Application 210917

Type: ANDA
Sponsor: INGENUS PHARMS LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LEUCOVORIN CALCIUM	LEUCOVORIN CALCIUM	INJECTABLE;INJECTION	EQ 10MG BASE/ML	No	No

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
A210917-001	LEUCOVORIN CALCIUM	LEUCOVORIN CALCIUM	EQ 500MG BASE/50ML (EQ 10MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS			2018-11-23

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A210917-001	LEUCOVORIN CALCIUM	EQ 500MG BASE/50ML (EQ 10MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS		2018-11-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210917-001	LEUCOVORIN CALCIUM	EQ 500MG BASE/50ML (EQ 10MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS		2018-11-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210917-001	LEUCOVORIN CALCIUM	EQ 500MG BASE/50ML (EQ 10MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS		2018-11-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210917-001	LEUCOVORIN CALCIUM	EQ 500MG BASE/50ML (EQ 10MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS		2018-11-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210917-001	LEUCOVORIN CALCIUM	EQ 500MG BASE/50ML (EQ 10MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS		2018-11-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210917-001	LEUCOVORIN CALCIUM	EQ 500MG BASE/50ML (EQ 10MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS		2018-11-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210917-001	LEUCOVORIN CALCIUM	EQ 500MG BASE/50ML (EQ 10MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS		2018-11-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210917-001	LEUCOVORIN CALCIUM	EQ 10MG BASE/ML	INJECTABLE / INJECTION		2018-11-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210917-001	LEUCOVORIN CALCIUM	EQ 500MG BASE/50ML (EQ 10MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS		2018-11-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210917-001	LEUCOVORIN CALCIUM	EQ 500MG BASE/50ML (EQ 10MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS		2018-11-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210917-001	LEUCOVORIN CALCIUM	EQ 10MG BASE/ML	INJECTABLE / INJECTION		2018-11-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210917-001	LEUCOVORIN CALCIUM	EQ 10MG BASE/ML	INJECTABLE / INJECTION		2018-11-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210917-001	LEUCOVORIN CALCIUM	EQ 10MG BASE/ML	INJECTABLE / INJECTION		2018-11-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210917-001	LEUCOVORIN CALCIUM	EQ 10MG BASE/ML	INJECTABLE / INJECTION		2018-11-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210917-001	LEUCOVORIN CALCIUM	EQ 10MG BASE/ML	INJECTABLE / INJECTION		2018-11-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210917-001	LEUCOVORIN CALCIUM	EQ 10MG BASE/ML	INJECTABLE / INJECTION		2018-11-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210917-001	LEUCOVORIN CALCIUM	EQ 10MG BASE/ML	INJECTABLE / INJECTION		2018-11-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210917-001	LEUCOVORIN CALCIUM	EQ 10MG BASE/ML	INJECTABLE / INJECTION		2018-11-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210917-001	LEUCOVORIN CALCIUM	EQ 10MG BASE/ML	INJECTABLE / INJECTION		2018-11-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210917-001	LEUCOVORIN CALCIUM	EQ 10MG BASE/ML	INJECTABLE / INJECTION		2018-11-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210917-001	LEUCOVORIN CALCIUM	EQ 10MG BASE/ML	INJECTABLE / INJECTION		2018-11-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210917-001	LEUCOVORIN CALCIUM	EQ 10MG BASE/ML	INJECTABLE / INJECTION		2018-11-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210917-001	LEUCOVORIN CALCIUM	EQ 10MG BASE/ML	INJECTABLE / INJECTION		2018-11-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210917-001	LEUCOVORIN CALCIUM	EQ 10MG BASE/ML	INJECTABLE / INJECTION		2018-11-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210917-001	LEUCOVORIN CALCIUM	EQ 10MG BASE/ML	INJECTABLE / INJECTION		2018-11-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210917-001	LEUCOVORIN CALCIUM	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2018-11-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210917-001	LEUCOVORIN CALCIUM	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2018-11-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210917-001	LEUCOVORIN CALCIUM	EQ 10MG BASE/ML	INJECTABLE / INJECTION		2018-11-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210917-001	LEUCOVORIN CALCIUM	EQ 10MG BASE/ML	INJECTABLE / INJECTION		2018-11-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210917-001	LEUCOVORIN CALCIUM	EQ 10MG BASE/ML	INJECTABLE / INJECTION		2018-11-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210917-001	LEUCOVORIN CALCIUM	EQ 10MG BASE/ML	INJECTABLE / INJECTION		2018-11-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210917-001	LEUCOVORIN CALCIUM	EQ 10MG BASE/ML	INJECTABLE / INJECTION		2018-11-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210917-001	LEUCOVORIN CALCIUM	EQ 10MG BASE/ML	INJECTABLE / INJECTION		2018-11-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210917-001	LEUCOVORIN CALCIUM	EQ 10MG BASE/ML	INJECTABLE / INJECTION		2018-11-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210917-001	LEUCOVORIN CALCIUM	EQ 10MG BASE/ML	INJECTABLE / INJECTION		2018-11-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210917-001	LEUCOVORIN CALCIUM	EQ 10MG BASE/ML	INJECTABLE / INJECTION		2018-11-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210917-001	LEUCOVORIN CALCIUM	EQ 10MG BASE/ML	INJECTABLE / INJECTION		2018-11-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210917-001	LEUCOVORIN CALCIUM	EQ 10MG BASE/ML	INJECTABLE / INJECTION		2018-11-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210917-001	LEUCOVORIN CALCIUM	EQ 10MG BASE/ML	INJECTABLE / INJECTION		2018-11-23	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210917-001	LEUCOVORIN CALCIUM	EQ 10MG BASE/ML	INJECTABLE / INJECTION		2018-11-23	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-09-15 20:21 UTC	2019-09	A210917-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210917-001	AP	1	`ea99ee380514…`

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 2 · 24 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Leucovorin Calcium	LEUCOVORIN CALCIUM	American Health Packaging	f7004cbd-9827-466e-9683-adce4f13c6a6	2026-07-01	Warnings, Adverse reactions	Name fallback brand name: Leucovorin Calcium generic name: LEUCOVORIN CALCIUM
Leucovorin Calcium	LEUCOVORIN CALCIUM	Sagent Pharmaceuticals	c0cbcbf6-6fd2-4cf3-877a-bb0fe3df4e59	2026-06-16	Warnings, Adverse reactions	Name fallback brand name: Leucovorin Calcium generic name: LEUCOVORIN CALCIUM
Leucovorin Calcium	LEUCOVORIN CALCIUM	Teva Pharmaceuticals USA, Inc.	94669fc8-3c1c-4228-be27-09a1cd468c36	2026-03-31	Warnings, Adverse reactions	Name fallback brand name: Leucovorin Calcium generic name: LEUCOVORIN CALCIUM
Leucovorin Calcium	LEUCOVORIN CALCIUM	Major Pharmaceuticals	273407f5-0be2-435a-b7a8-f21be8ffbb3c	2026-03-27	Warnings, Adverse reactions	Name fallback brand name: Leucovorin Calcium generic name: LEUCOVORIN CALCIUM
LEUCOVORIN CALCIUM	LEUCOVORIN CALCIUM	Leading Pharma, LLC	c8102043-79f2-421a-b849-94bac19007a6	2026-03-27	Warnings, Adverse reactions	Name fallback brand name: LEUCOVORIN CALCIUM generic name: LEUCOVORIN CALCIUM
Leucovorin Calcium	LEUCOVORIN CALCIUM	Ingenus Pharmaceuticals, LLC	7409cdee-9093-47af-a4c4-2c55ce1b6361	2026-03-18	Warnings, Adverse reactions	Name fallback brand name: Leucovorin Calcium generic name: LEUCOVORIN CALCIUM
VYKOURA	LEUCOVORIN CALCIUM	Avyxa Pharma, LLC	d122b875-435e-4e00-b945-7a0546df95c2	2026-03-12	Warnings, Adverse reactions	Name fallback generic name: LEUCOVORIN CALCIUM
Leucovorin Calcium	LEUCOVORIN CALCIUM	Sagent Pharmaceuticals	9d0e5356-ff39-4a8e-944c-e808a21ef4b2	2026-03-11	Warnings, Adverse reactions	Name fallback brand name: Leucovorin Calcium generic name: LEUCOVORIN CALCIUM
Leucovorin Calcium	LEUCOVORIN CALCIUM	Hikma Pharmaceuticals USA Inc.	33663425-4731-4977-9127-9e59b6b91497	2026-03-10	Warnings, Adverse reactions	Name fallback brand name: Leucovorin Calcium generic name: LEUCOVORIN CALCIUM
Leucovorin Calcium	LEUCOVORIN CALCIUM	GLENMARK PHARMACEUTICALS INC., USA	79d023ab-7d77-48c1-8f47-ea322fd58c2b	2025-12-09	Warnings, Adverse reactions	Name fallback brand name: Leucovorin Calcium generic name: LEUCOVORIN CALCIUM
Leucovorin Calcium	LEUCOVORIN CALCIUM	Gland Pharma Limited	968b192b-72f3-41b0-a1f5-bab8a96d3419	2025-11-13	Warnings, Adverse reactions	Name fallback brand name: Leucovorin Calcium generic name: LEUCOVORIN CALCIUM
leucovorin calcium	LEUCOVORIN CALCIUM	BluePoint Laboratories	f579879c-7d53-4663-8ad8-84b8b645cda5	2025-09-29	Warnings, Adverse reactions	Name fallback brand name: leucovorin calcium generic name: LEUCOVORIN CALCIUM
leucovorin calcium	LEUCOVORIN CALCIUM	Meitheal Pharmaceuticals Inc.	9df20901-6980-4d4e-89ec-40f3c1f91852	2025-03-19	Warnings, Adverse reactions	Name fallback brand name: leucovorin calcium generic name: LEUCOVORIN CALCIUM
Leucovorin Calcium	LEUCOVORIN CALCIUM	Slate Run Pharmaceuticals, LLC	d8bdd60c-9a1c-4ef4-ba6b-b911849128f1	2024-12-27	Warnings, Adverse reactions	Name fallback brand name: Leucovorin Calcium generic name: LEUCOVORIN CALCIUM
Leucovorin calcium	LEUCOVORIN CALCIUM	Fresenius Kabi USA, LLC	4b72d1fd-f389-45d9-b43b-510b45c92263	2024-10-14	Warnings, Adverse reactions	Name fallback brand name: Leucovorin calcium generic name: LEUCOVORIN CALCIUM
Leucovorin Calcium	LEUCOVORIN CALCIUM	Fresenius Kabi USA, LLC	ab691d4e-e0d1-4ba1-9c7a-1cdcfcc3c17c	2024-10-14	Warnings, Adverse reactions	Name fallback brand name: Leucovorin Calcium generic name: LEUCOVORIN CALCIUM
Leucovorin calcium	LEUCOVORIN CALCIUM	Fresenius Kabi USA, LLC	d5d4f0fd-7520-43a9-9acc-f7e117e1f6ee	2024-10-14	Warnings, Adverse reactions	Name fallback brand name: Leucovorin calcium generic name: LEUCOVORIN CALCIUM
Leucovorin Calcium	LEUCOVORIN CALCIUM	Epic Pharma LLC	2627a485-05b5-4dab-ac20-dc840e5c469d	2023-11-08	Warnings, Adverse reactions	Name fallback brand name: Leucovorin Calcium generic name: LEUCOVORIN CALCIUM
Leucovorin Calcium	LEUCOVORIN CALCIUM	Hikma Pharmaceuticals USA Inc.	f198ab39-9394-4280-be44-93a88264a450	2022-06-23	Warnings, Adverse reactions	Name fallback brand name: Leucovorin Calcium generic name: LEUCOVORIN CALCIUM
LEUCOVORIN CALCIUM	LEUCOVORIN CALCIUM	Mylan Institutional LLC	1cb701ca-2478-4268-9d69-80293965d59d	2022-06-01	Warnings, Adverse reactions	Name fallback brand name: LEUCOVORIN CALCIUM generic name: LEUCOVORIN CALCIUM

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50742-464	LEUCOVORIN CALCIUM	LEUCOVORIN CALCIUM	Ingenus Pharmaceuticals, LLC	ANDA	Current
50742-464	LEUCOVORIN CALCIUM	LEUCOVORIN CALCIUM	Ingenus Pharmaceuticals, LLC	ANDA	Current
50742-464	LEUCOVORIN CALCIUM	LEUCOVORIN CALCIUM	Ingenus Pharmaceuticals, LLC	ANDA	Current