Application 071199

Type: ANDA
Sponsor: BARR

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A071199-001	LEUCOVORIN CALCIUM	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB		1987-09-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A071199-001	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 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	A071199-001	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB	1987-09-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071199-001	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB	1987-09-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071199-001	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB	1987-09-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071199-001	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB	1987-09-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071199-001	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB	1987-09-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071199-001	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB	1987-09-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071199-001	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB	1987-09-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071199-001	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB	1987-09-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071199-001	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB	1987-09-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071199-001	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB	1987-09-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071199-001	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB	1987-09-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071199-001	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB	1987-09-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071199-001	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB	1987-09-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071199-001	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB	1987-09-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071199-001	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB	1987-09-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071199-001	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB	1987-09-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071199-001	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB	1987-09-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071199-001	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB	1987-09-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071199-001	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB	1987-09-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071199-001	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB	1987-09-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071199-001	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB	1987-09-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071199-001	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB	1987-09-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071199-001	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB	1987-09-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071199-001	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB	1987-09-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071199-001	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB	1987-09-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071199-001	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB	1987-09-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071199-001	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB	1987-09-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071199-001	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB	1987-09-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071199-001	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB	1987-09-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071199-001	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB	1987-09-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071199-001	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB	1987-09-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071199-001	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB	1987-09-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071199-001	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB	1987-09-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071199-001	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB	1987-09-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071199-001	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB	1987-09-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071199-001	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB	1987-09-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071199-001	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB	1987-09-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071199-001	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB	1987-09-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A071199-001	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB	1987-09-24	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A071199-001	LEUCOVORIN CALCIUM	EQ 25MG BASE	TABLET / ORAL	AB	1987-09-24	`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	A071199-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071199-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071199-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071199-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071199-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071199-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071199-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071199-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071199-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071199-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071199-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071199-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071199-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071199-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071199-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071199-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071199-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071199-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071199-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071199-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071199-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071199-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071199-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071199-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071199-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071199-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071199-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071199-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071199-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071199-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071199-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071199-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071199-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071199-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071199-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071199-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071199-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071199-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A071199-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A071199-001	AB	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 · 2 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	Exact identifier application applno (ANDA): 071199 application number: ANDA071199 ndc (product): 60687-227
Leucovorin Calcium	LEUCOVORIN CALCIUM	Teva Pharmaceuticals USA, Inc.	94669fc8-3c1c-4228-be27-09a1cd468c36	2026-03-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071199 application number: ANDA071199 ndc (product): 0555-0485

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 13 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0555-0485	Leucovorin Calcium	Leucovorin Calcium	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-0485	Leucovorin Calcium	Leucovorin Calcium	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-0485	Leucovorin Calcium	Leucovorin Calcium	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-0485	Leucovorin Calcium	Leucovorin Calcium	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-0485	Leucovorin Calcium	Leucovorin Calcium	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-0485	Leucovorin Calcium	Leucovorin Calcium	Teva Pharmaceuticals USA, Inc.	ANDA	Current
51079-582	Leucovorin Calcium	Leucovorin Calcium	Mylan Institutional Inc.	ANDA	Current
51079-582	Leucovorin Calcium	Leucovorin Calcium	Mylan Institutional Inc.	ANDA	Current
51079-582	Leucovorin Calcium	Leucovorin Calcium	Mylan institutional Inc.	ANDA	Current
60687-227	Leucovorin Calcium	Leucovorin Calcium	American Health Packaging	ANDA	Current
60687-227	Leucovorin Calcium	Leucovorin Calcium	American Health Packaging	ANDA	Current
60687-227	Leucovorin Calcium	Leucovorin Calcium	American Health Packaging	ANDA	Current
60687-227	Leucovorin Calcium	Leucovorin Calcium	American Health Packaging	ANDA	Current