Pharyngitis

• 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 · 2024-04-09
  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 · 2023-08-16
  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 · 2022-01-31
  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 · 2022-01-12
  FDA Approved: AZITHROMYCIN — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for AZITHROMYCIN submitted by Aurobindo Pharma Limited under an ANDA.

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• FDA approval · 2021-02-19
  FDA Approved: CEFDINIR — Original Application (American Health Packaging)

  FDA approves the original ANDA for cefdinir (CEFDINIR) by American Health Packaging, making a generic cefdinir product available.

• 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 · 2020-05-01
  FDA Approved: AZITHROMYCIN DIHYDRATE — Supplemental Application (Precision Dose, Inc.)

  FDA approved a supplemental application for azithromycin dihydrate submitted by Precision Dose, Inc.

• 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 · 2020-03-09
  FDA Approved: CEFDINIR — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for CEFDINIR (cefdinir) from Aurobindo Pharma Limited, a generic cephalosporin antibiotic.

• FDA approval · 2020-02-11
  FDA Approved: CEFDINIR — Supplemental Application (Sandoz Inc)

  The FDA approved a supplemental application for CEFDINIR (cefdinir) submitted by Sandoz Inc.

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

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

• 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 · 2017-05-15
  FDA Approved: CEFPROZIL — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental application for Cefprozil submitted by Rising Pharma Holdings, Inc., resulting in an updated labeling for the pr…

• FDA approval · 2015-07-27
  FDA Approved: CLARITHROMYCIN — Supplemental Application (Chartwell RX, LLC.)

  FDA approved Chartwell RX, LLC.'s supplemental application for Clarithromycin (generic) under the ANDA process, resulting in approval of a g…

• FDA approval · 2015-07-01
  FDA 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…

• FDA approval · 2013-11-22
  FDA 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…

• FDA approval · 2013-04-25
  FDA Approved: CEFADROXIL — Original Application (Rising Pharma Holdings, Inc.)

  FDA approved the original application for a generic cefadroxil product from Rising Pharma Holdings, Inc. (ANDA065349).

• FDA approval · 2013-03-29
  FDA 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.

• FDA approval · 2012-12-18
  FDA Approved: AZITHROMYCIN — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for azithromycin submitted by Teva Pharmaceuticals USA, Inc.

• FDA approval · 2012-07-25
  FDA Approved: CLARITHROMYCIN — Original Application (Rising Pharma Holdings, Inc.)

  FDA approved a generic clarithromycin product under an original ANDA from Rising Pharma Holdings, Inc.

• FDA approval · 2012-06-01
  FDA Approved: CEFIXIME — Original Application (Lupin Pharmaceuticals, Inc.)

  The FDA approved Lupin Pharmaceuticals' cefixime product under NDA203195 as a generic oral cephalosporin antibiotic.

• FDA approval · 2010-12-20
  FDA Approved: CEPHALEXIN — Original Application (AvPAK)

  FDA approved the original application for Cephalexin (generic) from AvPAK under ANDA090836.