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Details for New Drug Application (NDA): 071198

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NDA 071198 describes LEUCOVORIN CALCIUM, which is a drug marketed by Par Pharm, Pharmachemie, Xanodyne Pharm, Hospira, Pharmachemie Usa, Eurohlth Intl Sarl, Elkins Sinn, Idt Australia Ltd, Roxane, Abraxis Pharm, Corepharma, Abic, Teva Pharms Usa, Teva Parenteral, Barr, West-ward Pharms Int, Luitpold, Sagent Pharms, and Fresenius Kabi Usa, and is included in thirty-nine NDAs. It is available from eight suppliers. Additional details are available on the LEUCOVORIN CALCIUM profile page.

The generic ingredient in LEUCOVORIN CALCIUM is leucovorin calcium. There are nine drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the leucovorin calcium profile page.

Summary for NDA: 071198

leucovorin calcium

Pharmacology for NDA: 071198

Ingredient-typeFolic Acid

Suppliers and Packaging for NDA: 071198

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
leucovorin calcium
TABLET;ORAL 071198 ANDA Barr Laboratories Inc. 0555-0484 0555-0484-01 30 TABLET in 1 BOTTLE (0555-0484-01)
leucovorin calcium
TABLET;ORAL 071198 ANDA Barr Laboratories Inc. 0555-0484 0555-0484-02 100 TABLET in 1 BOTTLE (0555-0484-02)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE
Approval Date:Sep 24, 1987TE:ABRLD:No

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