Bacterial Sinusitis

• FDA approval · 2024-12-04
  FDA Approved: DOXYCYCLINE — Original Application (Amneal Pharmaceuticals LLC)

  FDA approved Amneal Pharmaceuticals LLC's generic doxycycline as an original ANDA product.

• FDA approval · 2024-06-24
  FDA Approved: AMOXICILLIN AND CLAVULANATE POTASSIUM — Supplemental Application (Sandoz Inc)

  The FDA approved a supplemental application for Amoxicillin and Clavulanate Potassium by Sandoz Inc to support changes to the approved gener…

• FDA approval · 2024-05-01
  FDA Approved: AMOXICILLIN AND CLAVULANATE POTASSIUM — Supplemental Application (Northstar RxLLC)

  FDA approved a supplemental application for Amoxicillin and clavulanate potassium (amoxicillin-clavulanate) from Northstar RxLLC, authorizin…

• FDA approval · 2024-04-25
  FDA Approved: AMOXICILLIN — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for amoxicillin submitted by Hikma Pharmaceuticals USA Inc.

• FDA approval · 2024-04-24
  FDA 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.

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• FDA approval · 2024-04-09
  FDA Approved: CEFPROZIL — Original Application (Ascend Laboratories, LLC)

  FDA approved the original application for cefprozil from Ascend Laboratories, LLC, confirming it as a generic cephalosporin antibiotic.

• FDA approval · 2023-12-11
  FDA Approved: AMOXICILLIN AND CLAVULANATE POTASSIUM — Original Application (Devatis, Inc.)

  FDA approved an Original Application for amoxicillin and clavulanate potassium (amoxicillin/clavulanate) as a generic antibiotic formulation…

• FDA approval · 2023-09-15
  FDA Approved: AMOXICILLIN AND CLAVULANATE POTASSIUM — Original Application (Devatis, Inc.)

  FDA approves a generic amoxicillin/clavulanate potassium product under an Original Application by Devatis, Inc.

• FDA approval · 2023-09-13
  FDA Approved: AMOXICILLIN AND CLAVULANATE POTASSIUM — Original Application (Devatis Inc.)

  FDA approved a generic Amoxicillin and clavulanate potassium product under Original Application by Devatis Inc.

• FDA approval · 2023-08-16
  FDA Approved: CLARITHROMYCIN — Supplemental Application (Sandoz Inc)

  FDA approved Sandoz Inc's supplemental application for clarithromycin, marking a supplemental approval for this generic antibiotic. The acti…

• FDA approval · 2023-08-16
  FDA Approved: CLARITHROMYCIN — Supplemental Application (Lannett Company, Inc.)

  FDA approved a supplemental application for a generic version of clarithromycin produced by Lannett Company, Inc.

• FDA approval · 2022-11-02
  FDA Approved: AMOXICILLIN AND CLAVULANATE POTASSIUM — Supplemental Application (USAntibiotics, LLC)

  FDA approved a supplemental application for Amoxicillin and Clavulanate Potassium submitted by USAntibiotics, LLC.

• FDA approval · 2022-01-31
  FDA Approved: CLARITHROMYCIN — Original Application (Alembic Pharmaceuticals Inc.)

  FDA approved Alembic Pharmaceuticals' generic clarithromycin under Original Application ANDA210459. This expands access to clarithromycin as…

• FDA approval · 2020-06-03
  FDA Approved: AMOXICILLIN — Supplemental Application (Sandoz Inc)

  The FDA approved a supplemental application for amoxicillin submitted by Sandoz Inc.

• FDA approval · 2020-05-01
  FDA Approved: AZITHROMYCIN — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved a supplemental application for AZITHROMYCIN from Lupin Pharmaceuticals, Inc., signaling an update to the product's regulatory a…

• FDA approval · 2020-04-22
  FDA Approved: LEVOFLOXACIN — Original Application (Gland Pharma Limited)

  FDA approved an original application for levofloxacin from Gland Pharma Limited, authorizing a generic version of the antibiotic.

• FDA approval · 2020-03-09
  FDA Approved: CEFDINIR — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for Cefdinir from Teva Pharmaceuticals USA, Inc., resulting in labeling updates for the product.

• FDA approval · 2020-01-28
  FDA Approved: AZITHROMYCIN — Original Application (Alembic Pharmaceuticals Limited)

  FDA approves Alembic Pharmaceuticals' original application for AZITHROMYCIN, granting a generic azithromycin product for the same indication…

• FDA approval · 2020-01-27
  FDA Approved: AMOXICILLIN AND CLAVULANATE POTASSIUM — Supplemental Application (Sandoz Inc)

  The FDA approved a supplemental application for Amoxicillin and clavulanate potassium by Sandoz Inc.

• FDA approval · 2020-01-23
  FDA Approved: AZITHROMYCIN — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for azithromycin filed by Aurobindo Pharma Limited.

• FDA approval · 2019-04-19
  FDA Approved: AMOXICILLIN AND CLAVULANATE POTASSIUM — Original Application (Aurobindo Pharma Limited)

  FDA approved the Original Application for Amoxicillin and clavulanate potassium from Aurobindo Pharma Limited, a generic antibiotic product.

• FDA approval · 2018-12-07
  FDA Approved: AZITHROMYCIN — Original Application (Lannett Company, Inc.)

  FDA approves Lannett Company, Inc.'s original application for azithromycin (AZITHROMYCIN), a generic antibiotic.

• FDA approval · 2018-09-24
  FDA Approved: AZITHROMYCIN DIHYDRATE — Original Application (Precision Dose, Inc.)

  FDA approved azithromycin dihydrate as a generic drug under Original Application by Precision Dose, Inc., expanding access to this antibioti…

• FDA approval · 2018-07-05
  FDA Approved: AZITHROMYCIN — Original Application (Aurobindo Pharma Limited)

  FDA approved a generic azithromycin product under an Original ANDA for Aurobindo Pharma Limited.

• FDA approval · 2016-07-26
  FDA 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…