Application 203576

Type: ANDA
Sponsor: MYLAN TEORANTA

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
A203576-001	LEVOLEUCOVORIN CALCIUM	LEVOLEUCOVORIN CALCIUM	EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS			2015-10-20
A203576-002	LEVOLEUCOVORIN CALCIUM	LEVOLEUCOVORIN CALCIUM	EQ 250MG BASE/25ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS			2015-10-20

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 · 88 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
2019-12-13 00:20 UTC	2019-12	A203576-001	LEVOLEUCOVORIN CALCIUM	EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS		2015-10-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203576-002	LEVOLEUCOVORIN CALCIUM	EQ 250MG BASE/25ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS		2015-10-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203576-001	LEVOLEUCOVORIN CALCIUM	EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS		2015-10-20	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203576-002	LEVOLEUCOVORIN CALCIUM	EQ 250MG BASE/25ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS		2015-10-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203576-001	LEVOLEUCOVORIN CALCIUM	EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS		2015-10-20	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203576-002	LEVOLEUCOVORIN CALCIUM	EQ 250MG BASE/25ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS		2015-10-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203576-001	LEVOLEUCOVORIN CALCIUM	EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS		2015-10-20	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203576-002	LEVOLEUCOVORIN CALCIUM	EQ 250MG BASE/25ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS		2015-10-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203576-001	LEVOLEUCOVORIN CALCIUM	EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS		2015-10-20	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A203576-002	LEVOLEUCOVORIN CALCIUM	EQ 250MG BASE/25ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS		2015-10-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203576-001	LEVOLEUCOVORIN CALCIUM	EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS		2015-10-20	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A203576-002	LEVOLEUCOVORIN CALCIUM	EQ 250MG BASE/25ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS		2015-10-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203576-001	LEVOLEUCOVORIN CALCIUM	EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS		2015-10-20	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A203576-002	LEVOLEUCOVORIN CALCIUM	EQ 250MG BASE/25ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS		2015-10-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203576-001	LEVOLEUCOVORIN CALCIUM	EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS		2015-10-20	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A203576-002	LEVOLEUCOVORIN CALCIUM	EQ 250MG BASE/25ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS		2015-10-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203576-001	LEVOLEUCOVORIN CALCIUM	EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS		2015-10-20	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A203576-002	LEVOLEUCOVORIN CALCIUM	EQ 250MG BASE/25ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS		2015-10-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203576-001	LEVOLEUCOVORIN CALCIUM	EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2015-10-20	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A203576-002	LEVOLEUCOVORIN CALCIUM	EQ 250MG BASE/25ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2015-10-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203576-001	LEVOLEUCOVORIN CALCIUM	EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS		2015-10-20	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203576-002	LEVOLEUCOVORIN CALCIUM	EQ 250MG BASE/25ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS		2015-10-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203576-001	LEVOLEUCOVORIN CALCIUM	EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS		2015-10-20	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A203576-002	LEVOLEUCOVORIN CALCIUM	EQ 250MG BASE/25ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS		2015-10-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203576-001	LEVOLEUCOVORIN CALCIUM	EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS		2015-10-20	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A203576-002	LEVOLEUCOVORIN CALCIUM	EQ 250MG BASE/25ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS		2015-10-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203576-001	LEVOLEUCOVORIN CALCIUM	EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS		2015-10-20	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203576-002	LEVOLEUCOVORIN CALCIUM	EQ 250MG BASE/25ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS		2015-10-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203576-001	LEVOLEUCOVORIN CALCIUM	EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS		2015-10-20	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203576-002	LEVOLEUCOVORIN CALCIUM	EQ 250MG BASE/25ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS		2015-10-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203576-001	LEVOLEUCOVORIN CALCIUM	EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS		2015-10-20	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203576-002	LEVOLEUCOVORIN CALCIUM	EQ 250MG BASE/25ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS		2015-10-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203576-001	LEVOLEUCOVORIN CALCIUM	EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS		2015-10-20	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203576-002	LEVOLEUCOVORIN CALCIUM	EQ 250MG BASE/25ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS		2015-10-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203576-001	LEVOLEUCOVORIN CALCIUM	EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS		2015-10-20	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A203576-002	LEVOLEUCOVORIN CALCIUM	EQ 250MG BASE/25ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS		2015-10-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203576-001	LEVOLEUCOVORIN CALCIUM	EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS		2015-10-20	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A203576-002	LEVOLEUCOVORIN CALCIUM	EQ 250MG BASE/25ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS		2015-10-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203576-001	LEVOLEUCOVORIN CALCIUM	EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS		2015-10-20	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203576-002	LEVOLEUCOVORIN CALCIUM	EQ 250MG BASE/25ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS		2015-10-20	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-07-19 19:46 UTC	2019-07	A203576-001	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A203576-002	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 1 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LEVOLEUCOVORIN CALCIUM	LEVOLEUCOVORIN INJECTION	Slate Run Pharmaceuticals	124bc214-62f8-40f9-a227-a35e2d1ff2a0	2023-08-29	Warnings, Adverse reactions	Name fallback brand name: LEVOLEUCOVORIN CALCIUM
Levoleucovorin	LEVOLEUCOVORIN CALCIUM	Meitheal Pharmaceuticals Inc.	059a3306-6207-497f-a947-33198f18761f	2023-08-01	Warnings, Adverse reactions	Name fallback generic name: LEVOLEUCOVORIN CALCIUM
LEVOLEUCOVORIN CALCIUM	LEVOLEUCOVORIN INJECTION	Hainan Poly Pharm. Co., Ltd.	c10b0c18-dd7c-4a76-a79b-b8d38a08ab87	2023-05-31	Warnings, Adverse reactions	Name fallback brand name: LEVOLEUCOVORIN CALCIUM
Levoleucovorin	LEVOLEUCOVORIN CALCIUM	Meitheal Pharmaceuticals Inc	b4dd0e14-d42a-4581-b1f0-7ba95b50bca6	2022-12-06	Warnings, Adverse reactions	Name fallback generic name: LEVOLEUCOVORIN CALCIUM
Levoleucovorin Calcium	LEVOLEUCOVORIN	Amneal Pharmaceuticals LLC	0c67eeae-3090-473d-b712-b9a83dc77b72	2022-11-07	Warnings, Adverse reactions	Name fallback brand name: Levoleucovorin Calcium

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 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
67457-600	LEVOLEUCOVORIN CALCIUM	Levoleucovorin	Mylan Institutional LLC	ANDA	Current
67457-601	LEVOLEUCOVORIN CALCIUM	Levoleucovorin	Mylan Institutional LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
10238	ORIG	2015-10-22