Allergic Rhinitis

• FDA approval · 2012-08-03
  FDA Approved: MONTELUKAST SODIUM — Original Application (Lannett Company, Inc.)

  FDA approves the original application for Montelukast Sodium (generic montelukast) manufactured by Lannett Company, Inc. The approval enable…

• FDA approval · 2012-08-03
  FDA Approved: MONTELUKAST SODIUM — Original Application (Torrent Pharmaceuticals Limited)

  FDA approved Torrent Pharmaceuticals Limited's original ANDA for montelukast sodium, establishing a generic version of montelukast for the a…

• FDA approval · 2012-07-16
  FDA Approved: SINGULAIR — Supplemental Application (Organon LLC)

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

• FDA approval · 2012-06-29
  FDA Approved: LEVOCETIRIZINE DIHYDROCHLORIDE — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approved Camber Pharmaceuticals' original application for levocetirizine dihydrochloride, a generic antihistamine. It is indicated for a…

• FDA approval · 2012-06-28
  FDA Approved: PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE — Original Application (Cranbury Pharmaceuticals, LLC)

  FDA approved Cranbury Pharmaceuticals' generic Promethazine hydrochloride and dextromethorphan hydrobromide product under an Original Applic…

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• FDA approval · 2012-06-28
  FDA Approved: PROMETHAZINE HYDROCHLORIDE — Original Application (Cranbury Pharmaceuticals, LLC)

  The FDA approved Promethazine hydrochloride as an original generic drug application (ANDA) for Cranbury Pharmaceuticals, LLC.

• FDA approval · 2012-05-31
  FDA Approved: AZELASTINE HYDROCHLORIDE — Original Application (Sandoz Inc)

  FDA approved the original application for azelastine hydrochloride, a generic product from Sandoz Inc.

• FDA approval · 2012-05-22
  FDA Approved: CHILDRENS ZYRTEC — Supplemental Application (Kenvue Brands LLC)

  FDA approved a supplemental application for Children's Zyrtec (cetirizine hydrochloride) by Kenvue Brands LLC.

• FDA approval · 2012-05-11
  FDA Approved: CETIRIZINE HYDROCHLORIDE — Original Application (Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.)

  The FDA approved the original ANDA for cetirizine hydrochloride (oral solution) from Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals La…

• FDA approval · 2012-05-01
  FDA Approved: DYMISTA — Original Application (Viatris Specialty LLC)

  FDA approved DYMISTA (azelastine hydrochloride and fluticasone propionate) under an Original Application by Viatris Specialty LLC, introduci…

• FDA approval · 2012-04-19
  FDA Approved: DESLORATADINE — Original Application (Virtus Pharmaceuticals, LLC)

  The FDA approved Virtus Pharmaceuticals, LLC’s generic desloratadine via an Original Application (ANDA). This adds a generic option for desl…

• FDA approval · 2012-02-23
  FDA Approved: ALLEGRA HIVES 24HR — Supplemental Application (Chattem, Inc.)

  FDA approved a supplemental application for Allegra Hives 24HR (fexofenadine hydrochloride) submitted by Chattem, Inc., approving the change…

• FDA approval · 2012-02-10
  FDA Approved: DESLORATADINE — Original Application (Natco Pharma USA LLC)

  FDA approved an original application for a desloratadine generic from Natco Pharma USA LLC.

• FDA approval · 2012-02-06
  FDA Approved: FEXOFENADINE HYDROCHLORIDE — Original Application (AMERISOURCE BERGEN)

  FDA approved an original application for fexofenadine hydrochloride (a generic antihistamine) with Amerisource Bergen. The product is indica…

• FDA approval · 2012-02-03
  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 · 2012-02-03
  FDA Approved: ALLEGRA-D ALLERGY AND CONGESTION — Supplemental Application (Chattem, Inc.)

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

• FDA approval · 2012-01-09
  FDA Approved: FLUTICASONE PROPIONATE SPRAY, METERED — Original Application (Chartwell RX, LLC)

  The FDA approved the original application for Fluticasone Propionate Spray, Metered, a generic nasal spray (fluticasone propionate) submitte…

• FDA approval · 2011-12-21
  FDA Approved: ADVIL ALLERGY AND CONGESTION RELIEF — Original Application (Haleon US Holdings LLC)

  FDA approved the original application for Advil Allergy and Congestion Relief, a combination product containing chlorpheniramine maleate, ib…

• FDA approval · 2011-12-16
  FDA Approved: SINGULAIR — Supplemental Application (Organon LLC)

  FDA approved a supplemental application for Singulair (montelukast) by Organon LLC, resulting in an update to the product labeling via a sup…

• FDA approval · 2011-11-18
  FDA Approved: DESLORATADINE — Supplemental Application (Dr. Reddy's Laboratories Limited)

  The FDA approved a supplemental application for desloratadine submitted by Dr. Reddy's Laboratories Limited, marking an approval of changes …

• FDA approval · 2011-11-07
  FDA Approved: LEVOCETIRIZINE DIHYDROCHLORIDE — Original Application (Padagis Israel Pharmaceuticals Ltd)

  FDA approves the original application for levocetirizine dihydrochloride from Padagis Israel Pharmaceuticals Ltd, a generic antihistamine.

• FDA approval · 2011-10-01
  FDA Approved: CHILDRENS CETIRIZINE HYDROCHLORIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for Sun Pharmaceutical Industries' Children's Cetirizine Hydrochloride. The action updates the label…

• FDA approval · 2011-09-01
  FDA Approved: FLONASE SENSIMIST ALLERGY RELIEF — Supplemental Application (Haleon US Holdings LLC)

  The FDA approved a supplemental application for Flonase Sensimist Allergy Relief (fluticasone furoate) by Haleon US Holdings LLC. The action…

• FDA approval · 2011-08-30
  FDA Approved: CETIRIZINE HYDROCHLORIDE — Original Application (OHM LABORATORIES INC.)

  FDA approved the original application for cetirizine hydrochloride by OHM Laboratories, a generic antihistamine. It is used to treat allergi…

• FDA approval · 2011-08-22
  FDA Approved: LEVOCETIRIZINE DIHYDROCHLORIDE — Original Application (Teva Pharmaceuticals USA, Inc.)

  FDA approves Teva's original generic application for levocetirizine dihydrochloride, enabling market entry for this antihistamine.