Sinusitis

• 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 · 2017-03-24
  FDA Approved: ADVIL SINUS CONGESTION AND PAIN — Supplemental Application (Haleon US Holdings LLC)

  The FDA approved a supplemental application to market Advil Sinus Congestion and Pain, a combination ibuprofen and phenylephrine product fro…

• FDA approval · 2017-03-23
  FDA Approved: ADVIL COLD AND SINUS — Supplemental Application (Haleon US Holdings LLC)

  FDA approved a supplemental application for Advil Cold and Sinus, a combination product of ibuprofen and pseudoephedrine hydrochloride. The …

• FDA approval · 2015-09-28
  FDA 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…

• 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…

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA approval · 2015-03-30
  FDA Approved: ADVIL SINUS CONGESTION AND PAIN — Supplemental Application (Haleon US Holdings LLC)

  FDA approved a supplemental application for Advil Sinus Congestion and Pain, a combination product containing ibuprofen and phenylephrine hy…

• FDA approval · 2014-07-03
  FDA Approved: EQUALINE CONGESTION RELIEF — Original Application (United Natural Foods, Inc. dba UNFI)

  FDA approved Equaline Congestion Relief, a generic combination of ibuprofen and phenylephrine hydrochloride. It is intended for temporary re…

• FDA approval · 2014-03-05
  FDA Approved: CIPROFLOXACIN — Original Application (Chartwell RX, LLC)

  FDA approved the original application for ciprofloxacin (generic) by Chartwell RX, LLC.

• 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 · 2011-03-14
  FDA Approved: ADVIL COLD AND SINUS — Supplemental Application (Haleon US Holdings LLC)

  FDA approved a supplemental application for Advil Cold and Sinus from Haleon US Holdings LLC.

• FDA approval · 2011-02-07
  FDA Approved: SINUS AND COLD D — Supplemental Application (Meijer Distribution Inc)

  The FDA approved a supplemental application for SINUS AND COLD D, a naproxen sodium and pseudoephedrine hydrochloride product from Meijer Di…

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

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

• FDA approval · 2010-09-02
  FDA Approved: ADVIL COLD AND SINUS — Supplemental Application (Haleon US Holdings LLC)

  FDA supplemental application for Advil Cold and Sinus (ibuprofen and pseudoephedrine hydrochloride) submitted by Haleon US Holdings LLC. The…

• FDA approval · 2010-08-31
  FDA Approved: ADVIL ALLERGY SINUS — Supplemental Application (Haleon US Holdings LLC)

  FDA approved a supplemental application for Advil Allergy Sinus (chlorpheniramine maleate, ibuprofen, and pseudoephedrine HCl) from Haleon U…

• FDA approval · 2010-06-07
  FDA Approved: CEFUROXIME AXETIL — Original Application (Golden State Medical Supply, Inc.)

  FDA approved an original application for cefuroxime axetil from Golden State Medical Supply, Inc. for use as an oral antibiotic (ANDA).

• FDA approval · 2010-05-27
  FDA Approved: ADVIL SINUS CONGESTION AND PAIN — Original Application (Haleon US Holdings LLC)

  FDA approves Advil Sinus Congestion and Pain as an original application, combining ibuprofen with phenylephrine hydrochloride to provide tem…

• FDA approval · 2009-05-19
  FDA Approved: ADVIL COLD AND SINUS — Supplemental Application (Haleon US Holdings LLC)

  FDA approved a supplemental application for Advil Cold and Sinus (ibuprofen and pseudoephedrine hydrochloride) from Haleon US Holdings LLC.

• FDA approval · 2009-05-19
  FDA Approved: ADVIL ALLERGY SINUS — Supplemental Application (Haleon US Holdings LLC)

  The FDA approved a supplemental application for Advil Allergy Sinus, a multi-ingredient combination product from Haleon US Holdings LLC.

• FDA approval · 2009-05-19
  FDA Approved: ADVIL COLD AND SINUS — Supplemental Application (Haleon US Holdings LLC)

  The FDA approved a supplemental application for Advil Cold and Sinus, incorporating ibuprofen with pseudoephedrine hydrochloride to expand l…

• FDA approval · 2009-02-02
  FDA Approved: AMOXICILLIN — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for amoxicillin from Teva Pharmaceuticals USA, Inc., resulting in updated labeling and specification…

• FDA approval · 2008-09-23
  FDA Approved: SINUS AND COLD D — Supplemental Application (Meijer Distribution Inc)

  FDA approved a supplemental application for Sinus and Cold D, a naproxen sodium and pseudoephedrine hydrochloride combination, distributed b…

• FDA approval · 2008-06-11
  FDA Approved: CEFDINIR — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved a supplemental application for CEFDINIR (cefdinir) from Lupin Pharmaceuticals, indicating an expanded approval for this antibio…

• FDA approval · 2008-03-10
  FDA Approved: CEFPROZIL — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for Cefprozil from Teva Pharmaceuticals USA, Inc., updating labeling or indications for the anti…

• FDA approval · 2008-01-16
  FDA Approved: CEFPROZIL — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved a supplemental application for cefprozil from Lupin Pharmaceuticals, Inc., resulting in updated labeling under the supplemental…

• FDA approval · 2008-01-07
  FDA Approved: CEFDINIR — Original Application (BluePoint Laboratories)

  FDA approves an Abbreviated New Drug Application for cefdinir from BluePoint Laboratories, indicating the availability of a generic cefdinir…