New and Generic Drug Approvals (Apr 22):

*Ciprofloxacin in Dextrose 5% in Plastic Container Injection, Hikma Farmaceutica, Approval *ENABLEX (darifenacin hydrobromide) Extended Release Tablets, Novartis Pharma, Labeling Revision *Hydrocodone Bitartrate and Acetaminophen Oral Solution, Pharmaceutical Assoc., Approval *SINGULAIR (montelukast sodium) Tablets, Merck & Co., Labeling Revision *SINGULAIR (montelukast sodium) Chewable Tablets, Merck & Co., Labeling Revision *SINGULAIR (montelukast sodium) Oral Granules, Merck & Co., Labeling Revision *TIGAN (trimethobenzamide hydrochloride) Intramuscular Injection, JHP Pharma, Labeling Revision 

New and Generic Drug Approvals (Apr 21):

*AUGMENTIN ES-600 (amoxicillin, clavulanate potassium) Powder for Oral Suspension, GlaxoSmithKline, Labeling Revision *AUGMENTIN XR (amoxicillin, clavulanate potassium) Extended Release Tablets, GlaxoSmithKline, Labeling Revision *COPEGUS (ribavirin) Tablets, Roche, Labeling Revision *CRIXIVAN (indinavir sulfate) Capsules, Merck & Co., Labeling Revision *Cyclobenzaprine Hydrochloride Tablets, Amneal Pharma, Approval *Felodipine Extended-release Tablets, Mylan Pharma, Approval *Metformin Hydrochloride Extended-Release Tablets, NeuroSci Inc., Approval *Oxacillin (oxacillin sodium) Injection, Baxter Healthcare, Labeling Revision *SYNTHROID (levothyroxine sodium) Tablets, Abbott Labs, Labeling Revision *TIMENTIN in Plastic Container (ticarcillin disodium, clavulanate potassium) Injection, GlaxoSmithKline, Labeling Revision *TIMENTIN (ticarcillin disodium, clavulanate potassium) Injection, GlaxoSmithKline, Labeling Revision *ZOSYN (piperacillin sodium, tazobactam sodium) Injection, Wyeth Pharma, Labeling Revision *ZOSYN in Plastic Container (piperacillin sodium, tazobactam sodium) Injection, Wyeth Pharma, Labeling Revision