Application 078666

Type: ANDA
Sponsor: WATSON LABS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LEVONORGESTREL	LEVONORGESTREL	TABLET;ORAL	0.75MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A078666-001	LEVONORGESTREL	LEVONORGESTREL	0.75MG	TABLET / ORAL			2009-06-24

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A078666-001	LEVONORGESTREL	0.75MG	TABLET / ORAL	2009-06-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078666-001	LEVONORGESTREL	0.75MG	TABLET / ORAL	2009-06-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078666-001	LEVONORGESTREL	0.75MG	TABLET / ORAL	2009-06-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078666-001	LEVONORGESTREL	0.75MG	TABLET / ORAL	2009-06-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078666-001	LEVONORGESTREL	0.75MG	TABLET / ORAL	2009-06-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078666-001	LEVONORGESTREL	0.75MG	TABLET / ORAL	2009-06-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078666-001	LEVONORGESTREL	0.75MG	TABLET / ORAL	2009-06-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078666-001	LEVONORGESTREL	0.75MG	TABLET / ORAL	2009-06-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078666-001	LEVONORGESTREL	0.75MG	TABLET / ORAL	2009-06-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078666-001	LEVONORGESTREL	0.75MG	TABLET / ORAL	2009-06-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078666-001	LEVONORGESTREL	0.75MG	TABLET / ORAL	2009-06-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078666-001	LEVONORGESTREL	0.75MG	TABLET / ORAL	2009-06-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078666-001	LEVONORGESTREL	0.75MG	TABLET / ORAL	2009-06-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078666-001	LEVONORGESTREL	0.75MG	TABLET / ORAL	2009-06-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078666-001	LEVONORGESTREL	0.75MG	TABLET / ORAL	2009-06-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078666-001	LEVONORGESTREL	0.75MG	TABLET / ORAL	2009-06-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078666-001	LEVONORGESTREL	0.75MG	TABLET / ORAL	2009-06-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078666-001	LEVONORGESTREL	0.75MG	TABLET / ORAL	2009-06-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078666-001	LEVONORGESTREL	0.75MG	TABLET / ORAL	2009-06-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078666-001	LEVONORGESTREL	0.75MG	TABLET / ORAL	2009-06-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078666-001	LEVONORGESTREL	0.75MG	TABLET / ORAL	2009-06-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078666-001	LEVONORGESTREL	0.75MG	TABLET / ORAL	2009-06-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078666-001	LEVONORGESTREL	0.75MG	TABLET / ORAL	2009-06-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078666-001	LEVONORGESTREL	0.75MG	TABLET / ORAL	2009-06-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078666-001	LEVONORGESTREL	0.75MG	TABLET / ORAL	2009-06-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078666-001	LEVONORGESTREL	0.75MG	TABLET / ORAL	2009-06-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078666-001	LEVONORGESTREL	0.75MG	TABLET / ORAL	2009-06-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078666-001	LEVONORGESTREL	0.75MG	TABLET / ORAL	2009-06-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078666-001	LEVONORGESTREL	0.75MG	TABLET / ORAL	2009-06-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078666-001	LEVONORGESTREL	0.75MG	TABLET / ORAL	2009-06-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078666-001	LEVONORGESTREL	0.75MG	TABLET / ORAL	2009-06-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078666-001	LEVONORGESTREL	0.75MG	TABLET / ORAL	2009-06-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078666-001	LEVONORGESTREL	0.75MG	TABLET / ORAL	2009-06-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078666-001	LEVONORGESTREL	0.75MG	TABLET / ORAL	2009-06-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078666-001	LEVONORGESTREL	0.75MG	TABLET / ORAL	2009-06-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078666-001	LEVONORGESTREL	0.75MG	TABLET / ORAL	2009-06-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078666-001	LEVONORGESTREL	0.75MG	TABLET / ORAL	2009-06-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078666-001	LEVONORGESTREL	0.75MG	TABLET / ORAL	2009-06-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078666-001	LEVONORGESTREL	0.75MG	TABLET / ORAL	2009-06-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078666-001	LEVONORGESTREL	0.75MG	TABLET / ORAL	2009-06-24	`f41ea6bd6efb…`

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 3 · 57 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LEVONORGESTREL	LEVONORGESTREL	YYBA CORP	5a71b870-9a0a-7997-e063-6294a90a882c	2026-09-01	Warnings	Name fallback brand name: LEVONORGESTREL generic name: LEVONORGESTREL
SheWise	LEVONORGESTREL	GLENMARK THERAPEUTICS INC., USA	7be13a7e-b4ff-4fe1-82a6-f9914596d72a	2026-07-15	Warnings	Name fallback generic name: LEVONORGESTREL
Levonorgestrel	LEVONORGESTREL	GLENMARK THERAPEUTICS INC., USA	07567b80-d8a1-41c0-95e4-33afa584bbc4	2026-07-15	Warnings	Name fallback brand name: Levonorgestrel generic name: LEVONORGESTREL
OPTION 2	LEVONORGESTREL	L. Perrigo Company	7d7b9e61-9f3d-477d-b74d-b0cc725f9bba	2026-06-25	Warnings	Name fallback generic name: LEVONORGESTREL
Levonorgestrel	LEVONORGESTREL	Rugby Laboratories	076126e4-9d76-45cd-a86b-5b35c56b620a	2026-05-13	Warnings	Name fallback brand name: Levonorgestrel generic name: LEVONORGESTREL
LEADER Emergency Contraceptive Levonorgestrel	LEVONORGESTREL	Cardinal Health 110, LLC. DBA Leader	d1e33615-0a98-4223-833d-843c758d9db7	2026-05-06	Warnings	Name fallback generic name: LEVONORGESTREL
My Choice	LEVONORGESTREL	OHM LABORATORIES INC	500d9418-69a8-f4f3-e063-6394a90a9b66	2026-04-22	Warnings	Name fallback generic name: LEVONORGESTREL
LEVONORGESTREL	LEVONORGESTREL	Camber Consumer Care Inc	2e22d0c4-b308-4a02-b2b0-2c06fb91d1e5	2026-03-23	Warnings	Name fallback brand name: LEVONORGESTREL generic name: LEVONORGESTREL
Skyla	LEVONORGESTREL	Bayer HealthCare Pharmaceuticals Inc.	9f44ff35-e052-49cd-a1c2-0bfd87d49309	2026-03-04	Warnings, Adverse reactions	Name fallback generic name: LEVONORGESTREL
Restart	LEVONORGESTREL	Winx Health Inc.	0cdf198e-c114-b9fa-e063-6294a90a566a	2026-02-24	Warnings	Name fallback generic name: LEVONORGESTREL
Levonorgestrel	LEVONORGESTREL	YYBA Corp	49008f10-8a70-3c08-e063-6294a90a44a3	2026-02-03	Warnings	Name fallback brand name: Levonorgestrel generic name: LEVONORGESTREL
Her Style	LEVONORGESTREL	Ingenus Pharmaceuticals, LLC	6e631755-b7c5-4a3a-b46d-f66b4ceedb1c	2025-12-05	Warnings	Name fallback generic name: LEVONORGESTREL
New Day	LEVONORGESTREL	Northstar Rx LLC	9e8c96f6-ab51-4721-b276-1ca02a712510	2025-12-05	Warnings	Name fallback generic name: LEVONORGESTREL
My Way	LEVONORGESTREL	Lupin Pharmaceuticals, Inc.	3efec61d-e0a6-49c5-9b88-834db6d171fd	2025-12-02	Warnings	Name fallback generic name: LEVONORGESTREL
Julie Morning After Pill	LEVONORGESTREL	Julie Products Inc.	40bb96f0-d5f1-1ec3-e063-6294a90a74b1	2025-11-26	Warnings	Name fallback generic name: LEVONORGESTREL
Julie Morning After Pill	LEVONORGESTREL	Julie Products Inc.	40bbad6f-0c54-e4ed-e063-6394a90af3ad	2025-11-14	Warnings	Name fallback generic name: LEVONORGESTREL
Mirena	LEVONORGESTREL	Bayer HealthCare Pharmaceuticals Inc.	dcbd6aa2-b3fa-479a-a676-56ea742962fc	2025-10-29	Warnings, Adverse reactions	Name fallback generic name: LEVONORGESTREL
Kyleena	LEVONORGESTREL	Bayer HealthCare Pharmaceuticals Inc.	2e07c155-21e1-4781-9633-ce8bddd47080	2025-10-23	Warnings, Adverse reactions	Name fallback generic name: LEVONORGESTREL
Julie	LEVONORGESTREL	Julie Products Inc	2e9784da-2186-a630-e063-6294a90a8493	2025-07-14	Warnings	Name fallback generic name: LEVONORGESTREL
Levonorgestrel	LEVONORGESTREL	Ohm Laboratories Inc.	f3f2a41a-a9af-4d63-81d8-33181d12af40	2025-07-04	Warnings	Name fallback brand name: Levonorgestrel generic name: LEVONORGESTREL

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
21695-443	NEXT CHOICE	Levonorgestrel	Rebel Distributors Corp.	ANDA	Current