Application 202246

Type: ANDA
Sponsor: ALVOGEN

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 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
A202246-001	LEVONORGESTREL	LEVONORGESTREL	1.5MG	TABLET / ORAL			2015-06-05

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	A202246-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2015-06-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202246-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2015-06-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202246-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2015-06-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202246-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2015-06-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202246-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2015-06-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202246-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2015-06-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202246-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2015-06-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202246-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2015-06-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202246-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2015-06-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202246-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2015-06-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202246-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2015-06-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202246-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2015-06-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202246-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2015-06-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202246-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2015-06-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202246-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2015-06-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202246-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2015-06-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202246-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2015-06-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202246-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2015-06-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202246-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2015-06-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202246-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2015-06-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202246-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2015-06-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202246-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2015-06-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202246-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2015-06-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202246-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2015-06-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202246-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2015-06-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202246-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2015-06-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202246-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2015-06-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202246-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2015-06-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202246-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2015-06-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202246-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2015-06-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202246-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2015-06-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202246-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2015-06-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202246-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2015-06-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202246-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2015-06-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202246-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2015-06-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202246-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2015-06-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202246-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2015-06-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202246-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2015-06-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202246-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2015-06-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202246-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2015-06-05	`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 3 of 3 · 56 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Levonorgestrel	LEVONORGESTREL	Xiromed LLC	626a2333-ff56-ef28-a287-b33bacc0302a	2023-09-05	Warnings	Name fallback brand name: Levonorgestrel generic name: LEVONORGESTREL
LILETTA	LEVONORGESTREL	Allergan, Inc.	aaf0eb2a-f88a-4f26-a445-0fd30176c326	2023-06-29	Warnings, Adverse reactions	Name fallback generic name: LEVONORGESTREL
Levonorgestrel	LEVONORGESTREL	Naari Pte Limited	be8b7ace-9af8-4417-85fa-863e19072887	2023-03-16	Warnings	Name fallback brand name: Levonorgestrel generic name: LEVONORGESTREL
Next Choice One Dose	LEVONORGESTREL	Foundation Consumer Healthcare LLC	504735bd-6af9-4588-bf85-d09dbf2a7e41	2023-02-02	Warnings	Name fallback generic name: LEVONORGESTREL
Take Action	LEVONORGESTREL	Foundation Consumer Healthcare LLC	78eee7c9-5ca5-45af-898f-92a2f3b2598e	2023-01-31	Warnings	Name fallback generic name: LEVONORGESTREL
Aftera	LEVONORGESTREL	Foundation Consumer Healthcare LLC	53ad8dff-9134-475c-90b3-8087753e17c4	2023-01-31	Warnings	Name fallback generic name: LEVONORGESTREL
Plan B One-Step	LEVONORGESTREL	Foundation Consumer Healthcare LLC	6ce6b40e-14ac-47bd-a648-ddf9e452e559	2023-01-31	Warnings	Name fallback generic name: LEVONORGESTREL
Opcicon One-Step	LEVONORGESTREL	Sun Pharmaceutical Industries, Inc.	b67ca313-561e-471f-baf3-257b7e253c75	2023-01-13	Warnings	Name fallback generic name: LEVONORGESTREL
Morning After	LEVONORGESTREL	Rapha Pharmaceuticals, Inc.	f0fab784-3d28-35fb-e053-2995a90ab611	2022-12-29	Warnings	Name fallback generic name: LEVONORGESTREL
My Choice TM	LEVONORGESTREL	Proficient Rx LP	165f7270-d050-4e97-b30f-107b96940d84	2022-09-01	Warnings	Name fallback generic name: LEVONORGESTREL
My Choice TM	LEVONORGESTREL	SUN PHARMACEUTICAL INDUSTRIES, INC.	66753300-fb61-4f09-af74-ee498b0bd595	2022-04-21	Warnings	Name fallback generic name: LEVONORGESTREL
Option 2	LEVONORGESTREL	L. Perrigo Company	9b9e9352-3e4d-4ec3-96aa-8fd58d82fe96	2020-07-30	Warnings	Name fallback generic name: LEVONORGESTREL
AfterPlan	LEVONORGESTREL	SUN PHARMACEUTICAL INDUSTRIES, INC.	c30c7bc2-04fa-4590-96f5-5bcf4bba3f1a	2018-10-26	Warnings	Name fallback generic name: LEVONORGESTREL
Morning After	LEVONORGESTREL	Rapha Pharmaceuticals, Inc.	677aa953-3c30-4ce5-e053-2991aa0ab2b2	2018-03-15	Warnings	Name fallback generic name: LEVONORGESTREL
Levonorgestrel	LEVONORGESTREL	Novel Laboratories, Inc.	ac13a073-a33a-45f7-8483-eecc9190195f	2017-09-15		Name fallback brand name: Levonorgestrel generic name: LEVONORGESTREL
My Way	LEVONORGESTREL	Lupin Pharmaceuticals,Inc.	ec01077e-ac3c-424a-9edc-0854fe0a2e0d	2016-06-17	Warnings	Name fallback generic name: LEVONORGESTREL

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 · 1 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
64679-050	React	Levonorgestrel	Wockhardt USA, LLC	ANDA	Current