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FDA Approval Activities for this Drug…
Pseudophedrine Hydrochloride Extended-release tablets, 120 mg, L. Perrigo Company ANDA 75-153 Ibuprofen and Pseudoephedrine Hydrochloride Suspension, Perrigo Co. ACRIVASTINE; PSEUDOEPHEDRINE HYDROCHLORIDE Capsule; 8MG;60MG SEMPREX-D CELLTECH 018506 AZATADINE MALEATE; PSEUDOEPHEDRINE SULFATE Tablet, Extended Release; 1MG;120MG TRINALIN SCHERING 088811 BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE Syrup; 2MG/5ML;10MG/5ML;30MG/5ML MYPHETANE DX Morton Grove 089681 BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE Syrup; 2MG/5ML;10MG/5ML;30MG/5ML BROMFED-DM VERUM 021150 CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE Tablet, Extended Release; 5MG;120MG ZYRTEC-D 12 HOUR PFIZER 088704 CODEINE PHOSPHATE; PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE Syrup; 10MG/5ML;30MG/5ML;1.25MG/5ML TRIACIN-C ALPHARMA 088833 CODEINE PHOSPHATE; PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE Syrup; 10MG/5ML;30MG/5ML;1.25MG/5ML TRIPROLIDINE HCL, PSEUDOEPHEDRINE HCL AND CODEINE PHOSPHATE Morton Grove 020786 FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE Tablet, Extended Release; 60MG;120MG ALLEGRA-D AVENTIS 088193 PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE Tablet; 60MG;2.5MG PSEUDOEPHEDRINE HCL AND TRIPROLIDINE HCL Eon 088602 PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE Tablet; 60MG;2.5MG CORPHED Geneva 088515 PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE Tablet; 60MG;2.5MG TRILITRON NEWTRON 088578 PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE Tablet; 60MG;2.5MG TRIPROLIDINE HCL AND PSEUDOEPHEDRINE HCL SUPERPHARM Loratadine and Pseudoephedrine Sulfate Extended-release Tablets, Andrx Pharmaceuticals, L.L.C. Semprex-D (acrivastine and pseudoephedrine) Capsules, Celltech Pharmaceuticals Fexofenadine HCl & Pseudoephedrine HCl Extended-Release Tablets, Impax Laboratories, Loratadine and Pseudoephedrine Sulfate Extended-release Tablets, Impax Laboratories, Inc. Naproxen Sodium Pseudoephedrine Extended-Release Tablets, L. Perrigo Co. Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride, Mylan Pharmaceuticals, Inc., Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended-release Tablets, Barr Laboratories, Claritin-D 24 Hour (10 mg loratadine and 240 mg pseudoephedrine sulfate) Extended Release Tablets, Schering-Plough, Labeling Revision Claritin-D 12 Hour (loratadine and pseudoephedrine sulfate) Extended Release Tablets, Schering-Plough, New or Modified Indication Claritin-D 24 Hour (loratadine and pseudoephedrine sulfate) Extended Release Tablets, Schering-Plough, New or Modified Indication | Loratadine and Pseudoephedrine Sulfate ER Tablets, Ranbaxy, Approval | Allegra-D (fexofenadine HCl 60 mg/pseudoephedrine HCl 120mg) Extended-Release Tablets, Aventis, Labeling Revision | Mucinex D (guaifenesin & pseudoephedrine HCl) Extended-release Bi-layer Tablets, Adams Respiratory, Package Change | Pseudoephedrine Hydrochloride Extended-release, Tablets, Ranbaxy Inc., Approval | Mucinex DM Extended-release Bi-layer Tablets, Adams Respiratory Ther., Package Change | Naproxen Sodium and Pseudoephedrine Hydrochloride Extended-Release Tablets, Dr. Reddy’s Labs, Approval | Mucinex D (guaifenesin, pseudoephedrine HCl and 1200 mg guaifenesin/120 mg pseudoephedrine HCl) Extended Release Bi-layer Tablets, Adams Respiratory Therapeutics, Formulation Revision | Zyrtec-D (cetirizine HCl/pseudoephedrine HCl) Tablets, Pfizer Inc., OTC Labeling Revision | Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets, Teva Pharma, Approval | Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets, Sandoz Inc., Approval | Advil Cold & Sinus (ibuprofen and pseudoephedrine HCl) Tablets, Wyeth Consumer Healthcare, Labeling Revision | Advil Cold & Sinus (ibuprofen and pseudoephedrine hydrochloride) Capsules, Wyeth Consumer Healthcare, Labeling Revision | Advil Allergy Sinus (chlorpheniramine maleate, ibuprofen, and pseudoephedrine hydrochloride) Tablets, Wyeth Consumer Healthcare, Labeling Revision | Aleve Cold and Sinus (naproxen sodium and pseudoephedrine hydrochloride) Extended-Release Tablets, Bayer Healthcare, LLC, Labeling Revision | Children’s Advil Cold (ibuprofen and pseudoephedrine hydrochloride), Wyeth Consumer Healthcare, Labeling Revision
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