Application 200541

Type: ANDA
Sponsor: LUPIN PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NORGESTIMATE AND ETHINYL ESTRADIOL	ETHINYL ESTRADIOL; NORGESTIMATE	TABLET;ORAL-28	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A200541-001	NORGESTIMATE AND ETHINYL ESTRADIOL	ETHINYL ESTRADIOL; NORGESTIMATE	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB		2012-06-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A200541-001	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 · 41 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
2026-02-19 14:30 UTC	2026-02	A200541-001	NORGESTIMATE AND ETHINYL ESTRADIOL	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2012-06-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200541-001	NORGESTIMATE AND ETHINYL ESTRADIOL	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2012-06-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200541-001	NORGESTIMATE AND ETHINYL ESTRADIOL	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2012-06-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200541-001	NORGESTIMATE AND ETHINYL ESTRADIOL	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2012-06-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200541-001	NORGESTIMATE AND ETHINYL ESTRADIOL	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2012-06-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200541-001	NORGESTIMATE AND ETHINYL ESTRADIOL	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2012-06-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200541-001	NORGESTIMATE AND ETHINYL ESTRADIOL	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2012-06-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200541-001	NORGESTIMATE AND ETHINYL ESTRADIOL	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2012-06-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200541-001	NORGESTIMATE AND ETHINYL ESTRADIOL	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2012-06-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200541-001	NORGESTIMATE AND ETHINYL ESTRADIOL	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2012-06-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200541-001	NORGESTIMATE AND ETHINYL ESTRADIOL	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2012-06-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200541-001	NORGESTIMATE AND ETHINYL ESTRADIOL	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2012-06-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200541-001	NORGESTIMATE AND ETHINYL ESTRADIOL	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2012-06-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200541-001	NORGESTIMATE AND ETHINYL ESTRADIOL	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2012-06-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200541-001	NORGESTIMATE AND ETHINYL ESTRADIOL	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2012-06-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200541-001	NORGESTIMATE AND ETHINYL ESTRADIOL	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2012-06-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200541-001	NORGESTIMATE AND ETHINYL ESTRADIOL	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2012-06-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200541-001	NORGESTIMATE AND ETHINYL ESTRADIOL	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2012-06-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200541-001	NORGESTIMATE AND ETHINYL ESTRADIOL	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2012-06-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200541-001	NORGESTIMATE AND ETHINYL ESTRADIOL	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2012-06-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200541-001	NORGESTIMATE AND ETHINYL ESTRADIOL	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2012-06-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A200541-001	NORGESTIMATE AND ETHINYL ESTRADIOL	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2012-06-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A200541-001	NORGESTIMATE AND ETHINYL ESTRADIOL	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2012-06-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A200541-001	NORGESTIMATE AND ETHINYL ESTRADIOL	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2012-06-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A200541-001	NORGESTIMATE AND ETHINYL ESTRADIOL	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2012-06-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A200541-001	NORGESTIMATE AND ETHINYL ESTRADIOL	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2012-06-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A200541-001	NORGESTIMATE AND ETHINYL ESTRADIOL	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2012-06-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200541-001	NORGESTIMATE AND ETHINYL ESTRADIOL	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2012-06-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A200541-001	NORGESTIMATE AND ETHINYL ESTRADIOL	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2012-06-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A200541-001	NORGESTIMATE AND ETHINYL ESTRADIOL	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2012-06-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A200541-001	NORGESTIMATE AND ETHINYL ESTRADIOL	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2012-06-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A200541-001	NORGESTIMATE AND ETHINYL ESTRADIOL	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2012-06-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A200541-001	NORGESTIMATE AND ETHINYL ESTRADIOL	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2012-06-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A200541-001	NORGESTIMATE AND ETHINYL ESTRADIOL	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2012-06-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A200541-001	NORGESTIMATE AND ETHINYL ESTRADIOL	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2012-06-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A200541-001	NORGESTIMATE AND ETHINYL ESTRADIOL	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2012-06-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A200541-001	NORGESTIMATE AND ETHINYL ESTRADIOL	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2012-06-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A200541-001	NORGESTIMATE AND ETHINYL ESTRADIOL	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2012-06-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A200541-001	NORGESTIMATE AND ETHINYL ESTRADIOL	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2012-06-25	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A200541-001	NORGESTIMATE AND ETHINYL ESTRADIOL	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2012-06-25	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A200541-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200541-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200541-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200541-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200541-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200541-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200541-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200541-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200541-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200541-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200541-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200541-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200541-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200541-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200541-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200541-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200541-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200541-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200541-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200541-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200541-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A200541-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A200541-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A200541-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A200541-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A200541-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A200541-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200541-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A200541-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A200541-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A200541-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A200541-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A200541-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A200541-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A200541-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A200541-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A200541-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A200541-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A200541-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A200541-001	AB	1	`cb3db0bc1861…`

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
norgestimate and ethinyl estradiol	NORGESTIMATE AND ETHINYL ESTRADIOL	PD-Rx Pharmaceuticals, Inc.	2385591b-70ee-0577-e063-6394a90a9357	2026-07-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200541 application number: ANDA200541
TRI-LO-MARZIA	NORGESTIMATE AND ETHINYL ESTRADIOL	Lupin Pharmaceuticals, Inc.	bc402baa-5de4-4149-9857-081a9b4eb280	2025-12-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200541 application number: ANDA200541 ndc (product): 68180-837
TRI-LO-MARZIA	NORGESTIMATE AND ETHINYL ESTRADIOL	A-S Medication Solutions	4d888008-cc14-4291-b384-0d482f48eb08	2024-03-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200541 application number: ANDA200541 ndc (product): 50090-2429
TRI-LO-MARZIA	NORGESTIMATE AND ETHINYL ESTRADIOL	Proficient Rx LP	d19ff955-1778-43c7-a111-476d740dc9d9	2019-11-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200541 application number: ANDA200541 ndc (product): 63187-754

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-2429	TRI-LO-MARZIA	norgestimate and ethinyl estradiol	A-S Medication Solutions	ANDA	Current
57297-837	TRI-LO-MARZIA	norgestimate and ethinyl estradiol	LUPIN LIMITED	ANDA	Current
63187-754	TRI-LO-MARZIA	norgestimate and ethinyl estradiol	Proficient Rx LP	ANDA	Current
63187-754	TRI-LO-MARZIA	norgestimate and ethinyl estradiol	Proficient Rx LP	ANDA	Current
68180-837	TRI-LO-MARZIA	norgestimate and ethinyl estradiol	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-837	TRI-LO-MARZIA	norgestimate and ethinyl estradiol	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-837	TRI-LO-MARZIA	norgestimate and ethinyl estradiol	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-837	TRI-LO-MARZIA	norgestimate and ethinyl estradiol	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-837	TRI-LO-MARZIA	norgestimate and ethinyl estradiol	Lupin Pharmaceuticals, Inc.	ANDA	Current