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FDA Approval Activities for this Drug…
Zometa (zoledronic acid) Injection, Novartis NDA 21-223/S004 3/7/03 3/26/03 3/26/03 | Zometa (zoledronic acid) Injection, Novartis NDA 21-386 NDA 21-223/S003 2/22/02 3/7/02 2/22/02 7/5/02 | Zometa (zoledronic acid) Injection Novartis NDA 21-223 Zometa (zoledronic acid) Injection, Novartis Pharmaceuticals | Zometa (zoledronic acid) Injection, Novartis Pharmaceuticals Corporation | Zometa (zoledronic acid) Injection, Novartis, Labeling Revision | Zometa (zoledronic acid injection), Novartis Pharma, Labeling Revision | Zometa (zoledronic acid injection), Novartis Pharma, Labeling Revision | Reclast (zoledronic acid) Injection, Novartis Pharma, Approval | Reclast (zoledronic acid) Injection, Novartis Pharma, Approval | Zometa (zoledronic acid) Injection, Novartis Pharma, Labeling Revision | Zometa (zoledronic acid) Injection, Novartis Pharma, Patient Population Altered | Reclast (zoledronic acid) Injection, Novartis Pharmaceuticals Corp., New or Modified Indication | Reclast (zoledronic acid) I.V. Injection, Novartis Pharmaceuticals Corp., New or Modified Indication | Reclast (zoledronic acid) I.V. Injection , Novartis Pharmaceuticals Corp., New or Modified Indication | Zoledronic Acid I.V. Injection, Apotex, Inc., Tentative Approval | Zoledronic Acid Injection, PharmaForce, Inc., Tentative Approval | Zoledronic Acid Injection, Teva Parenteral Medicines, Inc., Tentative Approval | Zoledronic Acid Injection, Sun Pharma Global, Inc., Tentative Approval | Zoledronic Acid Injection, Bedford Laboratories, Tentative Approval | Zometa (zoledronic acid) Infusion, Novartis, Labeling Revision | Zoledronic Acid Injection, Hospira, Inc., Tentative Approval | Zoledronic Acid Injection, Hospira, Inc., Tentative Approval | Zoledronic Acid Injection, Pharmaceutics International Inc., Tentative Approval | Reclast (zoledronic acid) I.V. Injection, Novartis Pharmaceuticals Corporation, Labeling Revision | Zometa (zoledronic acid) I.V. Injection, Novartis Pharmaceuticals, Inc., Labeling Revision | Reclast (zoledronic acid) Injection, Novartis Pharmaceuticals Corp., Labeling Revision | Zoledronic Acid Injection, Emcure Pharmaceuticals USA Inc., Tentative Approval | Reclast (zoledronic acid) I.V. Injection, Novartis Pharmaceuticals Corp., Labeling Revision | Reclast (zoledronic acid) Injection, Novartis Pharmaceuticals Corp., Labeling Revision | Zoledronic Acid Injection, Dr. Reddy’s Laboratories, Ltd., Tentative Approval | Zoledronic Acid Injection, Dr. Reddy’s Laboratories Ltd., Tentative Approval | Zoledronic Acid Injection, Dr. Reddy’s Laboratories Ltd., Tentative Approval
  
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