Mar 012016
 

March 1, 2016

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Clindesse clindamycin phosphate Cream;Vaginal Elan Pharma Intl Ltd Manufacturing Change or Addition
Faslodex fulvestrant Injectable;Intramuscular Astrazeneca Labeling Revision
Invega paliperidone Tablet, Extended Release;Oral Janssen Pharms Labeling Revision
Invega Sustenna paliperidone palmitate Suspension, Extended Release;Intramuscular Janssen Pharms Labeling Revision
Invega Trinza paliperidone palmitate Suspension, Extended Release;Intramuscular Janssen Pharms Labeling Revision
Maxipime cefepime hydrochloride Injectable;Injection Hospira Inc Labeling Revision
Palonosetron Hydrochloride palonosetron hydrochloride Injectable; Injection Dr Reddys Labs Ltd Approval
Risperdal risperidone Tablet;Oral Janssen Pharms Labeling Revision
Risperdal risperidone Solution;Oral Janssen Pharms Labeling Revision
Risperdal risperidone Tablet, Orally Disintegrating;Oral Janssen Pharms Labeling Revision
Risperdal Consta risperidone Injectable;Intramuscular Janssen Pharms Labeling Revision
Zocor simvastatin Tablet;Oral Merck Manufacturing Change or Addition
Zortress everolimus Tablet;Oral Novartis Manufacturing Change or Addition