April-2016 FDA Drug Approval Report

by Admin Pharma Chemicals on 04-08-2016 in Drug & FDA news

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Drug Name 
and 
FDA Appl. #
Suppl. #
Active
Ingredients
Company
Approval
Type
Approval
Date
HICON
(NDA # 021305) 		039SODIUM IODIDE I-131JUBILANT DRAXIMAGEManufacturing Change or Addition04/01/2016
SODIUM IODIDE I-131
(NDA # 021305) 		039SODIUM IODIDE I-131JUBILANT DRAXIMAGEManufacturing Change or Addition04/01/2016
TINDAMAX
(NDA # 021618) 		005TINIDAZOLEMISSION PHARMAManufacturing Change or Addition04/01/2016
ROSIGLITAZONE MALEATE AND GLIMEPIRIDE
(ANDA # 078709) 		000GLIMEPIRIDE; ROSIGLITAZONE MALEATETEVA PHARMS USAApproval04/01/2016
JUBLIA
(NDA # 203567) 		005EFINACONAZOLEDOW PHARMManufacturing Change or Addition04/01/2016
TRIUMEQ
(NDA # 205551) 		006ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINEVIIV HLTHCAREManufacturing Change or Addition04/01/2016
ZYRTEC ALLERGY
(NDA # 019835) 		036CETIRIZINE HYDROCHLORIDEJ AND J CONSUMER INCManufacturing Change or Addition04/04/2016
ZYRTEC HIVES RELIEF
(NDA # 019835) 		036CETIRIZINE HYDROCHLORIDEJ AND J CONSUMER INCManufacturing Change or Addition04/04/2016
HABITROL
(NDA # 020076) 		039NICOTINEDR REDDYS LABS INCManufacturing Change or Addition04/04/2016
VAGIFEM
(NDA # 020908) 		023ESTRADIOLNOVO NORDISK INCManufacturing Change or Addition04/04/2016
ACIPHEX
(NDA # 020973) 		033RABEPRAZOLE SODIUMEISAI INCLabeling Revision04/04/2016
BOSULIF
(NDA # 203341) 		005BOSUTINIB MONOHYDRATEWYETH PHARMS INCLabeling Revision04/04/2016
ACIPHEX SPRINKLE
(NDA # 204736) 		003RABEPRAZOLE SODIUMEISAI INCLabeling Revision04/04/2016
VARUBI
(NDA # 206500) 		001ROLAPITANT HYDROCHLORIDETESARO INCManufacturing Change or Addition04/04/2016
HUMULIN N
(NDA # 018781) 		163INSULIN SUSP ISOPHANE RECOMBINANT HUMANLILLYManufacturing Change or Addition04/05/2016
HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
(NDA # 018916) 		066HEPARIN SODIUMHOSPIRALabeling Revision04/05/2016
HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
(NDA # 018916) 		069HEPARIN SODIUMHOSPIRALabeling Revision04/05/2016
HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.45%
(NDA # 018916) 		066HEPARIN SODIUMHOSPIRALabeling Revision04/05/2016
HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.45%
(NDA # 018916) 		069HEPARIN SODIUMHOSPIRALabeling Revision04/05/2016
HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.9%
(NDA # 018916) 		066HEPARIN SODIUMHOSPIRALabeling Revision04/05/2016
HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.9%
(NDA # 018916) 		069HEPARIN SODIUMHOSPIRALabeling Revision04/05/2016
HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
(NDA # 018916) 		066HEPARIN SODIUMHOSPIRALabeling Revision04/05/2016
HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
(NDA # 018916) 		069HEPARIN SODIUMHOSPIRALabeling Revision04/05/2016
HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.9%
(NDA # 018916) 		066HEPARIN SODIUMHOSPIRALabeling Revision04/05/2016
HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.9%
(NDA # 018916) 		069HEPARIN SODIUMHOSPIRALabeling Revision04/05/2016
HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
(NDA # 018916) 		066HEPARIN SODIUMHOSPIRALabeling Revision04/05/2016
HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
(NDA # 018916) 		069HEPARIN SODIUMHOSPIRALabeling Revision04/05/2016
HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
(NDA # 018916) 		066HEPARIN SODIUMHOSPIRALabeling Revision04/05/2016
HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
(NDA # 018916) 		069HEPARIN SODIUMHOSPIRALabeling Revision04/05/2016
HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
(NDA # 018916) 		066HEPARIN SODIUMHOSPIRALabeling Revision04/05/2016
HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
(NDA # 018916) 		069HEPARIN SODIUMHOSPIRALabeling Revision04/05/2016
HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.45%
(NDA # 018916) 		066HEPARIN SODIUMHOSPIRALabeling Revision04/05/2016
HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.45%
(NDA # 018916) 		069HEPARIN SODIUMHOSPIRALabeling Revision04/05/2016
HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.9%
(NDA # 018916) 		066HEPARIN SODIUMHOSPIRALabeling Revision04/05/2016
HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.9%
(NDA # 018916) 		069HEPARIN SODIUMHOSPIRALabeling Revision04/05/2016
IMODIUM A-D
(NDA # 019487) 		028LOPERAMIDE HYDROCHLORIDEJ AND J CONSUMER INCLabeling Revision04/05/2016
INOMAX
(NDA # 020845) 		018NITRIC OXIDEMALLINCKRODT HOSPLabeling Revision04/05/2016
CHILDREN'S CLARITIN
(NDA # 021891) 		021LORATADINEBAYER HEALTHCARE LLCLabeling Revision04/05/2016
NESINA
(NDA # 022271) 		005ALOGLIPTIN BENZOATETAKEDA PHARMS USAEfficacy Supplement with Clinical Data to Support04/05/2016
ONGLYZA
(NDA # 022350) 		014SAXAGLIPTIN HYDROCHLORIDEASTRAZENECA ABEfficacy Supplement with Clinical Data to Support04/05/2016
OSENI
(NDA # 022426) 		003ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDETAKEDA PHARMS USAEfficacy Supplement with Clinical Data to Support04/05/2016
EXPAREL
(NDA # 022496) 		017BUPIVACAINEPACIRA PHARMS INCManufacturing Change or Addition04/05/2016
INFLECTRA
(BLA # 125544) 		000INFLIXIMAB-DYYBCELLTRION INCApproval04/05/2016
KOMBIGLYZE XR
(NDA # 200678) 		013METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDEASTRAZENECA ABEfficacy Supplement with Clinical Data to Support04/05/2016
KAZANO
(NDA # 203414) 		003ALOGLIPTIN BENZOATE; METFORMIN HYDROCHLORIDETAKEDA PHARMS USAEfficacy Supplement with Clinical Data to Support04/05/2016
LONSURF
(NDA # 207981) 		003TIPIRACIL HYDROCHLORIDE; TRIFLURIDINETAIHO ONCOLOGYManufacturing Change or Addition04/05/2016
LOPID
(NDA # 018422) 		055GEMFIBROZILPFIZER PHARMSLabeling Revision04/06/2016
ZONEGRAN
(NDA # 020789) 		034ZONISAMIDESUNOVION PHARMS INCLabeling Revision04/06/2016
ROZEREM
(NDA # 021782) 		017RAMELTEONTAKEDA PHARMS USAManufacturing Change or Addition04/06/2016
KEPPRA XR
(NDA # 022285) 		022LEVETIRACETAMUCB INCLabeling Revision04/06/2016
BELVIQ
(NDA # 022529) 		006LORCASERIN HYDROCHLORIDEEISAI INCManufacturing Change or Addition04/06/2016
LINZESS
(NDA # 202811) 		007LINACLOTIDEFOREST LABS LLCLabeling Revision04/06/2016
ORKAMBI
(NDA # 206038) 		003IVACAFTOR; LUMACAFTORVERTEX PHARMS INCManufacturing Change or Addition04/06/2016
LOPROX
(NDA # 021159) 		022CICLOPIROXMEDICISManufacturing Change or Addition04/07/2016
STARLIX
(NDA # 021204) 		019NATEGLINIDENOVARTISManufacturing Change or Addition04/07/2016
XANAX XR
(NDA # 021434) 		015ALPRAZOLAMPHARMACIA AND UPJOHNManufacturing Change or Addition04/07/2016
ENDOMETRIN
(NDA # 022057) 		008PROGESTERONEFERRINGManufacturing Change or Addition04/07/2016
AFREZZA
(NDA # 022472) 		010INSULIN RECOMBINANT HUMANSANOFI AVENTISManufacturing Change or Addition04/07/2016
GEMCITABINE HYDROCHLORIDE
(NDA # 200795) 		006GEMCITABINE HYDROCHLORIDEHOSPIRA INCManufacturing Change or Addition04/07/201

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