Application 211002

Type: ANDA
Sponsor: MEITHEAL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LEVOLEUCOVORIN CALCIUM	LEVOLEUCOVORIN CALCIUM	SOLUTION;INTRAVENOUS	EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)	No	No
002	LEVOLEUCOVORIN CALCIUM	LEVOLEUCOVORIN CALCIUM	SOLUTION;INTRAVENOUS	EQ 250MG BASE/25ML (EQ 10MG BASE/ML)	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A211002-001	LEVOLEUCOVORIN CALCIUM	LEVOLEUCOVORIN CALCIUM	EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RS	2019-08-16
A211002-002	LEVOLEUCOVORIN CALCIUM	LEVOLEUCOVORIN CALCIUM	EQ 250MG BASE/25ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS			2019-08-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211002-001	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 2 of 3 · 86 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
2019-12-13 00:20 UTC	2019-12	A211002-001	LEVOLEUCOVORIN CALCIUM	EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	AP		2019-08-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A211002-002	LEVOLEUCOVORIN CALCIUM	EQ 250MG BASE/25ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	AP		2019-08-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211002-001	LEVOLEUCOVORIN CALCIUM	EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	AP		2019-08-16	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A211002-002	LEVOLEUCOVORIN CALCIUM	EQ 250MG BASE/25ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	AP		2019-08-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211002-001	LEVOLEUCOVORIN CALCIUM	EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	AP		2019-08-16	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A211002-002	LEVOLEUCOVORIN CALCIUM	EQ 250MG BASE/25ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	AP		2019-08-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211002-001	LEVOLEUCOVORIN CALCIUM	EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	AP		2019-08-16	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211002-002	LEVOLEUCOVORIN CALCIUM	EQ 250MG BASE/25ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	AP		2019-08-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211002-001	LEVOLEUCOVORIN CALCIUM	EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	AP		2019-08-16	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A211002-002	LEVOLEUCOVORIN CALCIUM	EQ 250MG BASE/25ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	AP		2019-08-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211002-001	LEVOLEUCOVORIN CALCIUM	EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	AP		2019-08-16	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A211002-002	LEVOLEUCOVORIN CALCIUM	EQ 250MG BASE/25ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	AP		2019-08-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211002-001	LEVOLEUCOVORIN CALCIUM	EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	AP		2019-08-16	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A211002-002	LEVOLEUCOVORIN CALCIUM	EQ 250MG BASE/25ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	AP		2019-08-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211002-001	LEVOLEUCOVORIN CALCIUM	EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	AP		2019-08-16	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A211002-002	LEVOLEUCOVORIN CALCIUM	EQ 250MG BASE/25ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	AP		2019-08-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211002-001	LEVOLEUCOVORIN CALCIUM	EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	AP		2019-08-16	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A211002-002	LEVOLEUCOVORIN CALCIUM	EQ 250MG BASE/25ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	AP		2019-08-16	`b00525d2431f…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211002-001	LEVOLEUCOVORIN CALCIUM	EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RS	2019-08-16	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211002-002	LEVOLEUCOVORIN CALCIUM	EQ 250MG BASE/25ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS			2019-08-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211002-001	LEVOLEUCOVORIN CALCIUM	EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RS	2019-08-16	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A211002-002	LEVOLEUCOVORIN CALCIUM	EQ 250MG BASE/25ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS			2019-08-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211002-001	LEVOLEUCOVORIN CALCIUM	EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RS	2019-08-16	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A211002-002	LEVOLEUCOVORIN CALCIUM	EQ 250MG BASE/25ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS			2019-08-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211002-001	LEVOLEUCOVORIN CALCIUM	EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RS	2019-08-16	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211002-002	LEVOLEUCOVORIN CALCIUM	EQ 250MG BASE/25ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS			2019-08-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211002-001	LEVOLEUCOVORIN CALCIUM	EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RS	2019-08-16	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211002-002	LEVOLEUCOVORIN CALCIUM	EQ 250MG BASE/25ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS			2019-08-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211002-001	LEVOLEUCOVORIN CALCIUM	EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RS	2019-08-16	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211002-002	LEVOLEUCOVORIN CALCIUM	EQ 250MG BASE/25ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS			2019-08-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211002-001	LEVOLEUCOVORIN CALCIUM	EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RS	2019-08-16	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211002-002	LEVOLEUCOVORIN CALCIUM	EQ 250MG BASE/25ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS			2019-08-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211002-001	LEVOLEUCOVORIN CALCIUM	EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RS	2019-08-16	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A211002-002	LEVOLEUCOVORIN CALCIUM	EQ 250MG BASE/25ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS			2019-08-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211002-001	LEVOLEUCOVORIN CALCIUM	EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RS	2019-08-16	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A211002-002	LEVOLEUCOVORIN CALCIUM	EQ 250MG BASE/25ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS			2019-08-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211002-001	LEVOLEUCOVORIN CALCIUM	EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	AP		2019-08-16	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211002-002	LEVOLEUCOVORIN CALCIUM	EQ 250MG BASE/25ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	AP		2019-08-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211002-001	LEVOLEUCOVORIN CALCIUM	EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	AP		2019-08-16	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A211002-002	LEVOLEUCOVORIN CALCIUM	EQ 250MG BASE/25ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	AP		2019-08-16	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 59 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A211002-001	AP	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A211002-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211002-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211002-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211002-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211002-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211002-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211002-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211002-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211002-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211002-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211002-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211002-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211002-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211002-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211002-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211002-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211002-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211002-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211002-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211002-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211002-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211002-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211002-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A211002-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211002-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A211002-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211002-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A211002-002	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211002-001	AP	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211002-002	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211002-001	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A211002-002	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211002-001	AP	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A211002-002	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211002-001	AP	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A211002-002	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211002-001	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A211002-002	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211002-001	AP	1	`b00525d2431f…`

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
Levoleucovorin	LEVOLEUCOVORIN CALCIUM	Meitheal Pharmaceuticals Inc.	059a3306-6207-497f-a947-33198f18761f	2023-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211002 application number: ANDA211002 ndc (product): 71288-105

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
71288-105	Levoleucovorin	levoleucovorin calcium	Meitheal Pharmaceuticals Inc.	ANDA	Current
71288-105	Levoleucovorin	levoleucovorin calcium	Meitheal Pharmaceuticals Inc.	ANDA	Current
71288-105	Levoleucovorin	levoleucovorin calcium	Meitheal Pharmaceuticals Inc.	ANDA	Current