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Details for New Drug Application (NDA): 203576

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NDA 203576 describes LEVOLEUCOVORIN CALCIUM, which is a drug marketed by Actavis Llc, West-ward Pharms Int, Sandoz Inc, and Mylan Teoranta, and is included in four NDAs. It is available from four 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. Five suppliers are listed for this compound. Additional details are available on the levoleucovorin calcium profile page.

Summary for NDA: 203576

Tradename:
LEVOLEUCOVORIN CALCIUM
Applicant:
Mylan Teoranta
Ingredient:
levoleucovorin calcium
Patents:0

Suppliers and Packaging for NDA: 203576

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEVOLEUCOVORIN CALCIUM
levoleucovorin calcium
SOLUTION;IV (INFUSION) 203576 ANDA Mylan Institutional LLC 67457-600 67457-600-20 1 VIAL, SINGLE-DOSE in 1 CARTON (67457-600-20) > 17.5 mL in 1 VIAL, SINGLE-DOSE
LEVOLEUCOVORIN CALCIUM
levoleucovorin calcium
SOLUTION;IV (INFUSION) 203576 ANDA Mylan Institutional LLC 67457-601 67457-601-30 1 VIAL, SINGLE-DOSE in 1 CARTON (67457-601-30) > 25 mL in 1 VIAL, SINGLE-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;IV (INFUSION)StrengthEQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)
Approval Date:Oct 20, 2015TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;IV (INFUSION)StrengthEQ 250MG BASE/25ML (EQ 10MG BASE/ML)
Approval Date:Oct 20, 2015TE:APRLD:No


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