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Last Updated: December 7, 2019

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Details for New Drug Application (NDA): 207548

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NDA 207548 describes LEVOLEUCOVORIN CALCIUM, which is a drug marketed by Actavis Llc, Amneal Pharms Co, Nanjing King-friend, West-ward Pharms Int, Gland Pharma Ltd, Ingenus Pharms Llc, Mylan Teoranta, and Sandoz Inc, and is included in eleven NDAs. It is available from ten 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. Eleven suppliers are listed for this compound. Additional details are available on the levoleucovorin calcium profile page.
Summary for 207548
Applicant:Amneal Pharms Co
Ingredient:levoleucovorin calcium
Pharmacology for NDA: 207548
Medical Subject Heading (MeSH) Categories for 207548
Suppliers and Packaging for NDA: 207548
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEVOLEUCOVORIN CALCIUM levoleucovorin calcium SOLUTION;INTRAVENOUS 207548 ANDA Amneal Biosciences LLC 70121-1572 70121-1572-1 1 VIAL in 1 CARTON (70121-1572-1) > 17.5 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrengthEQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)
Approval Date:Sep 8, 2017TE:APRLD:No

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