Allergic Rhinitis

• FDA approval · 2014-05-16
  FDA Approved: CHILDRENS ZYRTEC — Supplemental Application (Kenvue Brands LLC)

  FDA approved a supplemental application for CHILDRENS ZYRTEC (cetirizine hydrochloride) submitted by Kenvue Brands LLC.

• FDA approval · 2014-05-15
  FDA Approved: CLARITIN ALLERGY — Supplemental Application (Bayer HealthCare LLC.)

  FDA approved a supplemental application for Claritin Allergy (loratadine) by Bayer HealthCare LLC. The filing relates to labeling and/or ind…

• FDA approval · 2014-05-14
  FDA Approved: ALLEGRA-D ALLERGY AND CONGESTION — Supplemental Application (Chattem, Inc.)

  The FDA approved a supplemental application for Allegra-D Allergy and Congestion, a combination of fexofenadine hydrochloride and pseudoephe…

• FDA approval · 2014-05-12
  FDA Approved: DESLORATADINE — Supplemental Application (Virtus Pharmaceuticals, LLC)

  FDA approved a supplemental application for desloratadine from Virtus Pharmaceuticals, LLC.

• FDA approval · 2014-04-23
  FDA Approved: CLARINEX — Supplemental Application (Organon LLC)

  The FDA approved a supplemental application for CLARINEX (desloratadine) from Organon LLC.

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• FDA approval · 2014-04-07
  FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Torrent Pharmaceuticals Limited)

  The FDA approved a supplemental application for Montelukast Sodium from Torrent Pharmaceuticals Limited under an ANDA.

• FDA approval · 2014-03-07
  FDA Approved: CLARINEX-D 12 HOUR — Supplemental Application (Organon LLC)

  FDA approved a supplemental NDA for CLARINEX-D 12 HOUR, a desloratadine and pseudoephedrine sulfate combination, to expand its regulatory ap…

• FDA approval · 2014-02-24
  FDA Approved: ZYRTEC ALLERGY — Supplemental Application (Kenvue Brands LLC)

  FDA approved a supplemental application for ZYRTEC ALLERGY (cetirizine hydrochloride) from Kenvue Brands LLC, likely for labeling or indicat…

• FDA approval · 2014-02-21
  FDA Approved: ZYRTEC ALLERGY — Supplemental Application (Kenvue Brands LLC)

  FDA approved a supplemental application for ZYRTEC ALLERGY (cetirizine hydrochloride) submitted by Kenvue Brands LLC.

• FDA approval · 2014-02-12
  FDA Approved: ZYRTEC-D — Supplemental Application (Kenvue Brands LLC)

  The FDA approved a supplemental application for ZYRTEC-D, filed by Kenvue Brands LLC. ZYRTEC-D combines cetirizine hydrochloride and pseudoe…

• FDA approval · 2014-01-30
  FDA Approved: ALLEGRA-D ALLERGY AND CONGESTION — Supplemental Application (Chattem, Inc.)

  FDA approved a supplemental application for ALLEGRA-D ALLERGY AND CONGESTION (fexofenadine hydrochloride and pseudoephedrine hydrochloride) …

• FDA approval · 2014-01-28
  FDA Approved: SINGULAIR — Supplemental Application (Organon LLC)

  FDA approved a supplemental application for Singulair (montelukast sodium) submitted by Organon LLC.

• FDA approval · 2014-01-26
  FDA Approved: ALLERGY RELIEF — Supplemental Application (Ohm Laboratories Inc.)

  FDA approved a supplemental application for Allergy Relief containing loratadine from Ohm Laboratories Inc., indicating a regulatory update …

• FDA approval · 2014-01-21
  FDA Approved: DYMISTA — Supplemental Application (Viatris Specialty LLC)

  The FDA approved a supplemental application for DYMISTA, a combination of azelastine hydrochloride and fluticasone propionate, from Viatris …

• FDA approval · 2014-01-06
  FDA Approved: ALLEGRA-D ALLERGY AND CONGESTION — Supplemental Application (Chattem, Inc.)

  The FDA approved a supplemental application for Allegra-D Allergy and Congestion (fexofenadine hydrochloride and pseudoephedrine hydrochlori…

• FDA approval · 2014-01-03
  FDA Approved: CLARITIN-D 24 HOUR — Supplemental Application (Bayer HealthCare LLC.)

  The FDA approved a supplemental application for Claritin-D 24 Hour, a loratadine/pseudoephedrine sulfate combination from Bayer HealthCare L…

• FDA approval · 2013-12-30
  FDA Approved: SINGULAIR — Supplemental Application (Organon LLC)

  FDA approved a supplemental application for Singulair (montelukast sodium) submitted by Organon LLC.

• FDA approval · 2013-12-09
  FDA Approved: CHILDRENS ALLEGRA ALLERGY — Supplemental Application (Chattem, Inc.)

  FDA approved a supplemental application for CHILDRENS ALLEGRA ALLERGY (fexofenadine hydrochloride) from Chattem, Inc., indicating an approve…

• FDA approval · 2013-12-07
  FDA Approved: NASACORT ALLERGY 24HR — Supplemental Application (Chattem, Inc.)

  FDA approved a supplemental application for Nasacort Allergy 24HR (triamcinolone acetonide) submitted by Chattem, Inc.

• FDA approval · 2013-11-29
  FDA Approved: LEVOCETIRIZINE DIHYDROCHLORIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA granted a supplemental approval for Levocetirizine dihydrochloride by Teva Pharmaceuticals USA, Inc. (generic) under an ANDA supplement.

• FDA approval · 2013-10-18
  FDA Approved: CLARITIN-D 12 HOUR — Supplemental Application (Bayer HealthCare LLC.)

  FDA approved a supplemental application for Claritin-D 12 Hour (loratadine and pseudoephedrine sulfate) from Bayer HealthCare LLC.

• FDA approval · 2013-10-11
  FDA Approved: NASACORT ALLERGY 24HR — Supplemental Application (Chattem, Inc.)

  FDA approves a supplemental application for NASACORT ALLERGY 24HR (triamcinolone acetonide) submitted by Chattem, Inc.

• FDA approval · 2013-09-17
  FDA Approved: LEVOCETIRIZINE DIHYDROCHLORIDE — Original Application (Marlex Pharmaceuticals Inc)

  FDA approved levocetirizine dihydrochloride under an original application for a generic antihistamine indicated for relief of symptoms of al…

• FDA approval · 2013-09-09
  FDA Approved: ALLERGY RELIEF — Supplemental Application (Prodose, Inc)

  FDA approved a supplemental application for ALLERGY RELIEF containing cetirizine hydrochloride, submitted by Prodose, Inc.

• FDA approval · 2013-08-29
  FDA Approved: QNASL — Supplemental Application (Teva Respiratory, LLC)

  FDA approved a supplemental application for QNASL (beclomethasone dipropionate) by Teva Respiratory, LLC.