Pneumonia
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Sign up freeTop drugs studied for this disease
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FDA approval · 2021-03-16FDA Approved: PIPERACILLIN AND TAZOBACTAM — Supplemental Application (Eugia US LLC)
The FDA approved a supplemental application for Piperacillin and Tazobactam (piperacillin sodium and tazobactam sodium) submitted by Eugia U…
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FDA approval · 2021-02-16FDA Approved: PIPERACILLIN, TAZOBACTAM — Original Application (Sagent Pharmaceuticals)
FDA approves Sagent Pharmaceuticals' generic Piperacillin-tazobactam for intravenous use under Original Application, enabling a generic vers…
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FDA approval · 2019-08-16FDA Approved: MEROPENEM — Original Application (WG Critical Care, LLC)
FDA approved WG Critical Care, LLC's original ANDA for Meropenem, providing a generic version of the carbapenem antibiotic.
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FDA approval · 2019-06-12FDA Approved: VANCOMYCIN HYDROCHLORIDE — Original Application (Slate Run Pharmaceuticals, LLC)
FDA approved the vancomycin hydrochloride original application for Slate Run Pharmaceuticals, enabling a generic version of this antibiotic.
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FDA approval · 2019-05-28FDA Approved: LINEZOLID — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approved a supplemental application for LINEZOLID submitted by Sun Pharmaceutical Industries, Inc. The approval relates to changes to th…
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FDA approval · 2019-02-15FDA Approved: TYZAVAN — Original Application (Hikma Pharmaceuticals USA Inc.)
FDA approved TYZAVAN (vancomycin) from Hikma Pharmaceuticals USA Inc. under an Original Application (NDA211962). This marks the brand’s offi…
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FDA approval · 2018-08-10FDA Approved: PIPERACILLIN AND TAZOBACTAM — Original Application (Shandong Anxin Pharmaceutical Co., Ltd.)
FDA approved the original application for a generic Piperacillin and Tazobactam combination from Shandong Anxin Pharmaceutical Co., Ltd., ex…
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FDA approval · 2018-07-10FDA Approved: VANCOMYCIN HYDROCHLORIDE — Original Application (Mylan Institutional LLC)
FDA approved an Original Application for vancomycin hydrochloride from Mylan Institutional LLC, confirming its use for treating serious infe…
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FDA approval · 2018-05-18FDA Approved: PIPERACILLIN AND TAZOBACTAM — Original Application (Fresenius Kabi USA, LLC)
FDA approves Fresenius Kabi USA, LLC's original generic application for Piperacillin and tazobactam (Piperacillin and tazobactam), authorizi…
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FDA approval · 2018-02-21FDA Approved: VANCOMYCIN HYDROCHLORIDE — Supplemental Application (SAMSON MEDICAL TECHNOLOGIES LLC)
The FDA approved Samson Medical Technologies LLC's supplemental application for vancomycin hydrochloride, a generic antibiotic, under an app…
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FDA approval · 2017-09-27FDA Approved: DOXYCYCLINE HYCLATE — Original Application (Lupin Pharmaceuticals, Inc.)
FDA approved Lupin Pharmaceuticals' doxycycline hyclate generic under an Original Application (ANDA).
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FDA approval · 2017-01-13FDA Approved: PIPERACILLIN AND TAZOBACTAM — Original Application (Provepharm Inc.)
FDA approved a generic combination product of piperacillin and tazobactam (piperacillin sodium and tazobactam sodium) from Provepharm Inc. u…
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FDA approval · 2016-08-04FDA Approved: LINEZOLID — Original Application (Eugia US LLC)
FDA approves a generic version of linezolid (ANDA 206917) for Eugia US LLC, expanding access to this antibiotic.
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FDA approval · 2016-05-12FDA Approved: CLINDAMYCIN PHOSPHATE — Supplemental Application (Padagis Israel Pharmaceuticals Ltd)
FDA approved the supplemental application for clindamycin phosphate (Padagis Israel Pharmaceuticals Ltd), reflecting approval of the supplem…
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FDA approval · 2016-03-31FDA Approved: VANCOMYCIN HYDROCHLORIDE — Original Application (Eugia US LLC)
The FDA approved a generic vancomycin hydrochloride for injection under an original application from Eugia US LLC. This adds a generic IV op…
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FDA approval · 2016-03-15FDA Approved: LINEZOLID — Original Application (Hp Halden Pharma AS)
FDA approved a generic version of the antibiotic linezolid (Hp Halden Pharma AS) under an original ANDA submission.
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FDA approval · 2015-12-21FDA Approved: LINEZOLID — Original Application (Rising Pharma Holdings, Inc.)
FDA approved Rising Pharma Holdings, Inc.'s generic LINEZOLID (linezolid) under an original application (ANDA), enabling market entry of a g…
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FDA approval · 2015-12-07FDA Approved: AMPICILLIN AND SULBACTAM — Original Application (WG Critical Care, LLC)
FDA approved Ampicillin and Sulbactam from WG Critical Care, LLC under an Original Application (ANDA), making a generic antibiotic available…
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FDA approval · 2015-09-28FDA Approved: CLARITHROMYCIN — Original Application (Solaris Pharma Corporation)
FDA approved an Original Application (ANDA) for Clarithromycin from Solaris Pharma Corporation, establishing a generic version of clarithrom…
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FDA approval · 2015-07-16FDA Approved: LINEZOLID — Original Application (Sandoz Inc)
FDA approved Sandoz Inc.'s Original Application (ANDA) for LINEZOLID, enabling a generic linezolid product to be marketed.
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FDA approval · 2015-06-18FDA Approved: LINEZOLID — Original Application (Hospira, Inc.)
FDA approved Hospira's original application for linezolid, an antibiotic indicated for pneumonia and skin and skin structure infections.
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FDA approval · 2015-06-03FDA Approved: LINEZOLID — Original Application (Hikma Pharmaceuticals USA Inc.)
The FDA approves Hikma Pharmaceuticals USA Inc.'s generic LINEZOLID (linezolid) under an Original Abbreviated New Drug Application.
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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 · 2013-05-03FDA Approved: LINEZOLID — Supplemental Application (Mylan Pharmaceuticals Inc.)
FDA approved a supplemental application for LINEZOLID submitted by Mylan Pharmaceuticals Inc. The action reflects an approved modification t…
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FDA approval · 2013-03-29FDA Approved: CEFIXIME — Supplemental Application (Lupin Pharmaceuticals, Inc.)
FDA approved a supplemental application for cefixime from Lupin Pharmaceuticals, Inc. to modify/extend its labeling and/or approval.