Application 076225

Type: ANDA
Sponsor: MAYNE PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ERRIN	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
A076225-001	ERRIN	NORETHINDRONE	0.35MG	TABLET / ORAL-28	AB2		2002-10-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076225-001	AB2

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	A076225-001	ERRIN	0.35MG	TABLET / ORAL-28	AB2	2002-10-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076225-001	ERRIN	0.35MG	TABLET / ORAL-28	AB2	2002-10-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076225-001	ERRIN	0.35MG	TABLET / ORAL-28	AB2	2002-10-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076225-001	ERRIN	0.35MG	TABLET / ORAL-28	AB2	2002-10-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076225-001	ERRIN	0.35MG	TABLET / ORAL-28	AB2	2002-10-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076225-001	ERRIN	0.35MG	TABLET / ORAL-28	AB2	2002-10-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076225-001	ERRIN	0.35MG	TABLET / ORAL-28	AB2	2002-10-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076225-001	ERRIN	0.35MG	TABLET / ORAL-28	AB2	2002-10-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076225-001	ERRIN	0.35MG	TABLET / ORAL-28	AB2	2002-10-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076225-001	ERRIN	0.35MG	TABLET / ORAL-28	AB2	2002-10-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076225-001	ERRIN	0.35MG	TABLET / ORAL-28	AB2	2002-10-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076225-001	ERRIN	0.35MG	TABLET / ORAL-28	AB2	2002-10-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076225-001	ERRIN	0.35MG	TABLET / ORAL-28	AB2	2002-10-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076225-001	ERRIN	0.35MG	TABLET / ORAL-28	AB2	2002-10-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076225-001	ERRIN	0.35MG	TABLET / ORAL-28	AB2	2002-10-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076225-001	ERRIN	0.35MG	TABLET / ORAL-28	AB2	2002-10-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076225-001	ERRIN	0.35MG	TABLET / ORAL-28	AB2	2002-10-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076225-001	ERRIN	0.35MG	TABLET / ORAL-28	AB2	2002-10-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076225-001	ERRIN	0.35MG	TABLET / ORAL-28	AB2	2002-10-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076225-001	ERRIN	0.35MG	TABLET / ORAL-28	AB2	2002-10-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076225-001	ERRIN	0.35MG	TABLET / ORAL-28	AB2	2002-10-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076225-001	ERRIN	0.35MG	TABLET / ORAL-28	AB2	2002-10-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076225-001	ERRIN	0.35MG	TABLET / ORAL-28	AB2	2002-10-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076225-001	ERRIN	0.35MG	TABLET / ORAL-28	AB2	2002-10-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076225-001	ERRIN	0.35MG	TABLET / ORAL-28	AB2	2002-10-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076225-001	ERRIN	0.35MG	TABLET / ORAL-28	AB2	2002-10-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076225-001	ERRIN	0.35MG	TABLET / ORAL-28	AB2	2002-10-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076225-001	ERRIN	0.35MG	TABLET / ORAL-28	AB2	2002-10-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076225-001	ERRIN	0.35MG	TABLET / ORAL-28	AB2	2002-10-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076225-001	ERRIN	0.35MG	TABLET / ORAL-28	AB2	2002-10-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076225-001	ERRIN	0.35MG	TABLET / ORAL-28	AB2	2002-10-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076225-001	ERRIN	0.35MG	TABLET / ORAL-28	AB2	2002-10-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076225-001	ERRIN	0.35MG	TABLET / ORAL-28	AB2	2002-10-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076225-001	ERRIN	0.35MG	TABLET / ORAL-28	AB2	2002-10-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076225-001	ERRIN	0.35MG	TABLET / ORAL-28	AB2	2002-10-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076225-001	ERRIN	0.35MG	TABLET / ORAL-28	AB2	2002-10-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076225-001	ERRIN	0.35MG	TABLET / ORAL-28	AB2	2002-10-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076225-001	ERRIN	0.35MG	TABLET / ORAL-28	AB2	2002-10-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076225-001	ERRIN	0.35MG	TABLET / ORAL-28	AB2	2002-10-21	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076225-001	ERRIN	0.35MG	TABLET / ORAL-28	AB2	2002-10-21	`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	A076225-001	AB2	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076225-001	AB2	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076225-001	AB2	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076225-001	AB2	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076225-001	AB2	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076225-001	AB2	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076225-001	AB2	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076225-001	AB2	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076225-001	AB2	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076225-001	AB2	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076225-001	AB2	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076225-001	AB2	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076225-001	AB2	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076225-001	AB2	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076225-001	AB2	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076225-001	AB2	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076225-001	AB2	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076225-001	AB2	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076225-001	AB2	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076225-001	AB2	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076225-001	AB2	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076225-001	AB2	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076225-001	AB2	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076225-001	AB2	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076225-001	AB2	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076225-001	AB2	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076225-001	AB2	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076225-001	AB2	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076225-001	AB2	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076225-001	AB2	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076225-001	AB2	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076225-001	AB2	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076225-001	AB2	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076225-001	AB2	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076225-001	AB2	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076225-001	AB2	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076225-001	AB2	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076225-001	AB2	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076225-001	AB2	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076225-001	AB2	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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ERRIN	NORETHINDRONE	Dr. Reddy's Labratories Inc.	df29577b-c2f0-bea8-b048-7719972707aa	2024-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076225 application number: ANDA076225
ERRIN	NORETHINDRONE	Proficient Rx LP	904899f2-9c54-44d2-901e-47e894571500	2024-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076225 application number: ANDA076225 ndc (product): 71205-526
ERRIN	NORETHINDRONE	Mayne Pharma Inc.	32e6366a-8bb4-4b67-b4a3-e372c7696fa7	2022-03-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076225 application number: ANDA076225 ndc (product): 51862-886

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
0555-0344	Errin	Norethindrone	Teva Pharmaceuticals USA,	ANDA	Current
51862-100	Errin	Norethindrone	Mayne Pharma Inc.	ANDA	Current
51862-886	ERRIN	NORETHINDRONE	Mayne Pharma Inc.	ANDA	Current
51862-886	ERRIN	NORETHINDRONE	Mayne Pharma Inc.	ANDA	Current
71205-526	ERRIN	NORETHINDRONE	Proficient Rx LP	ANDA	Current