Application 017060

Type: NDA
Sponsor: TEVA BRANDED PHARM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NOR-QD	NORETHINDRONE	TABLET;ORAL-28	0.35MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N017060-001	NOR-QD	NORETHINDRONE	0.35MG	TABLET / ORAL-28	AB1	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N017060-001	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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N017060-001	NOR-QD	0.35MG	TABLET / ORAL-28	AB1	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N017060-001	NOR-QD	0.35MG	TABLET / ORAL-28	AB1	RLD, RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N017060-001	NOR-QD	0.35MG	TABLET / ORAL-28	AB1	RLD, RS, Approved before 1982	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N017060-001	NOR-QD	0.35MG	TABLET / ORAL-28	AB1	RLD, RS, Approved before 1982	`a50c72e98297…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N017060-001	AB1	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N017060-001	AB1	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N017060-001	AB1	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N017060-001	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017060-001	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017060-001	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017060-001	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017060-001	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017060-001	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017060-001	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017060-001	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017060-001	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017060-001	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017060-001	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017060-001	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017060-001	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017060-001	AB1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017060-001	AB1	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N017060-001	AB1	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N017060-001	AB1	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N017060-001	AB1	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N017060-001	AB1	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N017060-001	AB1	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017060-001	AB1	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N017060-001	AB1	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N017060-001	AB1	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N017060-001	AB1	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N017060-001	AB1	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N017060-001	AB1	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N017060-001	AB1	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017060-001	AB1	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N017060-001	AB1	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N017060-001	AB1	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017060-001	AB1	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017060-001	AB1	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017060-001	AB1	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017060-001	AB1	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N017060-001	AB1	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N017060-001	AB1	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017060-001	AB1	1	`3a93d1ddd44b…`

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 · 21 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 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 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 generic name: NORETHINDRONE
NORETHINDRONE	NORETHINDRONE	A-S Medication Solutions	70231aa1-9dd2-420f-9cb3-432d3c2477d1	2025-02-18	Boxed warning, Warnings, Adverse reactions	Name fallback 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
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
Incassia	NORETHINDRONE	Aurobindo Pharma Limited	0b87cef0-610c-469d-92ba-4007f4bc3878	2021-09-14	Warnings, Adverse reactions	Name fallback generic name: NORETHINDRONE
Norethindrone	NORETHINDRONE	Proficient Rx LP	fb84b86e-5f1f-4c17-8b69-ff695c5faf55	2019-11-01	Warnings, Adverse reactions	Name fallback generic name: NORETHINDRONE

Reported adverse events (FAERS/openFDA)#

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

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
52544-629	Nora BE	Norethindrone	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
52544-629	Nora BE	Norethindrone	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
52544-629	Nora BE	Norethindrone	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
52544-629	Nora BE	Norethindrone	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
52544-629	Nora BE	Norethindrone	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
538	SUPPL	2005-10-25