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Generated: November 20, 2017

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Details for New Drug Application (NDA): 071199

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NDA 071199 describes LEUCOVORIN CALCIUM, which is a drug marketed by Par Pharm, Pharmachemie, Xanodyne Pharm, Hospira, Pharmachemie Usa, West-ward Pharms Int, Elkins Sinn, Idt Australia Ltd, Abraxis Pharm, Epic Pharma Llc, Abic, Teva Pharms Usa, Teva Parenteral, Barr, Mylan Labs Ltd, Luitpold, Sagent Pharms, and Fresenius Kabi Usa, and is included in forty NDAs. It is available from seven 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. Ten suppliers are listed for this compound. Additional details are available on the leucovorin calcium profile page.

Summary for 071199

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 071199

Medical Subject Heading (MeSH) Categories for 071199

Suppliers and Packaging for NDA: 071199

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEUCOVORIN CALCIUM
leucovorin calcium
TABLET;ORAL 071199 ANDA Teva Pharmaceuticals USA, Inc. 0555-0485 0555-0485-04 500 TABLET in 1 BOTTLE (0555-0485-04)
LEUCOVORIN CALCIUM
leucovorin calcium
TABLET;ORAL 071199 ANDA Teva Pharmaceuticals USA, Inc. 0555-0485 0555-0485-27 25 TABLET in 1 BOTTLE (0555-0485-27)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 25MG BASE
Approval Date:Sep 24, 1987TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

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Federal Trade Commission
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Dow
Harvard Business School
Baxter
Julphar

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