Allergic Rhinitis

• FDA approval · 2015-02-03
  FDA Approved: QNASL — Supplemental Application (Teva Respiratory, LLC)

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

• FDA approval · 2015-01-29
  FDA Approved: FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE — Original Application (AmeriSource Bergen)

  FDA approved the original ANDA for a combination product of fexofenadine hydrochloride and pseudoephedrine hydrochloride to relieve allergy …

• FDA approval · 2015-01-24
  FDA Approved: HYDROXYZINE PAMOATE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved Teva’s supplemental application for hydroxyzine pamoate, confirming its status as an approved generic drug. The action rela…

• FDA approval · 2014-12-30
  FDA Approved: CETIRIZINE HYDROCHLORIDE — Supplemental Application (Rising Pharma Holdings, Inc.)

  The FDA approved a supplemental application for cetirizine hydrochloride by Rising Pharma Holdings, Inc., expanding regulatory approval for …

• FDA approval · 2014-12-02
  FDA Approved: ALLEGRA HIVES 24HR — Supplemental Application (Chattem, Inc.)

  The FDA approved a supplemental application for Allegra Hives 24HR (fexofenadine hydrochloride) from Chattem, Inc., indicating a regulatory …

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• FDA approval · 2014-11-26
  FDA Approved: SINGULAIR — Supplemental Application (Organon LLC)

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

• FDA approval · 2014-11-18
  FDA Approved: FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI — Original Application (Dr. Reddy's Laboratories Inc.)

  FDA approved the original application for a fixed-dose combination of fexofenadine HCl and pseudoephedrine HCl from Dr. Reddy's Laboratories…

• FDA approval · 2014-11-14
  FDA Approved: NASAL ALLERGY — Supplemental Application (Kroger Company)

  The FDA approved a supplemental application for the Kroger Company's NASAL ALLERGY product containing Triamcinolone Acetonide (ANDA078104).

• FDA approval · 2014-11-07
  FDA Approved: HIVES RELIEF — Supplemental Application (WALGREEN COMPANY)

  FDA approved a supplemental application for HIVES RELIEF, a cetirizine hydrochloride tablet product from Walgreens Company. The approval cov…

• FDA approval · 2014-11-07
  FDA Approved: LORATADINE — Supplemental Application (Lannett Company, Inc.)

  The FDA approved a supplemental application for loratadine from Lannett Company, expanding the availability of this generic antihistamine.

• FDA approval · 2014-11-05
  FDA Approved: HIVES RELIEF — Supplemental Application (WALGREEN COMPANY)

  FDA approved a supplemental application for HIVES RELIEF, a cetirizine tablet product from Walgreens. Cetirizine is used to treat allergic s…

• FDA approval · 2014-10-29
  FDA Approved: DYMISTA — Supplemental Application (Viatris Specialty LLC)

  FDA approved a supplemental application for DYMISTA (azelastine hydrochloride and fluticasone propionate) from Viatris Specialty LLC, under …

• FDA approval · 2014-10-21
  FDA Approved: ALLERGY AND CONGESTION RELIEF — Supplemental Application (L. Perrigo Company)

  The FDA approved a supplemental application for an allergy and congestion relief product containing loratadine and pseudoephedrine sulfate b…

• FDA approval · 2014-09-12
  FDA Approved: ALLEGRA HIVES 24HR — Supplemental Application (Chattem, Inc.)

  The FDA approved a supplemental application for Allegra Hives 24HR (fexofenadine hydrochloride) submitted by Chattem, Inc., likely updating …

• FDA approval · 2014-09-10
  FDA Approved: MONTELUKAST — Original Application (XLCare Pharmaceuticals Inc.)

  FDA approves the original abbreviated new drug application for Montelukast (generic) submitted by XLCare Pharmaceuticals Inc.

• FDA approval · 2014-09-09
  FDA Approved: LEVOCETIRIZINE DIHYDROCHLORIDE — Original Application (Vensun Pharmaceuticals, Inc.)

  FDA approved the original application (ANDA) for levocetirizine dihydrochloride by Vensun Pharmaceuticals, Inc., providing a generic version…

• FDA approval · 2014-08-19
  FDA Approved: GOOD NEIGHBOR PHARMACY CHILDRENS LORATADINE — Supplemental Application (AmerisourceBergen)

  FDA approved a supplemental application for Good Neighbor Pharmacy Children's Loratadine (loratadine) from AmerisourceBergen. The approval i…

• FDA approval · 2014-07-25
  FDA Approved: CLARITIN CHEWABLE GRAPE AND BUBBLEGUM — Supplemental Application (Bayer HealthCare LLC.)

  FDA approved a supplemental application for Claritin Chewable Grape and Bubblegum containing loratadine, expanding the product line with a n…

• FDA approval · 2014-07-23
  FDA Approved: CHILDRENS FLONASE ALLERGY RELIEF — Original Application (Haleon US Holdings LLC)

  FDA approved the original application for Children's Flonase Allergy Relief (fluticasone propionate) by Haleon US Holdings LLC.

• FDA approval · 2014-07-22
  FDA Approved: CLARITIN REDITABS — Supplemental Application (Bayer HealthCare LLC)

  FDA approved a supplemental NDA for Claritin RediTabs (loratadine) by Bayer HealthCare LLC.

• FDA approval · 2014-07-22
  FDA Approved: CLARITIN REDITABS — Supplemental Application (Bayer Healthcare LLC.)

  FDA approved a supplemental application for Claritin RediTabs (loratadine) from Bayer Healthcare LLC, updating the approved formulation. Lor…

• FDA approval · 2014-07-10
  FDA Approved: QNASL — Supplemental Application (Teva Respiratory, LLC)

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

• 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 · 2014-06-12
  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 · 2014-06-03
  FDA Approved: HYDROXYZINE HYDROCHLORIDE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for hydroxyzine hydrochloride (HYDROXYZINE HYDROCHLORIDE) from Chartwell RX, LLC.