Application 207304

Type: ANDA
Sponsor: AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	INCASSIA	NORETHINDRONE	TABLET;ORAL-28	0.35MG	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
A207304-001	INCASSIA	NORETHINDRONE	0.35MG	TABLET / ORAL-28	AB1		2016-09-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207304-001	AB1

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	A207304-001	INCASSIA	0.35MG	TABLET / ORAL-28	AB1	2016-09-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207304-001	INCASSIA	0.35MG	TABLET / ORAL-28	AB1	2016-09-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207304-001	INCASSIA	0.35MG	TABLET / ORAL-28	AB1	2016-09-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207304-001	INCASSIA	0.35MG	TABLET / ORAL-28	AB1	2016-09-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207304-001	INCASSIA	0.35MG	TABLET / ORAL-28	AB1	2016-09-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207304-001	INCASSIA	0.35MG	TABLET / ORAL-28	AB1	2016-09-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207304-001	INCASSIA	0.35MG	TABLET / ORAL-28	AB1	2016-09-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207304-001	INCASSIA	0.35MG	TABLET / ORAL-28	AB1	2016-09-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207304-001	INCASSIA	0.35MG	TABLET / ORAL-28	AB1	2016-09-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207304-001	INCASSIA	0.35MG	TABLET / ORAL-28	AB1	2016-09-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207304-001	INCASSIA	0.35MG	TABLET / ORAL-28	AB1	2016-09-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207304-001	INCASSIA	0.35MG	TABLET / ORAL-28	AB1	2016-09-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207304-001	INCASSIA	0.35MG	TABLET / ORAL-28	AB1	2016-09-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207304-001	INCASSIA	0.35MG	TABLET / ORAL-28	AB1	2016-09-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207304-001	INCASSIA	0.35MG	TABLET / ORAL-28	AB1	2016-09-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207304-001	INCASSIA	0.35MG	TABLET / ORAL-28	AB1	2016-09-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207304-001	INCASSIA	0.35MG	TABLET / ORAL-28	AB1	2016-09-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207304-001	INCASSIA	0.35MG	TABLET / ORAL-28	AB1	2016-09-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207304-001	INCASSIA	0.35MG	TABLET / ORAL-28	AB1	2016-09-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207304-001	INCASSIA	0.35MG	TABLET / ORAL-28	AB1	2016-09-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207304-001	INCASSIA	0.35MG	TABLET / ORAL-28	AB1	2016-09-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207304-001	INCASSIA	0.35MG	TABLET / ORAL-28	AB1	2016-09-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207304-001	INCASSIA	0.35MG	TABLET / ORAL-28	AB1	2016-09-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207304-001	INCASSIA	0.35MG	TABLET / ORAL-28	AB1	2016-09-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207304-001	INCASSIA	0.35MG	TABLET / ORAL-28	AB1	2016-09-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207304-001	INCASSIA	0.35MG	TABLET / ORAL-28	AB1	2016-09-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207304-001	INCASSIA	0.35MG	TABLET / ORAL-28	AB1	2016-09-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207304-001	INCASSIA	0.35MG	TABLET / ORAL-28	AB1	2016-09-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207304-001	INCASSIA	0.35MG	TABLET / ORAL-28	AB1	2016-09-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207304-001	INCASSIA	0.35MG	TABLET / ORAL-28	AB1	2016-09-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207304-001	INCASSIA	0.35MG	TABLET / ORAL-28	AB1	2016-09-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207304-001	INCASSIA	0.35MG	TABLET / ORAL-28	AB1	2016-09-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207304-001	INCASSIA	0.35MG	TABLET / ORAL-28	AB1	2016-09-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207304-001	INCASSIA	0.35MG	TABLET / ORAL-28	AB1	2016-09-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207304-001	INCASSIA	0.35MG	TABLET / ORAL-28	AB1	2016-09-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207304-001	INCASSIA	0.35MG	TABLET / ORAL-28	AB1	2016-09-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207304-001	INCASSIA	0.35MG	TABLET / ORAL-28	AB1	2016-09-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207304-001	INCASSIA	0.35MG	TABLET / ORAL-28	AB1	2016-09-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207304-001	INCASSIA	0.35MG	TABLET / ORAL-28	AB1	2016-09-23	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207304-001	INCASSIA	0.35MG	TABLET / ORAL-28	AB1	2016-09-23	`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	A207304-001	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207304-001	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207304-001	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207304-001	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207304-001	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207304-001	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207304-001	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207304-001	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207304-001	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207304-001	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207304-001	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207304-001	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207304-001	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207304-001	AB1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207304-001	AB1	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207304-001	AB1	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207304-001	AB1	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207304-001	AB1	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207304-001	AB1	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207304-001	AB1	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207304-001	AB1	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207304-001	AB1	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207304-001	AB1	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207304-001	AB1	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207304-001	AB1	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207304-001	AB1	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207304-001	AB1	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207304-001	AB1	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207304-001	AB1	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207304-001	AB1	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207304-001	AB1	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207304-001	AB1	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207304-001	AB1	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207304-001	AB1	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207304-001	AB1	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207304-001	AB1	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207304-001	AB1	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207304-001	AB1	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207304-001	AB1	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207304-001	AB1	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lyleq	NORETHINDRONE	Afaxys Pharma, LLC	c9f00a3e-c827-4066-bf85-079b3a20f25e	2023-03-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207304 application number: ANDA207304 ndc (product): 50102-300
Incassia	NORETHINDRONE	Aurobindo Pharma Limited	0b87cef0-610c-469d-92ba-4007f4bc3878	2021-09-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207304 application number: ANDA207304 ndc (product): 65862-925

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
50102-200	Tulana	NORETHINDRONE	Afaxys Pharma, LLC	ANDA	Current
50102-200	Tulana	NORETHINDRONE	Afaxys Pharma, LLC	ANDA	Current
50102-200	Tulana	NORETHINDRONE	Afaxys Pharma, LLC	ANDA	Current
50102-200	Tulana	NORETHINDRONE	Afaxys Pharma, LLC	ANDA	Current
50102-300	Lyleq	NORETHINDRONE	Afaxys Pharma, LLC	ANDA	Current
50102-300	Lyleq	NORETHINDRONE	Afaxys Pharma, LLC	ANDA	Current
53002-1793	Lyleq	NORETHINDRONE	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-2687	Tulana	NORETHINDRONE	RPK Pharmaceuticals, Inc.	ANDA	Current
65862-925	Incassia	NORETHINDRONE	Aurobindo Pharma Limited	ANDA	Current
65862-925	Incassia	NORETHINDRONE	Aurobindo Pharma Limited	ANDA	Current
65862-925	Incassia	NORETHINDRONE	Aurobindo Pharma Limited	ANDA	Current
65862-925	Incassia	NORETHINDRONE	Aurobindo Pharma Limited	ANDA	Current
65862-925	Incassia	NORETHINDRONE	Aurobindo Pharma Limited	ANDA	Current
65862-925	Incassia	NORETHINDRONE	Aurobindo Pharma Limited	ANDA	Current
65862-925	Incassia	NORETHINDRONE	Aurobindo Pharma Limited	ANDA	Current