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FDA Approval Activities for this Drug…
Leucovorin Calcium Injection Xanodyne Pharmacal, NDA 8-107/S-054 2/12/02 3/7/02 Leucovorin Calcium Injection USP, 10 mg (base)/mL, 300 mg (base)/30 mL, & 500 mg (50 mL) single dose vials, Bedford ANDA 40-347 4/25/00 4/28/00 8/4/03 Leucovorin Calcium for Injection (Preservative-free), 50 mg (base)/vial, Luitpold ANDA 40-338 1/31/01 2/27/01 Leucovorin Calcium for Injection (Preservative-free), 350 mg (base)/vial, Bedford ANDA 40-335 4/20/00 4/24/00 Leucovorin Calcium Injection USP, 10 mg (base)/mL, 500 mg (50 mL) single dose vial Gensia Sicor ANDA 40-332 6/28/99 7/2/99 Leucovorin Calcium for Injection, 500 mg (base)/vial Bigmar, ANDA 40-286 2/26/99 3/2/99 1/17/02 Leucovorin Calcium for Injection, 350 mg (base)/vial. Teva U.S.A., ANDA 40-262 12/15/99 12/27/99 8/4/03 Leucovorin Calcium for Injection, 200 mg (base)/vial Bigmar, ANDA 40-258 2/26/99 3/2/99 Leucovorin Calcium Tablets, 15 mg (base)/vial Invamed ANDA 75-327 LEUCOVORIN CALCIUM Injection 10MG BASE/ML LEUCOVORIN CALCIUM PRESERVATIVE FREE Abbott 089717 LEUCOVORIN CALCIUM Injection 100MG BASE/VIAL LEUCOVORIN CALCIUM Bedford 040347 LEUCOVORIN CALCIUM Injection 10MG BASE/ML LEUCOVORIN CALCIUM PRESERVATIVE FREE Bedford 040056 LEUCOVORIN CALCIUM Injection 200MG BASE/VIAL LEUCOVORIN CALCIUM PRESERVATIVE FREE Bedford 040335 LEUCOVORIN CALCIUM Injection 350MG BASE/VIAL LEUCOVORIN CALCIUM PRESERVATIVE FREE Bedford 089384 LEUCOVORIN CALCIUM Injection 50MG BASE/VIAL LEUCOVORIN CALCIUM Bedford 040258 LEUCOVORIN CALCIUM Injection 200MG BASE/VIAL LEUCOVORIN CALCIUM PRESERVATIVE FREE BIGMAR 040286 LEUCOVORIN CALCIUM Injection 500MG BASE/VIAL LEUCOVORIN CALCIUM PRESERVATIVE FREE BIGMAR 081277 LEUCOVORIN CALCIUM Injection 100MG BASE/VIAL LEUCOVORIN CALCIUM Gensia Sicor 040332 LEUCOVORIN CALCIUM Injection 10MG BASE/ML LEUCOVORIN CALCIUM PRESERVATIVE FREE Gensia Sicor 040174 LEUCOVORIN CALCIUM Injection 350MG BASE/VIAL LEUCOVORIN CALCIUM Gensia Sicor 081278 LEUCOVORIN CALCIUM Injection 50MG BASE/VIAL LEUCOVORIN CALCIUM Gensia Sicor 087439 LEUCOVORIN CALCIUM Injection 5MG BASE/ML WELLCOVORIN GLAXOSMITHKLINE 040338 LEUCOVORIN CALCIUM Injection 50MG BASE/VIAL LEUCOVORIN CALCIUM PRESERVATIVE FREE LUITPOLD 040262 LEUCOVORIN CALCIUM Injection 350MG BASE/VIAL LEUCOVORIN CALCIUM Pharmachemie 089915 LEUCOVORIN CALCIUM Injection 100MG BASE/VIAL LEUCOVORIN CALCIUM Pharmachemie USA 089628 LEUCOVORIN CALCIUM Injection 50MG BASE/VIAL LEUCOVORIN CALCIUM Pharmachemie USA 008107 LEUCOVORIN CALCIUM Injection 100MG BASE/VIAL LEUCOVORIN CALCIUM XANODYNE 008107 LEUCOVORIN CALCIUM Injection 350MG BASE/VIAL LEUCOVORIN CALCIUM XANODYNE 008107 LEUCOVORIN CALCIUM Injection 50MG BASE/VIAL LEUCOVORIN CALCIUM XANODYNE 071199 LEUCOVORIN CALCIUM Tablet; 25MG BASE LEUCOVORIN CALCIUM Barr 071198 LEUCOVORIN CALCIUM Tablet; 5MG BASE LEUCOVORIN CALCIUM Barr 075327 LEUCOVORIN CALCIUM Tablet; 15MG BASE LEUCOVORIN CALCIUM Geneva TECH 074544 LEUCOVORIN CALCIUM Tablet; 25MG BASE LEUCOVORIN CALCIUM Par 074544 LEUCOVORIN CALCIUM Tablet; 5MG BASE LEUCOVORIN CALCIUM Par 073101 LEUCOVORIN CALCIUM Tablet; 25MG BASE LEUCOVORIN CALCIUM Pharmachemie 073099 LEUCOVORIN CALCIUM Tablet; 5MG BASE LEUCOVORIN CALCIUM Pharmachemie 072734 LEUCOVORIN CALCIUM Tablet; 10MG BASE LEUCOVORIN CALCIUM Roxane 072735 LEUCOVORIN CALCIUM Tablet; 15MG BASE LEUCOVORIN CALCIUM Roxane 072736 LEUCOVORIN CALCIUM Tablet; 25MG BASE LEUCOVORIN CALCIUM Roxane 072733 LEUCOVORIN CALCIUM Tablet; 5MG BASE LEUCOVORIN CALCIUM Roxane 071962 LEUCOVORIN CALCIUM Tablet; 10MG BASE LEUCOVORIN CALCIUM XANODYNE 071104 LEUCOVORIN CALCIUM Tablet; 15MG BASE LEUCOVORIN CALCIUM XANODYNE 018459 BX LEUCOVORIN CALCIUM Tablet; 5MG BASE LEUCOVORIN CALCIUM XANODYNE Leucovorin Calcium Injection, Mayne
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