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Generated: February 15, 2019

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Details for New Drug Application (NDA): 208723

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NDA 208723 describes LEVOLEUCOVORIN CALCIUM, which is a drug marketed by Actavis Llc, Amneal Pharms Co, West-ward Pharms Int, Gland Pharma Ltd, Ingenus Pharms Llc, Mylan Teoranta, and Sandoz Inc, and is included in nine NDAs. It is available from nine 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. Ten suppliers are listed for this compound. Additional details are available on the levoleucovorin calcium profile page.
Summary for 208723
Applicant:Actavis Llc
Ingredient:levoleucovorin calcium
Medical Subject Heading (MeSH) Categories for 208723
Suppliers and Packaging for NDA: 208723
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEVOLEUCOVORIN CALCIUM levoleucovorin calcium POWDER;INTRAVENOUS 208723 NDA Actavis Pharma, Inc. 0591-4130 0591-4130-54 1 VIAL in 1 CARTON (0591-4130-54) > 17.7 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;INTRAVENOUSStrengthEQ 175MG BASE/VIAL
Approval Date:Sep 29, 2016TE:RLD:Yes

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