Paget Disease of Bone
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Sign up freeTop drugs studied for this disease
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FDA approval · 2015-09-21FDA Approved: ZOLEDRONIC ACID — Supplemental Application (Dr. Reddy's Laboratories Limited)
The FDA approved a supplemental application for zoledronic acid from Dr. Reddy's Laboratories Limited.
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FDA approval · 2015-07-22FDA Approved: ALENDRONATE SODIUM — Supplemental Application (Aurobindo Pharma Limited)
The FDA approved a supplemental application for alendronate sodium filed by Aurobindo Pharma Limited.
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FDA approval · 2015-07-16FDA Approved: ALENDRONATE SODIUM — Supplemental Application (Amneal Pharmaceuticals of New York LLC)
FDA approved a supplemental application for ALENDRONATE SODIUM submitted by Amneal Pharmaceuticals of New York LLC (ANDA075710).
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FDA approval · 2015-04-09FDA Approved: ZOLEDRONIC ACID — Supplemental Application (Dr.Reddy's Laboratories Ltd)
FDA approved a supplemental application for zoledronic acid from Dr. Reddy's Laboratories Ltd (ANDA 091363), granting regulatory approval of…
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FDA approval · 2015-04-08FDA Approved: ACTONEL — Supplemental Application (Allergan, Inc.)
FDA approved a supplemental application for Actonel (risendronate sodium) submitted by Allergan, Inc.
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FDA approval · 2015-04-08FDA Approved: FOSAMAX — Supplemental Application (Organon LLC)
FDA approved a supplemental application for Fosamax (alendronate sodium) submitted by Organon LLC.
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FDA approval · 2015-03-26FDA Approved: ACTONEL — Supplemental Application (Allergan, Inc.)
The FDA approved a supplemental application for Actonel (risedronate sodium) submitted by Allergan, expanding its labeling for additional os…
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FDA approval · 2015-02-02FDA Approved: MIACALCIN — Supplemental Application (Mylan Institutional LLC)
The FDA approved a supplemental application for Miacalcin (calcitonin salmon) submitted by Mylan Institutional LLC.
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FDA approval · 2015-01-30FDA Approved: RECLAST — Supplemental Application (Sandoz Inc)
FDA approved a supplemental application for RECLAST (zoledronic acid) filed by Sandoz Inc., signaling a change to the product's labeling or …
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FDA approval · 2014-06-10FDA Approved: RISEDRONATE SODIUM — Original Application (Apotex Corp.)
FDA approved Apotex Corp.'s original ANDA for risedronate sodium, a generic version of Actonel. The approval covers indications for treating…
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FDA approval · 2013-12-23FDA Approved: FOSAMAX — Supplemental Application (Organon LLC)
The FDA approved a supplemental application for Fosamax (alendronate sodium) submitted by Organon LLC.
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FDA approval · 2013-09-23FDA Approved: ZOLEDRONIC ACID — Original Application (Sagent Pharmaceuticals)
FDA approves a generic zoledronic acid injection from Sagent Pharmaceuticals under ANDA 202828, granting approval to market the product for …
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FDA approval · 2013-07-15FDA Approved: ALENDRONATE SODIUM — Supplemental Application (Amneal Pharmaceuticals of New York LLC)
The FDA approved a supplemental application for alendronate sodium, manufactured by Amneal Pharmaceuticals of New York LLC. This action appr…
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FDA approval · 2013-06-03FDA Approved: ZOLEDRONIC ACID — Original Application (Hikma Pharmaceuticals USA Inc.)
FDA approves Hikma Pharmaceuticals USA Inc.'s original application for a generic zoledronic acid injectable product.
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FDA approval · 2013-04-19FDA Approved: ACTONEL — Supplemental Application (Allergan, Inc.)
FDA approved Allergan's supplemental application for Actonel (risendronate sodium).
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FDA approval · 2013-04-19FDA Approved: BINOSTO — Supplemental Application (Radius Health, Inc.)
The FDA has approved a supplemental application for BINOSTO (alendronate sodium) from Radius Health, Inc. The approval updates the labeling …
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FDA approval · 2013-03-29FDA Approved: ALENDRONATE — Supplemental Application (Hangzhou Minsheng Binjiang Pharmaceutical Co., Ltd.)
FDA approved a supplemental application for alendronate sodium tablets from Hangzhou Minsheng Binjiang Pharmaceutical Co., Ltd.
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FDA approval · 2013-03-29FDA Approved: ZOLEDRONIC ACID — Original Application (Dr.Reddy's Laboratories Ltd)
FDA approved the original application for Zoledronic acid (generic) from Dr. Reddy's Laboratories Ltd. This approval confirms a generic vers…
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FDA approval · 2013-03-04FDA Approved: ZOLEDRONIC ACID — Original Application (Mylan Institutional LLC)
FDA approved an original application for a zoledronic acid generic product manufactured by Mylan Institutional LLC.
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FDA approval · 2013-02-25FDA Approved: ALENDRONATE SODIUM — Original Application (Hikma Pharmaceuticals USA Inc.)
FDA approved Hikma Pharmaceuticals USA Inc.'s generic alendronate sodium tablets under an original ANDA (ANDA 090520). The approval covers o…
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FDA approval · 2013-02-19FDA Approved: MIACALCIN — Supplemental Application (Mylan Institutional LLC)
The FDA approved a supplemental application for Miacalcin (calcitonin salmon) submitted by Mylan Institutional LLC. The action pertains to a…
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FDA approval · 2013-02-05FDA Approved: ALENDRONATE SODIUM — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for a generic alendronate sodium product from Aurobindo Pharma Limited (ANDA 090124). The approval a…
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FDA approval · 2012-07-12FDA Approved: CALCITONIN SALMON — Supplemental Application (Endo USA, Inc.)
FDA approved a supplemental application for Calcitonin Salmon from Endo USA, Inc.
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FDA approval · 2012-06-25FDA Approved: ALENDRONATE SODIUM — Supplemental Application (Aurobindo Pharma Limited)
The FDA approved a supplemental application for alendronate sodium supplied by Aurobindo Pharma Limited under ANDA090124.
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FDA approval · 2012-05-22FDA Approved: ALENDRONATE SODIUM — Supplemental Application (Amneal Pharmaceuticals of New York LLC)
FDA approved a supplemental application for alendronate sodium from Amneal Pharmaceuticals of New York LLC, indicating updated labeling or a…