Application 207976

Type: ANDA
Sponsor: NOVAST LABS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HER STYLE	LEVONORGESTREL	TABLET;ORAL	1.5MG	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
A207976-001	HER STYLE	LEVONORGESTREL	1.5MG	TABLET / ORAL			2016-03-11

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A207976-001	HER STYLE	1.5MG	TABLET / ORAL	2016-03-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207976-001	HER STYLE	1.5MG	TABLET / ORAL	2016-03-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207976-001	HER STYLE	1.5MG	TABLET / ORAL	2016-03-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207976-001	HER STYLE	1.5MG	TABLET / ORAL	2016-03-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207976-001	HER STYLE	1.5MG	TABLET / ORAL	2016-03-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207976-001	HER STYLE	1.5MG	TABLET / ORAL	2016-03-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207976-001	HER STYLE	1.5MG	TABLET / ORAL	2016-03-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207976-001	HER STYLE	1.5MG	TABLET / ORAL	2016-03-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207976-001	HER STYLE	1.5MG	TABLET / ORAL	2016-03-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207976-001	HER STYLE	1.5MG	TABLET / ORAL	2016-03-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207976-001	HER STYLE	1.5MG	TABLET / ORAL	2016-03-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207976-001	HER STYLE	1.5MG	TABLET / ORAL	2016-03-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207976-001	HER STYLE	1.5MG	TABLET / ORAL	2016-03-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207976-001	HER STYLE	1.5MG	TABLET / ORAL	2016-03-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207976-001	HER STYLE	1.5MG	TABLET / ORAL	2016-03-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207976-001	HER STYLE	1.5MG	TABLET / ORAL	2016-03-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207976-001	HER STYLE	1.5MG	TABLET / ORAL	2016-03-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207976-001	HER STYLE	1.5MG	TABLET / ORAL	2016-03-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207976-001	HER STYLE	1.5MG	TABLET / ORAL	2016-03-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207976-001	HER STYLE	1.5MG	TABLET / ORAL	2016-03-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207976-001	HER STYLE	1.5MG	TABLET / ORAL	2016-03-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207976-001	HER STYLE	1.5MG	TABLET / ORAL	2016-03-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207976-001	HER STYLE	1.5MG	TABLET / ORAL	2016-03-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207976-001	HER STYLE	1.5MG	TABLET / ORAL	2016-03-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207976-001	HER STYLE	1.5MG	TABLET / ORAL	2016-03-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207976-001	HER STYLE	1.5MG	TABLET / ORAL	2016-03-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207976-001	HER STYLE	1.5MG	TABLET / ORAL	2016-03-11	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207976-001	HER STYLE	1.5MG	TABLET / ORAL	2016-03-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207976-001	HER STYLE	1.5MG	TABLET / ORAL	2016-03-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207976-001	HER STYLE	1.5MG	TABLET / ORAL	2016-03-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207976-001	HER STYLE	1.5MG	TABLET / ORAL	2016-03-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207976-001	HER STYLE	1.5MG	TABLET / ORAL	2016-03-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207976-001	HER STYLE	1.5MG	TABLET / ORAL	2016-03-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207976-001	HER STYLE	1.5MG	TABLET / ORAL	2016-03-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207976-001	HER STYLE	1.5MG	TABLET / ORAL	2016-03-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207976-001	HER STYLE	1.5MG	TABLET / ORAL	2016-03-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207976-001	HER STYLE	1.5MG	TABLET / ORAL	2016-03-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207976-001	HER STYLE	1.5MG	TABLET / ORAL	2016-03-11	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207976-001	HER STYLE	1.5MG	TABLET / ORAL	2016-03-11	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207976-001	HER STYLE	1.5MG	TABLET / ORAL	2016-03-11	`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
Her Style	LEVONORGESTREL	Ingenus Pharmaceuticals, LLC	6e631755-b7c5-4a3a-b46d-f66b4ceedb1c	2025-12-05	Warnings	Exact identifier application applno (ANDA): 207976 application number: ANDA207976 ndc (product): 50742-352
New Day	LEVONORGESTREL	Northstar Rx LLC	9e8c96f6-ab51-4721-b276-1ca02a712510	2025-12-05	Warnings	Exact identifier application applno (ANDA): 207976 application number: ANDA207976 ndc (product): 16714-809

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16714-809	New Day	levonorgestrel	Northstar Rx LLC	ANDA	Current
50742-352	Her Style	levonorgestrel	Ingenus Pharmaceuticals, LLC	ANDA	Current
50742-352	Her Style	levonorgestrel	Ingenus Pharmaceuticals, LLC	ANDA	Current
76413-357	New Day	levonorgestrel	Central Texas Community Health Centers	ANDA	Current