Drug Safety Labeling Changes - July  2013

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Key to Label Sections

• C - Contraindications
• W - Warnings
• P - Precautions
• AR - Adverse Reactions

Drug Name	Sections Modified
	C	W	P	AR
Mometasone Furoate and Formoterol Fumarate - Inhalation Aerosol	-
Sulfasalazine - Delayed Release tablets, USP	-
Amlodipine and Olmesartan -Tablets	-		-	-
Anagrelide - Capsules	-		-
Aripiprazole - Tablets, Oral Solution, Orally Disintegrating Tablets, and Injectable Formulation	-	-		-
Asparaginase	-
Bactrim and Bactrim DS Tablets	-
Clozapine - Oral Tablets	-	-	-
Denosumab				-
Depacon (valproate sodium) Injection				-
Depakote ER (Extended Release) Tablets				-
Depakote Sprinkle Capsules (divalproex sodium coated particles in capsules)				-
Divalproex sodium Delayed Release				-
Doxycycline - Capsules	-	-	-
Ertapenem - Injection, 1 gm	-	-	-
Fluoxetine - Delayed Release Capsules	-			-
Fluoxetine - Tablets
Gadobenate- Dimeglumine - Injection and MultiHance Multipack Gadobenate Dimeglumine Injection	-			-
Guanfacine - Tablets	-	-		-
Ketoconazole - Tablets			-	-
Leuprolide - for Depot Suspension	-
Levetiracetam - Tablets, XR tablets, Oral Solution, Injection	-	-	-
Mesalamine - Controlled-Release Capsules	-			-
Naltrexone - for extended-release injectable suspension	-			-
Nifedipine - Capsules	-	-		-
Nifedipine - Tablets	-	-		-
Olanzapine and Fluoxetine - Capsules	-			-
Olmesartan	-
Olmesartan Medoxomil and Hydrochlorothiazide - Tablets	-
Olmesartan Medoxomil/ Amlodipine/ Hydrochlorothiazide - Tablets	-
Oxaliplatin - Injection	-	-	-
Silodosin - Capsules		-	-
Tapentadol - Immediate Release Oral Tablets
Tenofovir - Oral Powder, 40 mg/gram	-	-	-
Valproic acid - Capsules and Oral Solution				-
Vandetanib	-	-	-
Vemurafenib -Tablets	-
Ziprasidone - Capsules, Injection and Oral Suspension	-			-

2016 - Monthly Summary Report for Drug Label Changes

2015 - Monthly Summary Report for Drug Label Changes

2014 - Monthly Summary Report for Drug Label Changes

2013 - Monthly Summary Report for Drug Label Changes

2012 - Monthly Summary Report for Drug Label Changes