Content specific to this active ingredient… Drug Information Prescribing and patient information from leading authorities Drug Master Files Type 2 master files on file at the FDA Safety Information For prescription drugs containing this active ingredient Exclusivity Patent and market exclusivity data Federal Register FR search results for this API FDA Approved Labelling Information found in this drug's package inserts Research Links Chemical identification and research citations Title 21 Code of Federal Regulations FDA regulations for this API

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 ^ FDA's latest approval appears at the bottom of this list. ^                                                                       A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U-Z Health Topics | For Industry | DMF Index | Pharma Job Search | Pharma Company News | Best Phone © 2012 Betterchem.com