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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 211132


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NDA 211132 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 211132
Tradename:LEUCOVORIN CALCIUM
Applicant:Novast Labs
Ingredient:leucovorin calcium
Patents:0
Pharmacology for NDA: 211132
Medical Subject Heading (MeSH) Categories for 211132
Suppliers and Packaging for NDA: 211132
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEUCOVORIN CALCIUM leucovorin calcium TABLET;ORAL 211132 ANDA Ingenus Pharmaceuticals, LLC 50742-181 50742-181-01 100 TABLET in 1 BOTTLE (50742-181-01)
LEUCOVORIN CALCIUM leucovorin calcium TABLET;ORAL 211132 ANDA Ingenus Pharmaceuticals, LLC 50742-181 50742-181-30 30 TABLET in 1 BOTTLE (50742-181-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE
Approval Date:Jul 30, 2020TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Jul 30, 2020TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 15MG BASE
Approval Date:Jul 30, 2020TE:ABRLD:No

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