FDA Approval Activities for this Drug…

Milrinone Lactate Injection, 0.2 mg (base)/mL, 100 mL plastic containers, ESI Lederle ANDA 76-259 8/8/02 Milrinone Lactate Injection, 1 mg/mL, 10 mL & 20 mL single dose vials, International Medication Systems, Ltd. ANDA 76-013 8/2/02 Milrinone Lactate Injection, 1 mg (base)/mL, American Pharmaceutical Partners, ANDA 75-936 5/28/02 Milrinone Lactate Injection, 1 mg (base)/mL, 10 mL, 20 mL & 50 mL, American Pharmaceutical Partners, ANDA 75-936 10/17/01 4/16/03 Milrinone Lactate Injection, 0.2 mg (base)/mL, 100 mL & 200 mL, Abbott ANDA 75-885 5/28/02 Milrinone Lactate Injection, 1 mg (base)/mL, Abbott ANDA 75-884 5/28/02 Milrinone Lactate Injection, 1 mg (base)/mL, 10 mL, 20 mL & 50 mL, Baxter Healthcare ANDA 75-852 5/28/02 Milrinone Lactate Injection, 1 mg (base)/mL, 10 mL, 20 mL & 50 mL, Baxter Pharmaceutical Products, ANDA 75-852 8/2/01 Milrinone Lactate Injection, 0.2 mg (base)/mL, Baxter Healthcare ANDA 75-834 5/28/02 Milrinone Lactate in 5% Dextrose Injection, 0.2 mg (base)/100 & 200 mL, Baxter Healthcare ANDA 75-834 10/30/01 Milrinone Lactate Injection, 1 mg (base)/mL, 10 mL, 20, & 50 mL, Faulding Pharmaceutical Company ANDA 75-830 5/28/02 Milrinone Lactate Injection, 1 mg (base)/mL, 10 mL, 20, & 50 mL, 11/9/01 Faulding Pharmaceutical Company ANDA 75-830 11/9/01 4/15/03 Milrinone Lactate Injection, 1 mg (base)/mL, 10, 20 & 50 mL, Bedford ANDA 75-660 5/28/02 Milrinone Lactate Injection, 1 mg (base)/1 mL, Bedford ANDA 75-660 4/30/02 Milrinone Lactate Injection, 1 mg (base)/mL, ESI Lederle ANDA 75-530 5/28/02 Milrinone Lactate Injection,1 mg (base)/mL, 10 mL and 20 mL, 5/18/00 ESI Lederle ANDA 75-530 5/18/00 5/22/00 Milrinone Lactate in 5% Dextrose Injection, 0.2 mg(base)/mL, ESI Lederle ANDA 75-510 5/28/02 Milrinone Lactate in 5% Dextrose Injection, 20 mg (base)/100 mL, d 4/25/00 ESI Lederle ANDA 75-510 4/25/00 4/28/00 Milrinone Lactate in 5% Dextrose Injection, 20 mg (base)/100 mL, Second 12/28/01 ESI Lederle ANDA 75-510 Primacor (milrinone lactate) Injection & Primacor (milrinone lactate) in 5% Dextrose Injection Sanofi-Synthelabo NDA 19-436/S-019 MILRINONE LACTATE Injection 1MG BASE/ML MILRINONE LACTATE Abbott 075885 MILRINONE LACTATE Injection 20MG BASE/100ML MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER Abbott 075936 MILRINONE LACTATE Injection 1MG BASE/ML MILRINONE LACTATE AM PARTNERS 075530 MILRINONE LACTATE Injection 1MG BASE/ML MILRINONE LACTATE Baxter 076259 MILRINONE LACTATE Injection 20MG BASE/100ML MILRINONE LACTOSE IN 5% DEXTROSE Baxter 075834 MILRINONE LACTATE Injection 20MG BASE/100ML MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER Baxter 075510 MILRINONE LACTATE Injection 20MG BASE/100ML MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER Baxter 075852 MILRINONE LACTATE Injection 1MG BASE/ML MILRINONE LACTATE Baxter CORP 075660 MILRINONE LACTATE Injection 10MG /10ML(10MG/ML) MILRINONE LACTATE Bedford 076428 MILRINONE LACTATE Injection 1MG BASE/ML MILRINONE LACTATE Bioniche (CANADA) 075830 MILRINONE LACTATE Injection 1MG BASE/ML MILRINONE LACTATE Faulding 076013 MILRINONE LACTATE Injection 1MG BASE/ML MILRINONE LACTATE INTL MEDICATED 019436 MILRINONE LACTATE Injection 1MG BASE/ML PRIMACOR SANOFI SYNTHELABO 020343 MILRINONE LACTATE Injection 20MG BASE/100ML PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER SANOFI SYNTHELABO NDA 20-343/S-014 Milrinone Lactate Injection, B. Braun, Approval | Milrinone Lactate Injection, Apotex Corp., Approval

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