May 9, 2014
Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Atrovent Hfa29 ipratropium bromide Aerosol, Metered;Inhalation Boehringer Ingelheim Manufacturing Change or Addition
Cleocin30 clindamycin phosphate Cream;Vaginal Pharmacia and Upjohn Labeling Revision
Cleocin31 clindamycin phosphate Suppository;Vaginal Pharmacia and Upjohn Labeling Revision
Differin32 adapalene Gel;Topical Galderma Labs Lp Manufacturing Change or Addition
Fludeoxyglucose F1833 fludeoxyglucose f-18 Injectable;Intravenous Ucsf Rodiopharm Approval
Irbesartan and Hydrochlorothiazide34 hydrochlorothiazide; irbesartan Tablet;Oral Prinston Inc Approval
Lidocaine Hydrochloride 0.2% In Dextrose 5% In Plastic Container35 lidocaine hydrochloride Injectable;Injection Hospira Manufacturing Change or Addition
Lidocaine Hydrochloride 0.4% In Dextrose 5% In Plastic Container36 lidocaine hydrochloride Injectable;Injection Hospira Manufacturing Change or Addition
Lidocaine Hydrochloride 0.8% In Dextrose 5% In Plastic Container37 lidocaine hydrochloride Injectable;Injection Hospira Manufacturing Change or Addition
Oxytocin38 oxytocin Injectable;Injection Baxter Hlthcare Corp Manufacturing Change or Addition