Application 089504

Type: ANDA
Sponsor: QUAD PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LEUCOVORIN CALCIUM	LEUCOVORIN CALCIUM	Injectable; Injection	EQ 5MG BASE/ML	No	No

Source provenance: Browse the complete Orange Book source catalog.

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 2 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	Fresenius Kabi USA, LLC	e3b957dc-a542-4f69-b8a0-7df401ee706f	2022-03-03	Warnings, Adverse reactions	Name fallback brand name: Leucovorin Calcium generic name: LEUCOVORIN CALCIUM
LEUCOVORIN CALCIUM	LEUCOVORIN CALCIUM	Proficient Rx LP	46d12bd0-ec7d-4e2c-aeed-b8aa88e6dc5c	2022-03-01	Warnings, Adverse reactions	Name fallback brand name: LEUCOVORIN CALCIUM generic name: LEUCOVORIN CALCIUM
Leucovorin Calcium	LEUCOVORIN CALCIUM	BluePoint Laboratories	e9b47126-8b52-43ff-85c4-33d32b3d8326	2022-01-19	Warnings, Adverse reactions	Name fallback brand name: Leucovorin Calcium generic name: LEUCOVORIN CALCIUM
Leucovorin Calcium	LEUCOVORIN CALCIUM	Hikma Pharmaceuticals USA Inc.	cc52077f-5663-4f79-a273-0aecf655e038	2021-10-22	Warnings, Adverse reactions	Name fallback brand name: Leucovorin Calcium generic name: LEUCOVORIN CALCIUM

Reported adverse events (FAERS/openFDA)#

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