USFDA: New and Generic Drug Approvals: 07 OCT 2014

New and Generic Drug Approvals

October 7, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Ambien zolpidem tartrate Tablet;Oral Sanofi Aventis Us Labeling Revision
Ambien Cr zolpidem tartrate Tablet, Extended Release;Oral Sanofi Aventis Us Labeling Revision
Benicar olmesartan medoxomil Tablet;Oral Daiichi Sankyo Manufacturing Change or Addition
Budesonide budesonide Solution;Topical Foam Salix Pharms Approval
Darunavir Ethanolate darunavir ethanolate Tablet;Oral Hetero Labs Unit Iii Tentative Approval
Lo Minastrin Fe ethinyl estradiol; norethindrone acetate Tablet, Chewable, Tablet;Oral Warner Chilcott Manufacturing Change or Addition
Otrexup methotrexate Solution;Subcutaneous Antares Pharma Inc Manufacturing Change or Addition
Torisel temsirolimus Solution;Intravenous Pf Prism Cv Labeling Revision
Zoladex goserelin acetate Implant;Implantation Astrazeneca Labeling Revision
Zoladex goserelin acetate Implant;Implantation Astrazeneca Labeling Revision

No comments:

Post a Comment