Application 203800

Type: ANDA
Sponsor: MYLAN LABS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LEUCOVORIN CALCIUM PRESERVATIVE FREE	LEUCOVORIN CALCIUM	INJECTABLE;INJECTION	EQ 100MG BASE/VIAL	No	No
002	LEUCOVORIN CALCIUM PRESERVATIVE FREE	LEUCOVORIN CALCIUM	INJECTABLE;INJECTION	EQ 200MG BASE/VIAL	No	No
003	LEUCOVORIN CALCIUM PRESERVATIVE FREE	LEUCOVORIN CALCIUM	INJECTABLE;INJECTION	EQ 350MG BASE/VIAL	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A203800-001	LEUCOVORIN CALCIUM PRESERVATIVE FREE	LEUCOVORIN CALCIUM	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	2017-05-19
A203800-002	LEUCOVORIN CALCIUM PRESERVATIVE FREE	LEUCOVORIN CALCIUM	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	2017-05-19
A203800-003	LEUCOVORIN CALCIUM PRESERVATIVE FREE	LEUCOVORIN CALCIUM	EQ 350MG BASE/VIAL	INJECTABLE / INJECTION	AP	2017-05-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A203800-001	AP
A203800-002	AP
A203800-003	AP

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 · 123 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	A203800-001	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	2017-05-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203800-002	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	2017-05-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203800-003	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 350MG BASE/VIAL	INJECTABLE / INJECTION	AP	2017-05-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203800-001	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	2017-05-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203800-002	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	2017-05-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203800-003	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 350MG BASE/VIAL	INJECTABLE / INJECTION	AP	2017-05-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203800-001	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	2017-05-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203800-002	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	2017-05-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203800-003	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 350MG BASE/VIAL	INJECTABLE / INJECTION	AP	2017-05-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203800-001	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	2017-05-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203800-002	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	2017-05-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203800-003	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 350MG BASE/VIAL	INJECTABLE / INJECTION	AP	2017-05-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203800-001	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	2017-05-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203800-002	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	2017-05-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203800-003	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 350MG BASE/VIAL	INJECTABLE / INJECTION	AP	2017-05-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203800-001	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	2017-05-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203800-002	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	2017-05-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203800-003	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 350MG BASE/VIAL	INJECTABLE / INJECTION	AP	2017-05-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203800-001	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	2017-05-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203800-002	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	2017-05-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203800-003	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 350MG BASE/VIAL	INJECTABLE / INJECTION	AP	2017-05-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203800-001	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	2017-05-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203800-002	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	2017-05-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203800-003	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 350MG BASE/VIAL	INJECTABLE / INJECTION	AP	2017-05-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203800-001	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	2017-05-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203800-002	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	2017-05-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203800-003	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 350MG BASE/VIAL	INJECTABLE / INJECTION	AP	2017-05-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203800-001	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	2017-05-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203800-002	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	2017-05-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203800-003	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 350MG BASE/VIAL	INJECTABLE / INJECTION	AP	2017-05-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203800-001	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	2017-05-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203800-002	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	2017-05-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203800-003	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 350MG BASE/VIAL	INJECTABLE / INJECTION	AP	2017-05-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203800-001	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	2017-05-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203800-002	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	2017-05-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203800-003	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 350MG BASE/VIAL	INJECTABLE / INJECTION	AP	2017-05-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203800-001	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	2017-05-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203800-002	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	2017-05-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203800-003	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 350MG BASE/VIAL	INJECTABLE / INJECTION	AP	2017-05-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203800-001	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	2017-05-19	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	A203800-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203800-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203800-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203800-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203800-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203800-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203800-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203800-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203800-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203800-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203800-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203800-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203800-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203800-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203800-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203800-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203800-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203800-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203800-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203800-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203800-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203800-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203800-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203800-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203800-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203800-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203800-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203800-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203800-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203800-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203800-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203800-002	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203800-003	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203800-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203800-002	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203800-003	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203800-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203800-002	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203800-003	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203800-001	AP	1	`8072bd15b7f6…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LEUCOVORIN CALCIUM	LEUCOVORIN CALCIUM	Mylan Institutional LLC	1cb701ca-2478-4268-9d69-80293965d59d	2022-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203800 application number: ANDA203800 ndc (product): 67457-529 ndc (product): 67457-528 ndc (product): 67457-530

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
67457-528	LEUCOVORIN CALCIUM	LEUCOVORIN CALCIUM	Mylan Institutional LLC	ANDA	Current
67457-528	LEUCOVORIN CALCIUM	LEUCOVORIN CALCIUM	Mylan Institutional LLC	ANDA	Current
67457-528	LEUCOVORIN CALCIUM	LEUCOVORIN CALCIUM	Mylan Institutional LLC	ANDA	Current
67457-528	LEUCOVORIN CALCIUM	LEUCOVORIN CALCIUM	Mylan Institutional LLC	ANDA	Current
67457-529	LEUCOVORIN CALCIUM	LEUCOVORIN CALCIUM	Mylan Institutional LLC	ANDA	Current
67457-529	LEUCOVORIN CALCIUM	LEUCOVORIN CALCIUM	Mylan Institutional LLC	ANDA	Current
67457-529	LEUCOVORIN CALCIUM	LEUCOVORIN CALCIUM	Mylan Institutional LLC	ANDA	Current
67457-529	LEUCOVORIN CALCIUM	LEUCOVORIN CALCIUM	Mylan Institutional LLC	ANDA	Current
67457-530	LEUCOVORIN CALCIUM	LEUCOVORIN CALCIUM	Mylan Institutional LLC	ANDA	Current
67457-530	LEUCOVORIN CALCIUM	LEUCOVORIN CALCIUM	Mylan Institutional LLC	ANDA	Current
67457-530	LEUCOVORIN CALCIUM	LEUCOVORIN CALCIUM	Mylan Institutional LLC	ANDA	Current
67457-530	LEUCOVORIN CALCIUM	LEUCOVORIN CALCIUM	Mylan Institutional LLC	ANDA	Current