Application 201446

Type: ANDA
Sponsor: LUPIN LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FALLBACK SOLO	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
A201446-001	FALLBACK SOLO	LEVONORGESTREL	1.5MG	TABLET / ORAL			2014-06-19

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	A201446-001	FALLBACK SOLO	1.5MG	TABLET / ORAL	2014-06-19	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A201446-001	FALLBACK SOLO	1.5MG	TABLET / ORAL	2014-06-19	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A201446-001	FALLBACK SOLO	1.5MG	TABLET / ORAL	2014-06-19	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A201446-001	FALLBACK SOLO	1.5MG	TABLET / ORAL	2014-06-19	`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
My Way	LEVONORGESTREL	Lupin Pharmaceuticals, Inc.	3efec61d-e0a6-49c5-9b88-834db6d171fd	2025-12-02	Warnings	Exact identifier application applno (ANDA): 201446 application number: ANDA201446 ndc (product): 68180-852
AfterPill	LEVONORGESTREL	Syzygy Healthcare Solutions, LLC PO Box 588, Westport, CT 06880	4d284ba4-9cd7-48e4-95b9-cd6d0367bfd1	2025-05-01	Warnings	Exact identifier application applno (ANDA): 201446 application number: ANDA201446 ndc (product): 64122-605
My Way	LEVONORGESTREL	Proficient Rx LP	f2354b0c-dda4-4eb4-93f3-b2d57856a948	2025-01-01	Warnings	Exact identifier application applno (ANDA): 201446 application number: ANDA201446 ndc (product): 71205-361
My Way	LEVONORGESTREL	NuCare Pharmaceuticals,Inc.	6598a875-8be8-0928-e053-2a91aa0a064d	2024-06-06	Warnings	Exact identifier application applno (ANDA): 201446 application number: ANDA201446 ndc (product): 68071-4294

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 · 21 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
57297-852	My Way	levonorgestrel	LUPIN LIMITED	ANDA	Current
57297-852	My Way	levonorgestrel	LUPIN LIMITED	ANDA	Current
57297-852	My Way	levonorgestrel	LUPIN LIMITED	ANDA	Current
57297-853	Fallback Solo	levonorgestrel	LUPIN LIMITED	ANDA	Current
64122-605	AfterPill	levonorgestrel	Syzygy Healthcare Solutions, LLC PO Box 588, Westport, CT 06880	ANDA	Current
64122-605	AfterPill	levonorgestrel	Syzygy Healthcare Solutions, LLC PO Box 588, Westport, CT 06880	ANDA	Current
64122-605	AfterPill	levonorgestrel	Syzygy Healthcare Solutions, LLC PO Box 588, Westport, CT 06880	ANDA	Current
68071-4294	My Way	levonorgestrel	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4294	My Way	levonorgestrel	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4294	My Way	levonorgestrel	NuCare Pharmaceuticals,Inc.	ANDA	Current
68180-852	My Way	levonorgestrel	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-852	My Way	levonorgestrel	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-852	My Way	levonorgestrel	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-852	My Way	levonorgestrel	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-852	My Way	levonorgestrel	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-853	Fallback Solo	levonorgestrel	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-853	Fallback Solo	levonorgestrel	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-853	Fallback Solo	levonorgestrel	Lupin Pharmaceuticals, In	ANDA	Current
68180-853	Fallback Solo	levonorgestrel	Lupin Pharmaceuticals, Inc.	ANDA	Current
71205-361	My Way	levonorgestrel	Proficient Rx LP	ANDA	Current
76519-1164	LEVONORGESTREL	LEVONORGESTREL	H.J. Harkins Company, Inc.	ANDA	Current