Application 211132

Type: ANDA
Sponsor: RICONPHARMA LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LEUCOVORIN CALCIUM	LEUCOVORIN CALCIUM	TABLET;ORAL	EQ 5MG BASE	No	No
002	LEUCOVORIN CALCIUM	LEUCOVORIN CALCIUM	TABLET;ORAL	EQ 10MG BASE	No	No
003	LEUCOVORIN CALCIUM	LEUCOVORIN CALCIUM	TABLET;ORAL	EQ 15MG BASE	No	No
004	LEUCOVORIN CALCIUM	LEUCOVORIN CALCIUM	TABLET;ORAL	EQ 25MG BASE	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A211132-001	LEUCOVORIN CALCIUM	LEUCOVORIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB		2020-07-30
A211132-002	LEUCOVORIN CALCIUM	LEUCOVORIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB		2020-07-30
A211132-003	LEUCOVORIN CALCIUM	LEUCOVORIN CALCIUM	EQ 15MG BASE	TABLET / ORAL	AB		2020-07-30
A211132-004	LEUCOVORIN CALCIUM	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB	RS	2020-07-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A211132-001	AB
A211132-002	AB
A211132-003	AB
A211132-004	AB

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 4 · 152 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A211132-001	LEUCOVORIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB		2020-07-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211132-002	LEUCOVORIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB		2020-07-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211132-003	LEUCOVORIN CALCIUM	EQ 15MG BASE	TABLET / ORAL	AB		2020-07-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211132-004	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB	RS	2020-07-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211132-001	LEUCOVORIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB		2020-07-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211132-002	LEUCOVORIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB		2020-07-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211132-003	LEUCOVORIN CALCIUM	EQ 15MG BASE	TABLET / ORAL	AB		2020-07-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211132-004	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB		2020-07-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211132-001	LEUCOVORIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB		2020-07-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211132-002	LEUCOVORIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB		2020-07-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211132-003	LEUCOVORIN CALCIUM	EQ 15MG BASE	TABLET / ORAL	AB		2020-07-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211132-004	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB		2020-07-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211132-001	LEUCOVORIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB		2020-07-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211132-002	LEUCOVORIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB		2020-07-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211132-003	LEUCOVORIN CALCIUM	EQ 15MG BASE	TABLET / ORAL	AB		2020-07-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211132-004	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB		2020-07-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211132-001	LEUCOVORIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB		2020-07-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211132-002	LEUCOVORIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB		2020-07-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211132-003	LEUCOVORIN CALCIUM	EQ 15MG BASE	TABLET / ORAL	AB		2020-07-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211132-004	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB		2020-07-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211132-001	LEUCOVORIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB		2020-07-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211132-002	LEUCOVORIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB		2020-07-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211132-003	LEUCOVORIN CALCIUM	EQ 15MG BASE	TABLET / ORAL	AB		2020-07-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211132-004	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB		2020-07-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211132-001	LEUCOVORIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB		2020-07-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211132-002	LEUCOVORIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB		2020-07-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211132-003	LEUCOVORIN CALCIUM	EQ 15MG BASE	TABLET / ORAL	AB		2020-07-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211132-004	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB		2020-07-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211132-001	LEUCOVORIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB		2020-07-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211132-002	LEUCOVORIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB		2020-07-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211132-003	LEUCOVORIN CALCIUM	EQ 15MG BASE	TABLET / ORAL	AB		2020-07-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211132-004	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB		2020-07-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211132-001	LEUCOVORIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB		2020-07-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211132-002	LEUCOVORIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB		2020-07-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211132-003	LEUCOVORIN CALCIUM	EQ 15MG BASE	TABLET / ORAL	AB		2020-07-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211132-004	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB		2020-07-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211132-001	LEUCOVORIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB		2020-07-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211132-002	LEUCOVORIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB		2020-07-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211132-003	LEUCOVORIN CALCIUM	EQ 15MG BASE	TABLET / ORAL	AB		2020-07-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211132-004	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB		2020-07-30	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 152 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A211132-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211132-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211132-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211132-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211132-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211132-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211132-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211132-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211132-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211132-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211132-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211132-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211132-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211132-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211132-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211132-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211132-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211132-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211132-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211132-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211132-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211132-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211132-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211132-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211132-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211132-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211132-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211132-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211132-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211132-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211132-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211132-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211132-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211132-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211132-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211132-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211132-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211132-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211132-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211132-004	AB	1	`d8e5a09893c0…`

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
Leucovorin Calcium	LEUCOVORIN CALCIUM	Major Pharmaceuticals	273407f5-0be2-435a-b7a8-f21be8ffbb3c	2026-03-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211132 application number: ANDA211132
Leucovorin Calcium	LEUCOVORIN CALCIUM	Ingenus Pharmaceuticals, LLC	7409cdee-9093-47af-a4c4-2c55ce1b6361	2026-03-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211132 application number: ANDA211132 ndc (product): 50742-181 ndc (product): 50742-184 ndc (product): 50742-183 ndc (product): 50742-182

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50742-181	Leucovorin Calcium	Leucovorin Calcium	Ingenus Pharmaceuticals, LLC	ANDA	Current
50742-181	Leucovorin Calcium	Leucovorin Calcium	Ingenus Pharmaceuticals, LLC	ANDA	Current
50742-182	Leucovorin Calcium	Leucovorin Calcium	Ingenus Pharmaceuticals, LLC	ANDA	Current
50742-182	Leucovorin Calcium	Leucovorin Calcium	Ingenus Pharmaceuticals, LLC	ANDA	Current
50742-183	Leucovorin Calcium	Leucovorin Calcium	Ingenus Pharmaceuticals, LLC	ANDA	Current
50742-183	Leucovorin Calcium	Leucovorin Calcium	Ingenus Pharmaceuticals, LLC	ANDA	Current
50742-184	Leucovorin Calcium	Leucovorin Calcium	Ingenus Pharmaceuticals, LLC	ANDA	Current
50742-184	Leucovorin Calcium	Leucovorin Calcium	Ingenus Pharmaceuticals, LLC	ANDA	Current