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Details for New Drug Application (NDA): 206263

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NDA 206263 describes LEVOLEUCOVORIN CALCIUM, which is a drug marketed by Actavis Llc, Eurohlth Intl Sarl, Sandoz Inc, and Mylan Teoranta, and is included in four NDAs. It is available from three 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. Four suppliers are listed for this compound. Additional details are available on the levoleucovorin calcium profile page.

Summary for NDA: 206263

Eurohlth Intl Sarl
levoleucovorin calcium

Suppliers and Packaging for NDA: 206263

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
levoleucovorin calcium
POWDER;IV (INFUSION) 206263 ANDA West-Ward Pharmaceuticals Corp 0143-9558 0143-9558-01 1 VIAL in 1 BOX (0143-9558-01) > 5 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;IV (INFUSION)StrengthEQ 50MG BASE/VIAL
Approval Date:Jun 16, 2016TE:APRLD:No
Regulatory Exclusivity Expiration:Feb 11, 2017
Regulatory Exclusivity Use:PATENT CHALLENGE

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