Feb 182016
 

February 18, 2016

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Dantrolene Sodium dantrolene sodium Injectable;Injection Mylan Institutional Approval
Depacon valproate sodium Injectable;Injection Abbvie Labeling Revision
Depakene valproic acid Capsule;Oral Abbvie Labeling Revision
Depakene valproic acid Syrup;Oral Abbvie Labeling Revision
Depakote divalproex sodium Capsule, Delayed Rel Pellets;Oral Abbvie Labeling Revision
Doxycycline doxycycline Capsule;Oral Zydus Pharms Usa Inc Approval
Gabapentin gabapentin Capsule;Oral Sciegen Pharms Inc Approval
Odomzo sonidegib phosphate Capsule;Oral Novartis Pharms Corp Labeling Revision
Rizatriptan Benzoate rizatriptan benzoate Tablet;Oral Alkem Labs Ltd Approval
Sodium Polystyrene Sulfonate sodium polystyrene sulfonate Powder;Oral, Rectal Invatech Pharma Approval
Stalevo 100 carbidopa; entacapone; levodopa Tablet;Oral Orion Pharma Manufacturing Change or Addition
Stalevo 125 carbidopa; entacapone; levodopa Tablet;Oral Orion Pharma Manufacturing Change or Addition
Stalevo 150 carbidopa; entacapone; levodopa Tablet;Oral Orion Pharma Manufacturing Change or Addition
Stalevo 200 carbidopa; entacapone; levodopa Tablet;Oral Orion Pharma Manufacturing Change or Addition
Stalevo 50 carbidopa; entacapone; levodopa Tablet;Oral Orion Pharma Manufacturing Change or Addition
Stalevo 75 carbidopa; entacapone; levodopa Tablet;Oral Orion Pharma Manufacturing Change or Addition
Versacloz clozapine Suspension;Oral Jazz Pharms Iii Manufacturing Change or Addition
Vistaril hydroxyzine pamoate Capsule;Oral Pfizer Labeling Revision
Vistaril hydroxyzine pamoate Suspension;Oral Pfizer Labeling Revision