Application 202380

Type: ANDA
Sponsor: NAARI PTE 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
A202380-001	LEVONORGESTREL	LEVONORGESTREL	1.5MG	TABLET / ORAL			2015-05-29

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	A202380-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2015-05-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202380-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2015-05-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202380-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2015-05-29	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A202380-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2015-05-29	`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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Morning After Pill	LEVONORGESTREL	Cadence Health Inc	fc5d29bb-4a4b-e61e-e053-6394a90a8a62	2025-02-14	Warnings	Exact identifier application applno (ANDA): 202380 application number: ANDA202380
Optionelle	LEVONORGESTREL TABLET, 1.5 MG	Strides Pharma Inc	1c7e849c-6392-48a6-9214-907325a012e2	2022-09-16	Warnings	Exact identifier application applno (ANDA): 202380 application number: ANDA202380 ndc (product): 59556-286
Levonorgestrel Tablet, 1.5 mg	LEVONORGESTREL TABLET, 1.5 MG	Strides Pharma Inc	98f6367e-14d2-4c7a-9418-d996f0040d22	2022-09-13	Warnings	Exact identifier application applno (ANDA): 202380 application number: ANDA202380 ndc (product): 59556-282

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 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
49615-017	Levonorgestrel	Levonorgestrel	OC Pharma, LLC	ANDA	Current
59556-282	Levonorgestrel Tablet, 1.5 mg	Levonorgestrel Tablet, 1.5 mg	Strides Pharma Inc	ANDA	Current
59556-286	Optionelle	Levonorgestrel Tablet, 1.5 mg	Strides Pharma Inc	ANDA	Current
73358-911	Levonorgestrel	Levonorgestrel	Curae Pharma360 Inc.	ANDA	Current
82791-332	Julie	Levonorgestrel	Julie Products, Inc	ANDA	Current