Details for New Drug Application (NDA): 207241

NDA 207241 describes LEUCOVORIN CALCIUM, which is a drug marketed by Hospira, Abic, Abraxis Pharm, Elkins Sinn, Hainan Poly, Hikma, Meitheal, Pharmachemie, Pharmachemie Usa, Teva Parenteral, Teva Pharms Usa, Fresenius Kabi Usa, Novast Labs, Ani Pharms, Barr, Epic Pharma Llc, Leading, Par Pharm, Xanodyne Pharm, Am Regent, Mylan Labs Ltd, Sagent Pharms, and Sagent Pharms Inc, and is included in forty-eight NDAs. It is available from twelve suppliers. Additional details are available on the LEUCOVORIN CALCIUM profile page.

The generic ingredient in LEUCOVORIN CALCIUM is leucovorin calcium. There are nine drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the leucovorin calcium profile page.

Summary for 207241

Tradename:	LEUCOVORIN CALCIUM
Applicant:	Fresenius Kabi Usa
Ingredient:	leucovorin calcium
Patents:	0

Pharmacology for NDA: 207241

Medical Subject Heading (MeSH) Categories for 207241

Antidotes

Vitamin B Complex

Suppliers and Packaging for NDA: 207241

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LEUCOVORIN CALCIUM	leucovorin calcium	SOLUTION;INTRAMUSCULAR, INTRAVENOUS	207241	ANDA	Fresenius Kabi USA, LLC	63323-631	63323-631-50	1 VIAL, SINGLE-USE in 1 CARTON (63323-631-50) / 50 mL in 1 VIAL, SINGLE-USE
LEUCOVORIN CALCIUM	leucovorin calcium	SOLUTION;INTRAMUSCULAR, INTRAVENOUS	207241	ANDA	Fresenius Kabi USA, LLC	63323-631	63323-631-10	1 VIAL, SINGLE-USE in 1 CARTON (63323-631-10) / 10 mL in 1 VIAL, SINGLE-USE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAMUSCULAR, INTRAVENOUS			Strength	EQ 100MG BASE/10ML (EQ 10MG BASE/ML)
Approval Date:	Mar 14, 2018	TE:		RLD:	No

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