Allergic Rhinitis

• FDA approval · 2016-03-08
  FDA Approved: BUDESONIDE — Original Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a generic budesonide product under an Original Application (ANDA 204548) for Teva Pharmaceuticals USA, Inc. This marks the appr…

• FDA approval · 2016-03-01
  FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Torrent Pharmaceuticals Limited)

  FDA approved Torrent Pharmaceuticals Limited's supplemental application for Montelukast Sodium (montelukast) under an ANDA.

• FDA approval · 2016-02-29
  FDA Approved: QNASL — Supplemental Application (Teva Respiratory, LLC)

  FDA approved a supplemental application for QNASL (beclomethasone dipropionate) from Teva Respiratory, LLC. The approval updates the product…

• FDA approval · 2016-02-29
  FDA Approved: FLUTICASONE PROPIONATE — Original Application (Selder, S.A. de C.V.)

  FDA approved the Original Application for a generic nasal spray containing fluticasone propionate (Allergy Relief Nasal) from Selder, S.A. d…

• FDA approval · 2016-02-12
  FDA Approved: CLARITIN ALLERGY — Supplemental Application (Bayer HealthCare LLC.)

  FDA approved a supplemental application for Claritin Allergy (loratadine) submitted by Bayer HealthCare LLC.

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• FDA approval · 2016-01-26
  FDA Approved: ALLERGY RELIEF — Supplemental Application (Prodose, Inc)

  The FDA approved a supplemental application for Allergy Relief containing cetirizine hydrochloride from Prodose, Inc, under ANDA077829.

• FDA approval · 2016-01-26
  FDA Approved: FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI — Supplemental Application (Dr.Reddy's Laboratories Limited)

  FDA approved a supplemental application for Fexofenadine HCl and Pseudoephedrine HCl (Dr. Reddy's Laboratories Limited). This approval invol…

• FDA approval · 2016-01-11
  FDA Approved: LEVOCETIRIZINE DIHYDROCHLORIDE — Original Application (Macleods Pharmaceuticals Limited)

  FDA approved the original application for levocetirizine dihydrochloride from Macleods Pharmaceuticals Limited as a generic antihistamine.

• FDA approval · 2016-01-04
  FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Torrent Pharmaceuticals Limited)

  The FDA approves a supplemental application for Montelukast Sodium from Torrent Pharmaceuticals Limited under ANDA 201515.

• FDA approval · 2015-12-30
  FDA Approved: CLARITIN ALLERGY — Supplemental Application (Bayer HealthCare LLC.)

  The FDA approved a supplemental application for CLARITIN ALLERGY (loratadine) from Bayer HealthCare LLC.

• FDA approval · 2015-12-23
  FDA Approved: CLARITIN CHEWABLE GRAPE AND BUBBLEGUM — Supplemental Application (Bayer HealthCare LLC.)

  The FDA approved a supplemental application to add Claritin chewable grape and bubblegum formulations containing loratadine from Bayer Healt…

• FDA approval · 2015-12-10
  FDA Approved: CLARITIN ALLERGY — Supplemental Application (Bayer HealthCare LLC.)

  FDA approved a supplemental application for Claritin Allergy (loratadine) by Bayer HealthCare LLC., under NDA020641. This action represents …

• FDA approval · 2015-12-09
  FDA Approved: CLARITIN LIQUI-GELS — Supplemental Application (Bayer HealthCare LLC.)

  This FDA entry records a supplemental application for Claritin Liqui-Gels (loratadine) submitted by Bayer HealthCare LLC. The submission sta…

• FDA approval · 2015-12-08
  FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental application for Montelukast sodium from Rising Pharma Holdings, Inc. under an ANDA, marking approval of a supple…

• FDA approval · 2015-12-02
  FDA Approved: CARBINOXAMINE MALEATE EXTENDED-RELEASE ORAL SUSPENSION — Supplemental Application (Neos Therapeutics, LP)

  FDA approved a supplemental application for an extended-release oral suspension form of carbinoxamine maleate, adding a new dosage form to t…

• FDA approval · 2015-11-30
  FDA Approved: BUDESONIDE — Supplemental Application (Chartwell RX, LLC)

  The FDA approved a supplemental application for Budesonide from Chartwell RX, LLC, authorizing a change to an existing generic product.

• FDA approval · 2015-11-25
  FDA Approved: CLARITIN-D 12 HOUR — Supplemental Application (Bayer HealthCare LLC.)

  FDA approved a supplemental application for Claritin-D 12 Hour, combining loratadine and pseudoephedrine sulfate. The approval expands the p…

• FDA approval · 2015-11-25
  FDA Approved: CLARITIN-D 24 HOUR — Supplemental Application (Bayer HealthCare LLC.)

  The FDA approved a supplemental application for Claritin-D 24 Hour (loratadine and pseudoephedrine sulfate) from Bayer HealthCare LLC.

• FDA approval · 2015-11-25
  FDA Approved: CHILDRENS FLONASE ALLERGY RELIEF — Supplemental Application (Haleon US Holdings LLC)

  FDA approved a supplemental application for Children's Flonase Allergy Relief (fluticasone propionate) from Haleon US Holdings LLC, expandin…

• FDA approval · 2015-11-25
  FDA Approved: CLARITIN REDITABS — Supplemental Application (Bayer Healthcare LLC.)

  FDA approved a supplemental application for Claritin RediTabs (loratadine) from Bayer Healthcare, likely related to a labeling or formulatio…

• FDA approval · 2015-11-25
  FDA Approved: CLARITIN REDITABS — Supplemental Application (Bayer HealthCare LLC)

  The FDA approved a supplemental application for Claritin RediTabs (loratadine) from Bayer HealthCare LLC.

• FDA approval · 2015-11-25
  FDA Approved: LEVOCETIRIZINE DIHYDROCHLORIDE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  The FDA approved a supplemental application for Glenmark Pharmaceuticals' generic levocetirizine dihydrochloride.

• FDA approval · 2015-11-24
  FDA Approved: LEVOCETIRIZINE DIHYDROCHLORIDE — Supplemental Application (Camber Pharmaceuticals, Inc.)

  FDA approved a supplemental application for levocetirizine dihydrochloride from Camber Pharmaceuticals, confirming its status as a generic a…

• FDA approval · 2015-11-20
  FDA Approved: BUDESONIDE — Supplemental Application (Rite Aid Corporation)

  FDA approved a supplemental application for Budesonide filed by Rite Aid Corporation (ANDA078949), confirming an updated approval for this g…

• FDA approval · 2015-10-21
  FDA Approved: CLARITIN ALLERGY — Supplemental Application (Bayer HealthCare LLC.)

  FDA approved a supplemental application for Claritin Allergy (loratadine) submitted by Bayer HealthCare LLC.