Application 202260

Type: ANDA
Sponsor: AMNEAL PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NORETHINDRONE	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
A202260-001	NORETHINDRONE	NORETHINDRONE	0.35MG	TABLET / ORAL-28			2013-08-01

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	A202260-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28		2013-08-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202260-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28		2013-08-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202260-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28		2013-08-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202260-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28		2013-08-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202260-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28		2013-08-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202260-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28		2013-08-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202260-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28		2013-08-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202260-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28		2013-08-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202260-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28		2013-08-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202260-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28		2013-08-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202260-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28		2013-08-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202260-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28		2013-08-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202260-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28		2013-08-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202260-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28		2013-08-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202260-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28	AB1	2013-08-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202260-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28	AB1	2013-08-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202260-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28	AB1	2013-08-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202260-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28	AB1	2013-08-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202260-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28	AB1	2013-08-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202260-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28	AB1	2013-08-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202260-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28	AB1	2013-08-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202260-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28	AB1	2013-08-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202260-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28	AB1	2013-08-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202260-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28	AB1	2013-08-01	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202260-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28	AB1	2013-08-01	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202260-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28	AB1	2013-08-01	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202260-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28	AB1	2013-08-01	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202260-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28		2013-08-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202260-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28		2013-08-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202260-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28		2013-08-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202260-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28		2013-08-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202260-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28		2013-08-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202260-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28		2013-08-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202260-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28		2013-08-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202260-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28		2013-08-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202260-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28		2013-08-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202260-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28		2013-08-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202260-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28		2013-08-01	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202260-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28	AB1	2013-08-01	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202260-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28	AB1	2013-08-01	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202260-001	AB1	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202260-001	AB1	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202260-001	AB1	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202260-001	AB1	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202260-001	AB1	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202260-001	AB1	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202260-001	AB1	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202260-001	AB1	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202260-001	AB1	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202260-001	AB1	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202260-001	AB1	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202260-001	AB1	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202260-001	AB1	1	`ea99ee380514…`
2022-09-29 23:25 UTC	2022-09	A202260-001	AB1	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202260-001	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 2 · 24 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Norethindrone	NORETHINDRONE	Glenmark Pharmaceuticals Inc., USA	0d2f8fea-3675-40d2-afd9-9fcb148dbd4b	2026-01-31	Warnings, Adverse reactions	Name fallback brand name: Norethindrone generic name: NORETHINDRONE
HEATHER	NORETHINDRONE	Glenmark Pharmaceuticals Inc., USA	35b5ddb5-1729-4588-b2a2-ead56d78b6f9	2026-01-23	Warnings, Adverse reactions	Name fallback generic name: NORETHINDRONE
NORETHINDRONE	NORETHINDRONE	Proficient Rx LP	bbd54f1e-2d48-4efa-a57e-7fa7b478c457	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: NORETHINDRONE generic name: NORETHINDRONE
Jencycla	NORETHINDRONE	Lupin Pharmaceuticals, Inc.	e91e7bdd-2984-4332-9b0b-04322792d7f6	2025-12-08	Warnings, Adverse reactions	Name fallback generic name: NORETHINDRONE
DEBLITANE	NORETHINDRONE	Northstar Rx LLC	e75367ff-78af-4bd2-a99d-d291cb1d21eb	2025-12-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NORETHINDRONE
SHAROBEL	NORETHINDRONE	Northstar Rx LLC	a96f5194-ad2a-4783-a9a9-22a288caff25	2025-12-05	Warnings, Adverse reactions	Name fallback generic name: NORETHINDRONE
Norethindrone Acetate	NORETHINDRONE	AvKARE	827c7ef1-a8b7-d0c4-b062-c5154b331a35	2025-09-17	Warnings, Adverse reactions	Name fallback generic name: NORETHINDRONE
MELEYA	NORETHINDRONE	Xiromed LLC	534c5717-382c-4109-3208-e21b32e4c4c9	2025-03-06	Warnings, Adverse reactions	Name fallback generic name: NORETHINDRONE
NORETHINDRONE	NORETHINDRONE	Lupin Pharmaceuticals, Inc.	121fbf86-1d76-4579-be2f-be9a957b23ab	2025-02-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: NORETHINDRONE generic name: NORETHINDRONE
NORETHINDRONE	NORETHINDRONE	A-S Medication Solutions	70231aa1-9dd2-420f-9cb3-432d3c2477d1	2025-02-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: NORETHINDRONE generic name: NORETHINDRONE
Orquidea	NORETHINDRONE	Xiromed, LLC	6e9f61a1-93ff-291a-bea8-9307a3b0378e	2025-01-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NORETHINDRONE
Norethindrone Acetate	NORETHINDRONE	Amneal Pharmaceuticals LLC	64cb920c-36e8-4d62-9d08-3ddf3989d313	2024-10-30	Warnings, Adverse reactions	Name fallback generic name: NORETHINDRONE
Affodel	NORETHINDRONE	Naari Pte. Limited	8ec64ec8-fbc9-440d-9838-654a605d57da	2024-04-22	Warnings, Adverse reactions	Name fallback generic name: NORETHINDRONE
Nora BE	NORETHINDRONE	Teva Pharmaceuticals, Inc.	426ac898-7745-4645-bf9b-bae319e260e8	2024-04-02	Warnings, Adverse reactions	Name fallback generic name: NORETHINDRONE
CAMILA	NORETHINDRONE	Dr. Reddy's Labratories Inc.	59985565-af09-21ba-0336-3f6db7711bd1	2024-04-01	Warnings, Adverse reactions	Name fallback generic name: NORETHINDRONE
ERRIN	NORETHINDRONE	Dr. Reddy's Labratories Inc.	df29577b-c2f0-bea8-b048-7719972707aa	2024-03-01	Warnings, Adverse reactions	Name fallback generic name: NORETHINDRONE
ERRIN	NORETHINDRONE	Proficient Rx LP	904899f2-9c54-44d2-901e-47e894571500	2024-01-01	Warnings, Adverse reactions	Name fallback generic name: NORETHINDRONE
Emzahh	NORETHINDRONE	Aurobindo Pharma Limited	197d31d3-eec8-49c7-9640-918ff138fea2	2023-04-10	Warnings, Adverse reactions	Name fallback generic name: NORETHINDRONE
Lyleq	NORETHINDRONE	Afaxys Pharma, LLC	c9f00a3e-c827-4066-bf85-079b3a20f25e	2023-03-27	Warnings, Adverse reactions	Name fallback generic name: NORETHINDRONE
ERRIN	NORETHINDRONE	Mayne Pharma Inc.	32e6366a-8bb4-4b67-b4a3-e372c7696fa7	2022-03-29	Warnings, Adverse reactions	Name fallback generic name: NORETHINDRONE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-3235	Norlyda	norethindrone	A-S Medication Solutions	ANDA	Current
50090-3235	Norlyda	norethindrone	A-S Medication Solutions	ANDA	Current
51660-127	NORLYROC	norethindrone	Ohm Laboratories Inc.	ANDA	Current
69238-1583	Norlyda	norethindrone	Amneal Pharmaceuticals LLC	ANDA	Current
69238-1583	Norlyda	norethindrone	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1583	Norlyda	norethindrone	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1583	Norlyda	norethindrone	Amneal Pharmaceuticals NY LLC	ANDA	Current