Application 207044

Type: ANDA
Sponsor: GLENMARK PHARMS LTD

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 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
A207044-001	LEVONORGESTREL	LEVONORGESTREL	1.5MG	TABLET / ORAL			2016-03-25

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	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	A207044-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2016-03-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207044-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2016-03-25	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207044-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2016-03-25	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A207044-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2016-03-25	`a50c72e98297…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SheWise	LEVONORGESTREL	GLENMARK THERAPEUTICS INC., USA	7be13a7e-b4ff-4fe1-82a6-f9914596d72a	2026-07-15	Warnings	Exact identifier application applno (ANDA): 207044 application number: ANDA207044 ndc (product): 72657-108
Levonorgestrel	LEVONORGESTREL	GLENMARK THERAPEUTICS INC., USA	07567b80-d8a1-41c0-95e4-33afa584bbc4	2026-07-15	Warnings	Exact identifier application applno (ANDA): 207044 application number: ANDA207044
Levonorgestrel	LEVONORGESTREL	YYBA Corp	49008f10-8a70-3c08-e063-6294a90a44a3	2026-02-03	Warnings	Exact identifier application applno (ANDA): 207044 application number: ANDA207044
PostDay One-Step	LEVONORGESTREL	Home Health Brands, LLC	01c8c95c-6fbe-4068-915d-74418a6bb570	2025-04-23	Warnings	Exact identifier application applno (ANDA): 207044 application number: ANDA207044

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 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68462-123	Levonorgestrel	Levonorgestrel	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
69452-243	BionaFem	Levonorgestrel	Bionpharma Inc.	ANDA	Current
72657-108	SheWise	Levonorgestrel	GLENMARK THERAPEUTICS INC., USA	ANDA	Current
72657-108	SheWise	Levonorgestrel	GLENMARK THERAPEUTICS INC., USA	ANDA	Current