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Chubb
Harvard Business School
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Federal Trade Commission
Teva
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UBS
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Generated: April 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203563

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NDA 203563 describes LEVOLEUCOVORIN CALCIUM, which is a drug marketed by Actavis Llc, Amneal Pharms Co, West-ward Pharms Int, Mylan Teoranta, and Sandoz Inc, and is included in seven NDAs. It is available from five suppliers. Additional details are available on the LEVOLEUCOVORIN CALCIUM profile page.

The generic ingredient in LEVOLEUCOVORIN CALCIUM is levoleucovorin calcium. There is one drug master file entry for this compound. Six suppliers are listed for this compound. Additional details are available on the levoleucovorin calcium profile page.
Summary for 203563
Tradename:LEVOLEUCOVORIN CALCIUM
Applicant:Sandoz Inc
Ingredient:levoleucovorin calcium
Patents:0
Medical Subject Heading (MeSH) Categories for 203563
Suppliers and Packaging for NDA: 203563
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEVOLEUCOVORIN CALCIUM levoleucovorin calcium SOLUTION;IV (INFUSION) 203563 ANDA Sandoz Inc 0781-3201 N 0781-3201-94

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;IV (INFUSION)StrengthEQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)
Approval Date:Mar 9, 2015TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;IV (INFUSION)StrengthEQ 250MG BASE/25ML (EQ 10MG BASE/ML)
Approval Date:Mar 9, 2015TE:APRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
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