Bacterial Sinusitis
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Sign up freeTop drugs studied for this disease
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CLINICAL_TRIALS trial_result · 2017-05-02Clinical Trial Update: Comparison Study Between Cefdinir & Amoxicilline/Clavulanate in Acute Sinusitis and Assessment of Quality of Life [Phase 4]
A Phase 4 trial completed at the University of Chicago comparing cefdinir with amoxicillin/clavulanate in acute bacterial sinusitis, includi…
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FDA label_change · 2016-08-23FDA Approved: AMOXICILLIN AND CLAVULANATE POTASSIUM — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for Amoxicillin and clavulanate potassium submitted by Hikma Pharmaceuticals USA Inc., updating the …
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FDA approval · 2016-07-26FDA Approved: MOXIFLOXACIN — Supplemental Application (Fresenius Kabi USA, LLC)
FDA approved a supplemental application for moxifloxacin hydrochloride (MOXIFLOXACIN) from Fresenius Kabi USA, LLC, indicating a modificatio…
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FDA approval · 2016-04-12FDA Approved: CEFUROXIME — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved Hikma Pharmaceuticals USA Inc.'s supplemental application for Cefuroxime, adding an additional approved use/formulation under t…
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FDA approval · 2015-07-01FDA Approved: CLARITHROMYCIN — Supplemental Application (Sandoz Inc)
FDA approved a supplemental application for clarithromycin from Sandoz Inc, indicating continued/expanded approval for generic use of the dr…
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FDA label_change · 2015-03-16FDA Approved: AUGMENTIN ES-600 — Supplemental Application (USAntibiotics, LLC)
FDA approved a supplemental application for AUGMENTIN ES-600 by USAntibiotics, LLC, updating the product labeling.
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FDA approval · 2014-12-21FDA Approved: SULFAMETHOXAZOLE AND TRIMETHOPRIM — Supplemental Application (Amneal Pharmaceuticals of New York LLC)
FDA approved a supplemental application for sulfamethoxazole and trimethoprim from Amneal Pharmaceuticals of New York LLC. The approval cove…
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FDA approval · 2014-11-08FDA Approved: LEVOFLOXACIN — Supplemental Application (Sagent Pharmaceuticals)
The FDA approved a supplemental application for Levofloxacin submitted by Sagent Pharmaceuticals, approving changes to the generic labeling …
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FDA approval · 2014-09-26FDA Approved: AMOXICILLIN AND CLAVULANATE POTASSIUM — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
The FDA approved a supplemental application for Amoxicillin and Clavulanate Potassium from Teva Pharmaceuticals USA, Inc. The supplement rel…
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FDA label_change · 2014-09-22FDA Approved: AMOXICILLIN AND CLAVULANATE POTASSIUM — Supplemental Application (Northstar RxLLC)
The FDA approved a supplemental application for amoxicillin and clavulanate potassium filed by Northstar RxLLC, resulting in a label update …
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FDA approval · 2013-11-22FDA Approved: CEFIXIME — Supplemental Application (Lupin Pharmaceuticals, Inc.)
The FDA approved Lupin Pharmaceuticals' supplemental application for cefixime. This action updates the cefixime NDA, potentially expanding i…
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FDA approval · 2013-06-05FDA Approved: LEVOFLOXACIN — Original Application (Baxter Healthcare Corporation)
FDA approved Baxter Healthcare Corporation's Original Application for levofloxacin (generic), granting clearance for a generic version of th…
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FDA approval · 2012-12-18FDA Approved: AZITHROMYCIN — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved a supplemental application for azithromycin submitted by Teva Pharmaceuticals USA, Inc.
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CLINICAL_TRIALS trial_result · 2012-11-20Clinical Trial Update: Treatment of Patients With Acute Sinusitis
A Bayer-sponsored clinical trial evaluating treatment for acute bacterial sinusitis has completed.
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FDA approval · 2012-07-25FDA Approved: CLARITHROMYCIN — Original Application (Rising Pharma Holdings, Inc.)
FDA approved a generic clarithromycin product under an original ANDA from Rising Pharma Holdings, Inc.
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FDA approval · 2012-03-30FDA Approved: LEVOFLOXACIN — Original Application (Chartwell RX, LLC)
FDA approved an original ANDA for Levofloxacin, a generic antibiotic, submitted by Chartwell RX, LLC. The approval enables a generic version…
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FDA approval · 2012-02-17FDA Approved: CEFACLOR — Original Application (Azorian Pharma, LLC)
The FDA approved Azorian Pharma, LLC's original application for Cefaclor (generic) for treating susceptible bacterial infections including r…
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FDA approval · 2012-01-20FDA Approved: AMOXICILLIN AND CLAVULANATE POTASSIUM — Original Application (Aurobindo Pharma Limited)
FDA approved a generic version of amoxicillin and clavulanate potassium from Aurobindo Pharma Limited under an Original Application (ANDA 09…
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FDA approval · 2012-01-20FDA Approved: AMOXICILLIN AND CLAVULANATE POTASSIUM — Original Application (Aurobindo Pharma Limited)
The FDA approved Aurobindo Pharma Limited's original application for amoxicillin and clavulanate potassium, authorizing the marketing of thi…
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CLINICAL_TRIALS trial_result · 2011-06-10Clinical Trial Update: A Comparison of the Safety and Efficacy of Two Different Regimens of Levofloxacin in the Treatment of Acute Bacterial Sinusitis(Sinus Infection) in Adults. [Phase 3]
A Phase 3 trial compared two regimens of Levofloxacin for acute bacterial sinusitis in adults to assess safety and efficacy. The study has c…
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FDA approval · 2011-01-27FDA Approved: AMOXICILLIN AND CLAVULANATE POTASSIUM — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
The FDA approved a supplemental application for amoxicillin and clavulanate potassium (Hikma Pharmaceuticals USA Inc.), updating the product…
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FDA approval · 2010-12-22FDA Approved: CLARITHROMYCIN — Supplemental Application (Sandoz Inc)
FDA approved a supplemental application for clarithromycin by Sandoz Inc., confirming the approval of a generic clarithromycin product under…
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CLINICAL_TRIALS trial_result · 2010-06-22Clinical Trial Update: The Study of Nasonex® Compared With Placebo for the Relief of Symptoms Associated With Acute Bacterial Sinusitis When Used With Antibiotics (Study P04824AM3) [Phase 3]
Phase 3 trial comparing Nasonex with placebo for relief of symptoms in acute bacterial sinusitis when used with antibiotics; the study was t…
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FDA approval · 2010-02-16FDA Approved: SULFAMETHOXAZOLE AND TRIMETHOPRIM — Original Application (Rising Pharma Holdings, Inc.)
FDA approved Rising Pharma Holdings, Inc.'s generic product Sulfamethoxazole and Trimethoprim as an Original Application (ANDA).
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CLINICAL_TRIALS trial_result · 2009-09-25Clinical Trial Update: CHOOSE : Telithromycin, Acute Bacterial Sinusitis [Phase 4]
The Phase 4 CHOOSE trial evaluating telithromycin for acute bacterial sinusitis has completed.