Application 213929

Type: ANDA
Sponsor: LEADING PHARMA 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 1.

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	Approval date
A213929-001	LEUCOVORIN CALCIUM	LEUCOVORIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2020-10-22
A213929-002	LEUCOVORIN CALCIUM	LEUCOVORIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2020-10-22
A213929-003	LEUCOVORIN CALCIUM	LEUCOVORIN CALCIUM	EQ 15MG BASE	TABLET / ORAL	AB	2020-10-22
A213929-004	LEUCOVORIN CALCIUM	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB	2020-10-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213929-001	AB
A213929-002	AB
A213929-003	AB
A213929-004	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 · 144 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A213929-001	LEUCOVORIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2020-10-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213929-002	LEUCOVORIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2020-10-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213929-003	LEUCOVORIN CALCIUM	EQ 15MG BASE	TABLET / ORAL	AB	2020-10-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213929-004	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB	2020-10-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213929-001	LEUCOVORIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2020-10-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213929-002	LEUCOVORIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2020-10-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213929-003	LEUCOVORIN CALCIUM	EQ 15MG BASE	TABLET / ORAL	AB	2020-10-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213929-004	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB	2020-10-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213929-001	LEUCOVORIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2020-10-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213929-002	LEUCOVORIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2020-10-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213929-003	LEUCOVORIN CALCIUM	EQ 15MG BASE	TABLET / ORAL	AB	2020-10-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213929-004	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB	2020-10-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213929-001	LEUCOVORIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2020-10-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213929-002	LEUCOVORIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2020-10-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213929-003	LEUCOVORIN CALCIUM	EQ 15MG BASE	TABLET / ORAL	AB	2020-10-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213929-004	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB	2020-10-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213929-001	LEUCOVORIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2020-10-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213929-002	LEUCOVORIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2020-10-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213929-003	LEUCOVORIN CALCIUM	EQ 15MG BASE	TABLET / ORAL	AB	2020-10-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213929-004	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB	2020-10-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213929-001	LEUCOVORIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2020-10-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213929-002	LEUCOVORIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2020-10-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213929-003	LEUCOVORIN CALCIUM	EQ 15MG BASE	TABLET / ORAL	AB	2020-10-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213929-004	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB	2020-10-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213929-001	LEUCOVORIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2020-10-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213929-002	LEUCOVORIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2020-10-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213929-003	LEUCOVORIN CALCIUM	EQ 15MG BASE	TABLET / ORAL	AB	2020-10-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213929-004	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB	2020-10-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213929-001	LEUCOVORIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2020-10-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213929-002	LEUCOVORIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2020-10-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213929-003	LEUCOVORIN CALCIUM	EQ 15MG BASE	TABLET / ORAL	AB	2020-10-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213929-004	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB	2020-10-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213929-001	LEUCOVORIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2020-10-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213929-002	LEUCOVORIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2020-10-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213929-003	LEUCOVORIN CALCIUM	EQ 15MG BASE	TABLET / ORAL	AB	2020-10-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213929-004	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB	2020-10-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213929-001	LEUCOVORIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2020-10-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213929-002	LEUCOVORIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2020-10-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213929-003	LEUCOVORIN CALCIUM	EQ 15MG BASE	TABLET / ORAL	AB	2020-10-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213929-004	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB	2020-10-22	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 144 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A213929-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213929-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213929-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213929-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213929-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213929-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213929-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213929-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213929-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213929-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213929-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213929-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213929-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213929-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213929-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213929-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213929-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213929-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213929-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213929-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213929-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213929-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213929-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213929-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213929-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213929-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213929-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213929-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213929-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213929-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213929-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213929-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213929-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213929-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213929-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213929-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213929-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213929-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213929-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213929-004	AB	1	`d06236e962d9…`

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	Leading Pharma, LLC	c8102043-79f2-421a-b849-94bac19007a6	2026-03-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213929 application number: ANDA213929 ndc (product): 69315-186 ndc (product): 69315-187 ndc (product): 69315-185 ndc (product): 69315-184
LEUCOVORIN CALCIUM	LEUCOVORIN CALCIUM	Proficient Rx LP	46d12bd0-ec7d-4e2c-aeed-b8aa88e6dc5c	2022-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213929 application number: ANDA213929 ndc (product): 71205-908

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
69315-184	LEUCOVORIN CALCIUM	LEUCOVORIN CALCIUM	Leading Pharma, LLC	ANDA	Current
69315-184	LEUCOVORIN CALCIUM	LEUCOVORIN CALCIUM	Leading Pharma, LLC	ANDA	Current
69315-185	LEUCOVORIN CALCIUM	LEUCOVORIN CALCIUM	Leading Pharma, LLC	ANDA	Current
69315-185	LEUCOVORIN CALCIUM	LEUCOVORIN CALCIUM	Leading Pharma, LLC	ANDA	Current
69315-186	LEUCOVORIN CALCIUM	LEUCOVORIN CALCIUM	Leading Pharma, LLC	ANDA	Current
69315-186	LEUCOVORIN CALCIUM	LEUCOVORIN CALCIUM	Leading Pharma, LLC	ANDA	Current
69315-187	LEUCOVORIN CALCIUM	LEUCOVORIN CALCIUM	Leading Pharma, LLC	ANDA	Current
69315-187	LEUCOVORIN CALCIUM	LEUCOVORIN CALCIUM	Leading Pharma, LLC	ANDA	Current
71205-908	LEUCOVORIN CALCIUM	LEUCOVORIN CALCIUM	Proficient Rx LP	ANDA	Current
71205-908	LEUCOVORIN CALCIUM	LEUCOVORIN CALCIUM	Proficient Rx LP	ANDA	Current