST LABS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TRI-LO-LINYAH	NORGESTIMATE; ETHINYL ESTRADIOL	TABLET; ORAL	0.18MG; 0.025MG	No	No
002	TRI-LO-LINYAH	NORGESTIMATE; ETHINYL ESTRADIOL	TABLET; ORAL	0.215MG; 0.025MG	No	No
003	TRI-LO-LINYAH	NORGESTIMATE; ETHINYL ESTRADIOL	TABLET; ORAL	0.25MG; 0.025MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A090541-001	TRI-LO-LINYAH	ETHINYL ESTRADIOL; NORGESTIMATE	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB		2022-09-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090541-001	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.

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	A090541-001	TRI-LO-LINYAH	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2022-09-02	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090541-001	TRI-LO-LINYAH	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2022-09-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090541-001	TRI-LO-LINYAH	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2022-09-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090541-001	TRI-LO-LINYAH	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2022-09-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090541-001	TRI-LO-LINYAH	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2022-09-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090541-001	TRI-LO-LINYAH	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2022-09-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090541-001	TRI-LO-LINYAH	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2022-09-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090541-001	TRI-LO-LINYAH	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2022-09-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090541-001	TRI-LO-LINYAH	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2022-09-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090541-001	TRI-LO-LINYAH	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2022-09-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090541-001	TRI-LO-LINYAH	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2022-09-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090541-001	TRI-LO-LINYAH	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2022-09-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090541-001	TRI-LO-LINYAH	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2022-09-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090541-001	TRI-LO-LINYAH	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2022-09-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090541-001	TRI-LO-LINYAH	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2022-09-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090541-001	TRI-LO-LINYAH	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2022-09-02	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090541-001	TRI-LO-LINYAH	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2022-09-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090541-001	TRI-LO-LINYAH	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2022-09-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090541-001	TRI-LO-LINYAH	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2022-09-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090541-001	TRI-LO-LINYAH	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2022-09-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090541-001	TRI-LO-LINYAH	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2022-09-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090541-001	TRI-LO-LINYAH	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2022-09-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090541-001	TRI-LO-LINYAH	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2022-09-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090541-001	TRI-LO-LINYAH	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2022-09-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090541-001	TRI-LO-LINYAH	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2022-09-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090541-001	TRI-LO-LINYAH	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2022-09-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090541-001	TRI-LO-LINYAH	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2022-09-02	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090541-001	TRI-LO-LINYAH	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2022-09-02	`e64feba35796…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A090541-001	TRI-LO-LINYAH	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2022-09-02	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A090541-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090541-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090541-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090541-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090541-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090541-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090541-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090541-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090541-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090541-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090541-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090541-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090541-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090541-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090541-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090541-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090541-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090541-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090541-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090541-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090541-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090541-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090541-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090541-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090541-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090541-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090541-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090541-001	AB	1	`e64feba35796…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A090541-001	AB	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.