Application 202508

Type: ANDA
Sponsor: NOVEL LABS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LEVONORGESTREL	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
A202508-001	LEVONORGESTREL	LEVONORGESTREL	1.5MG	TABLET / ORAL			2013-02-22

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	A202508-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2013-02-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202508-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2013-02-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202508-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2013-02-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202508-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2013-02-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202508-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2013-02-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202508-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2013-02-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202508-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2013-02-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202508-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2013-02-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202508-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2013-02-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202508-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2013-02-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202508-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2013-02-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202508-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2013-02-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202508-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2013-02-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202508-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2013-02-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202508-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2013-02-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202508-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2013-02-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202508-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2013-02-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202508-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2013-02-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202508-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2013-02-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202508-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2013-02-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202508-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2013-02-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202508-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2013-02-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202508-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2013-02-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202508-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2013-02-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202508-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2013-02-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202508-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2013-02-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202508-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2013-02-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202508-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2013-02-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202508-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2013-02-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202508-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2013-02-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202508-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2013-02-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202508-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2013-02-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202508-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2013-02-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202508-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2013-02-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202508-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2013-02-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202508-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2013-02-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202508-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2013-02-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202508-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2013-02-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202508-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2013-02-22	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202508-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2013-02-22	`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
Levonorgestrel	LEVONORGESTREL	Novel Laboratories, Inc.	ac13a073-a33a-45f7-8483-eecc9190195f	2017-09-15		Exact identifier application applno (ANDA): 202508 application number: ANDA202508 ndc (product): 40032-622
My Way	LEVONORGESTREL	Lupin Pharmaceuticals,Inc.	ec01077e-ac3c-424a-9edc-0854fe0a2e0d	2016-06-17	Warnings	Exact identifier application applno (ANDA): 202508 application number: ANDA202508 ndc (product): 43386-622

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
40032-620	Levonorgestrel	Levonorgestrel	Novel Laboratories, Inc.	ANDA	Current
40032-622	Levonorgestrel	Levonorgestrel	Novel Laboratories, Inc.	ANDA	Current
43386-620	My Way	Levonorgestrel	GAVIS Pharmaceuticals, LLC.	ANDA	Current
43386-622	My Way	Levonorgestrel	Lupin Pharmaceuticals,Inc.	ANDA	Current
63704-009	Levonorgestrel	Levonorgestrel	Pharmacist Pharmaceutical, LLC	ANDA	Current
63704-010	Levonorgestrel	Levonorgestrel	Pharmacist Pharmaceutical, LLC	ANDA	Current