Common Cold

• FDA approval · 2009-12-30
  FDA Approved: CLARINEX-D 12 HOUR — Supplemental Application (Organon LLC)

  FDA approved a supplemental application for CLARINEX-D 12 HOUR, a combination of desloratadine and pseudoephedrine sulfate, manufactured by …

• FDA approval · 2009-08-25
  FDA Approved: PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE — Original Application (Amneal Pharmaceuticals LLC)

  FDA approved Amneal Pharmaceuticals' original application for a generic Promethazine hydrochloride and phenylephrine hydrochloride product.

• FDA approval · 2009-05-19
  FDA Approved: ADVIL COLD AND SINUS — Supplemental Application (Haleon US Holdings LLC)

  FDA approved a supplemental application for Advil Cold and Sinus (ibuprofen and pseudoephedrine hydrochloride) from Haleon US Holdings LLC.

• FDA approval · 2009-05-19
  FDA Approved: ADVIL ALLERGY SINUS — Supplemental Application (Haleon US Holdings LLC)

  The FDA approved a supplemental application for Advil Allergy Sinus, a multi-ingredient combination product from Haleon US Holdings LLC.

• FDA approval · 2009-05-19
  FDA Approved: ADVIL COLD AND SINUS — Supplemental Application (Haleon US Holdings LLC)

  The FDA approved a supplemental application for Advil Cold and Sinus, incorporating ibuprofen with pseudoephedrine hydrochloride to expand l…

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• FDA approval · 2009-04-03
  FDA Approved: MUCINEX DM MAXIMUM STRENGTH — Supplemental Application (RB Health (US) LLC)

  FDA approved a supplemental application for Mucinex DM Maximum Strength (guaifenesin and dextromethorphan hydrobromide) submitted by RB Heal…

• FDA approval · 2008-09-23
  FDA Approved: SINUS AND COLD D — Supplemental Application (Meijer Distribution Inc)

  FDA approved a supplemental application for Sinus and Cold D, a naproxen sodium and pseudoephedrine hydrochloride combination, distributed b…

• FDA approval · 2008-08-22
  FDA Approved: GOOD SENSE CHILDRENS IBUPROFEN — Supplemental Application (L. Perrigo Company)

  FDA approved a supplemental application for Good Sense Children’s Ibuprofen (ibuprofen) from L. Perrigo Company.

• FDA approval · 2007-11-09
  FDA Approved: ZYRTEC-D — Supplemental Application (Kenvue Brands LLC)

  The FDA approved a supplemental application for ZYRTEC-D (cetirizine hydrochloride and pseudoephedrine hydrochloride) by Kenvue Brands LLC.

• FDA approval · 2007-09-06
  FDA Approved: GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE — Supplemental Application (WALGREEN COMPANY)

  FDA approved Walgreens' supplemental application for Guaifenesin and Pseudoephedrine Hydrochloride.

• FDA approval · 2006-12-19
  FDA Approved: SINUS AND COLD D — Supplemental Application (Meijer Distribution Inc)

  FDA approves a supplemental ANDA for Sinus and Cold D, a combination product containing naproxen sodium and pseudoephedrine hydrochloride di…

• FDA approval · 2006-12-07
  FDA Approved: PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE — Original Application (Genus Lifesciences Inc.)

  FDA approved Genus Lifesciences' original application for a generic promethazine hydrochloride and phenylephrine hydrochloride product, a co…

• FDA approval · 2006-09-27
  FDA Approved: IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE — Supplemental Application (Rite-Aid)

  FDA approved a supplemental application for Rite Aid's ibuprofen and pseudoephedrine hydrochloride product, indicating an approval modificat…

• FDA approval · 2006-08-23
  FDA Approved: MUCINEX — Supplemental Application (RB Health (US) LLC)

  FDA approved a supplemental application for Mucinex (guaifenesin) from RB Health (US) LLC, indicating FDA action on a supplemental submissio…

• FDA approval · 2006-06-07
  FDA Approved: CARBZAH — Supplemental Application (IPG Pharmaceuticals, inc.)

  The FDA approved a supplemental application for CARBZAH (carbinoxamine maleate) from IPG Pharmaceuticals, Inc., indicating regulatory approv…