Application 040056

Type: ANDA
Sponsor: WEST-WARD PHARMS INT

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 200MG BASE/VIAL	No	Yes

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

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
A040056-001	LEUCOVORIN CALCIUM PRESERVATIVE FREE	LEUCOVORIN CALCIUM	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1995-05-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040056-001	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 2 · 41 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
2026-02-19 14:30 UTC	2026-02	A040056-001	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1995-05-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040056-001	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1995-05-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040056-001	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1995-05-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040056-001	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1995-05-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040056-001	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1995-05-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040056-001	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1995-05-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040056-001	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1995-05-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040056-001	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1995-05-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040056-001	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1995-05-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040056-001	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1995-05-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040056-001	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1995-05-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040056-001	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1995-05-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040056-001	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1995-05-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040056-001	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1995-05-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040056-001	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1995-05-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040056-001	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1995-05-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040056-001	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1995-05-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040056-001	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1995-05-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040056-001	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1995-05-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040056-001	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1995-05-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040056-001	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1995-05-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040056-001	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1995-05-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040056-001	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1995-05-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040056-001	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1995-05-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040056-001	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1995-05-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040056-001	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1995-05-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040056-001	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1995-05-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040056-001	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1995-05-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040056-001	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1995-05-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040056-001	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1995-05-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040056-001	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1995-05-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040056-001	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1995-05-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040056-001	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1995-05-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040056-001	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1995-05-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040056-001	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1995-05-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040056-001	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1995-05-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040056-001	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1995-05-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040056-001	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1995-05-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040056-001	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1995-05-23	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040056-001	LEUCOVORIN CALCIUM PRESERVATIVE FREE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1995-05-23	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A040056-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040056-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040056-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040056-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040056-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040056-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040056-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040056-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040056-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040056-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040056-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040056-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040056-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040056-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040056-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040056-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040056-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040056-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040056-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040056-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040056-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040056-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040056-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040056-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040056-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040056-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040056-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040056-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040056-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040056-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040056-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040056-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040056-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040056-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040056-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040056-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040056-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040056-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040056-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040056-001	AP	1	`cb3db0bc1861…`

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
Leucovorin Calcium	LEUCOVORIN CALCIUM	Hikma Pharmaceuticals USA Inc.	f198ab39-9394-4280-be44-93a88264a450	2022-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040056 application number: ANDA040056 ndc (product): 0143-9368
Leucovorin Calcium	LEUCOVORIN CALCIUM	BluePoint Laboratories	e9b47126-8b52-43ff-85c4-33d32b3d8326	2022-01-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040056 application number: ANDA040056 ndc (product): 68001-417
Leucovorin Calcium	LEUCOVORIN CALCIUM	Hikma Pharmaceuticals USA Inc.	cc52077f-5663-4f79-a273-0aecf655e038	2021-10-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040056 application number: ANDA040056 ndc (product): 0143-9553

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
0143-9368	Leucovorin Calcium	Leucovorin Calcium	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9368	Leucovorin Calcium	Leucovorin Calcium	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9553	Leucovorin Calcium	Leucovorin Calcium	West-Ward Pharmaceuticals Corp	ANDA	Current
0143-9553	Leucovorin Calcium	Leucovorin Calcium	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9553	Leucovorin Calcium	Leucovorin Calcium	Hikma Pharmaceuticals USA Inc.	ANDA	Current
68001-417	Leucovorin Calcium	Leucovorin Calcium	BluePoint Laboratories	ANDA	Current
68001-417	Leucovorin Calcium	Leucovorin Calcium	BluePoint Laboratories	ANDA	Current
68001-417	Leucovorin Calcium	Leucovorin Calcium	BluePoint Laboratories	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
17747	SUPPL	2012-08-30