Allergic Rhinitis

• FDA approval · 2021-01-25
  FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Accord Healthcare Inc.)

  FDA approved a supplemental application for Accord Healthcare Inc.'s montelukast sodium product under ANDA 202717.

• FDA approval · 2021-01-11
  FDA Approved: CLARITIN REDITABS — Supplemental Application (Bayer Healthcare LLC.)

  FDA approved a supplemental application for CLARITIN REDITABS (loratadine) from Bayer Healthcare LLC., enabling a new or revised indication …

• FDA approval · 2021-01-07
  FDA Approved: CLARITIN CHEWABLE GRAPE AND BUBBLEGUM — Supplemental Application (Bayer HealthCare LLC.)

  The FDA approved a supplemental application for Claritin Chewable Grape and Bubblegum (loratadine) by Bayer HealthCare LLC, adding a chewabl…

• FDA approval · 2020-12-07
  FDA Approved: CETIRIZINE HCL — Supplemental Application (AMERISOURCE BERGEN)

  The FDA approved a supplemental application for cetirizine hydrochloride submitted by AmerisourceBergen.

• FDA approval · 2020-11-25
  FDA Approved: AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE — Supplemental Application (Apotex Corp.)

  FDA approved a supplemental application for azelastine hydrochloride and fluticasone propionate by Apotex Corp.

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• FDA approval · 2020-11-12
  FDA Approved: NASAL ALLERGY — Supplemental Application (Kroger Company)

  FDA approved Kroger's NASAL ALLERGY nasal spray containing triamcinolone acetonide via a supplemental application. This action updates the p…

• FDA approval · 2020-11-10
  FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Dr.Reddy's Laboratories Limited)

  The FDA approved a supplemental application for montelukast sodium from Dr. Reddy's Laboratories Limited, under an ANDA.

• FDA approval · 2020-11-10
  FDA Approved: CHILDRENS XYZAL ALLERGY — Supplemental Application (Chattem, Inc.)

  The FDA approved a supplemental application for CHILDRENS XYZAL ALLERGY (levocetirizine dihydrochloride) from Chattem, Inc., expanding the l…

• FDA approval · 2020-11-10
  FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Dr.Reddy's Laboratories Limited)

  FDA approved a supplemental application for Montelukast Sodium from Dr. Reddy's Laboratories Limited, granting continued approval of a gener…

• FDA approval · 2020-11-02
  FDA Approved: CHILDRENS ALLEGRA ALLERGY — Supplemental Application (Chattem, Inc.)

  The FDA approved a supplemental application for Children's Allegra Allergy (fexofenadine hydrochloride) submitted by Chattem, Inc.

• FDA approval · 2020-10-30
  FDA Approved: LORATADINE — Original Application (Tenshi Kaizen Pvt Ltd)

  FDA approved an original generic application for loratadine (Tenshi Kaizen Pvt Ltd).

• FDA approval · 2020-10-20
  FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Ajanta Pharma USA Inc.)

  FDA approved Ajanta Pharma USA Inc.'s supplemental application for Montelukast Sodium, marking approval of a generic montelukast product und…

• FDA approval · 2020-10-20
  FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Ajanta Pharma USA Inc.)

  FDA approved Ajanta Pharma USA Inc.'s supplemental application for Montelukast Sodium, authorizing a generic Montelukast product.

• FDA approval · 2020-10-20
  FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Ajanta Pharma USA Inc.)

  FDA approved a supplemental application for Montelukast Sodium (ANDA 203432) from Ajanta Pharma USA Inc., granting approval of this generic …

• FDA approval · 2020-10-05
  FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Torrent Pharmaceuticals Limited)

  FDA approved a supplemental application for Montelukast Sodium by Torrent Pharmaceuticals Limited (ANDA 201515).

• FDA approval · 2020-09-21
  FDA Approved: ALL DAY ALLERGY — Original Application (WALMART INC. (see also Equate))

  FDA approved Walmart's All Day Allergy cetirizine hydrochloride as an original generic application (ANDA 213105), enabling a Walmart/Equate …

• FDA approval · 2020-09-18
  FDA Approved: LORATADINE — Original Application (Tenshi Kaizen Pvt Ltd)

  FDA approved Tenshi Kaizen Pvt Ltd's Loratadine as an original generic application. The product is indicated for allergic rhinitis and urtic…

• FDA approval · 2020-09-11
  FDA Approved: CETIRIZINE HYDROCHLORIDE — Original Application (Aurohealth LLC)

  FDA approved the original generic application for cetirizine hydrochloride to be marketed by Aurohealth LLC.

• FDA approval · 2020-09-10
  FDA Approved: LORATADINE — Original Application (Advagen Pharma Limited)

  FDA approved Advagen Pharma Limited's original ANDA for loratadine, a generic antihistamine indicated for allergic rhinitis and chronic idio…

• FDA approval · 2020-09-04
  FDA Approved: MONTELUKAST — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application from Sandoz Inc for montelukast under the ANDA, confirming changes to the generic product's labeling…

• FDA approval · 2020-09-04
  FDA Approved: MONTELUKAST SODIUM — Original Application (Amneal Pharmaceuticals LLC)

  FDA approved Amneal Pharmaceuticals' Montelukast Sodium as a generic version of montelukast for the prevention and maintenance treatment of …

• FDA approval · 2020-08-07
  FDA Approved: CLARITIN CHEWABLE GRAPE AND BUBBLEGUM — Supplemental Application (Bayer HealthCare LLC.)

  FDA approved a supplemental application to add Claritin Chewable Grape and Bubblegum (loratadine) as a new chewable dosage form. This expand…

• FDA approval · 2020-07-15
  FDA Approved: BUDESONIDE — Supplemental Application (Padagis US LLC)

  FDA approved a supplemental application for budesonide submitted by Padagis US LLC. The approval updates the labeling for budesonide under t…

• FDA approval · 2020-07-14
  FDA Approved: BROMPHENIRAMINE, PSEUDOEPHEDRINE, DEXTROMETHORPHAN — Original Application (Ascend Laboratories, LLC)

  FDA approves the original ANDA for a triple-ingredient cough/cold product containing brompheniramine, pseudoephedrine, and dextromethorphan …

• FDA approval · 2020-06-16
  FDA Approved: BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, — Original Application (Eywa Pharma Inc)

  FDA approved Eywa Pharma Inc for the original application of a generic brompheniramine maleate and pseudoephedrine hydrochloride combination…