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Drugs@FDA: FDA-Approved Drugs

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All Approvals and Tentative Approvals
April 2013

This report includes approvals of NDAs, BLAs, ANDAs, and approved supplements to those applications, and tentative ANDA/NDA approvals during the selected month. This report does not include BLAs/NDAs and supplements to those applications approved by CBER.

Click on the Drug Name and Application Number to see information about the drug (for example, regulatory history, labeling, reviews by FDA staff).

This report was produced on July 15, 2026.

Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
04/01/2013 PEPCID AC
NDA #020325		 SUPPL-25 FAMOTIDINE KENVUE BRANDS Manufacturing (CMC) Approval
04/01/2013 NIMBEX
NDA #020551		 SUPPL-23 CISATRACURIUM BESYLATE ABBVIE Manufacturing (CMC) Approval
04/01/2013 NIMBEX PRESERVATIVE FREE
NDA #020551		 SUPPL-23 CISATRACURIUM BESYLATE ABBVIE Manufacturing (CMC) Approval
04/01/2013 PEPCID AC
NDA #020801		 SUPPL-16 FAMOTIDINE KENVUE BRANDS Manufacturing (CMC) Approval
04/01/2013 PEPCID COMPLETE
NDA #020958		 SUPPL-17 CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE KENVUE BRANDS Manufacturing (CMC) Approval
04/01/2013 CUTIVATE
NDA #021152		 SUPPL-7 FLUTICASONE PROPIONATE FOUGERA PHARMS Manufacturing (CMC) Approval
04/01/2013 VELCADE
NDA #021602		 SUPPL-33 BORTEZOMIB TAKEDA PHARMS USA Manufacturing (CMC) Approval
04/01/2013 NAPROXEN SODIUM
NDA #021920		 SUPPL-18 NAPROXEN SODIUM BIONPHARMA Labeling Approval
04/02/2013 LAC-HYDRIN
NDA #019155		 SUPPL-30 AMMONIUM LACTATE SUN PHARM INDS INC Manufacturing (CMC) Approval
04/02/2013 XENICAL
NDA #020766		 SUPPL-32 ORLISTAT CHEPLAPHARM Manufacturing (CMC) Approval
04/02/2013 ORFADIN
NDA #021232		 SUPPL-11 NITISINONE SWEDISH ORPHAN Manufacturing (CMC) Approval
04/02/2013 VIREAD
NDA #021356		 SUPPL-47 TENOFOVIR DISOPROXIL FUMARATE GILEAD SCIENCES INC Labeling Approval
04/02/2013 EMTRIVA
NDA #021500		 SUPPL-21 EMTRICITABINE GILEAD Labeling Approval
04/02/2013 EMTRIVA
NDA #021896		 SUPPL-18 EMTRICITABINE GILEAD Labeling Approval
04/02/2013 VERDESO
NDA #021978		 SUPPL-10 DESONIDE GENUS Labeling Approval
04/02/2013 SUPPRELIN LA
NDA #022058		 SUPPL-11 HISTRELIN ACETATE ENDO OPERATIONS Labeling Approval
04/02/2013 VIREAD
NDA #022577		 SUPPL-4 TENOFOVIR DISOPROXIL FUMARATE GILEAD SCIENCES INC Labeling Approval
04/02/2013 CYCLOBENZAPRINE HYDROCHLORIDE
ANDA #074421		 SUPPL-32 CYCLOBENZAPRINE HYDROCHLORIDE PLIVA Manufacturing (CMC) Approval
04/02/2013 LOSARTAN POTASSIUM
ANDA #090467		 SUPPL-10 LOSARTAN POTASSIUM TORRENT PHARMS Labeling Approval
04/02/2013 AZITHROMYCIN
ANDA #090923		 ORIG-1 AZITHROMYCIN SUN PHARM INDS LTD Approval
04/03/2013 METASTRON
NDA #020134		 SUPPL-10 STRONTIUM CHLORIDE SR-89 Q BIOMED Manufacturing (CMC) Approval
04/03/2013 ENABLEX
NDA #021513		 SUPPL-11 DARIFENACIN HYDROBROMIDE ABBVIE Manufacturing (CMC) Approval
04/03/2013 ELIGARD KIT
NDA #021731		 SUPPL-22 LEUPROLIDE ACETATE TOLMAR Manufacturing (CMC) Approval
04/03/2013 COARTEM
NDA #022268		 SUPPL-5 ARTEMETHER; LUMEFANTRINE NOVARTIS Manufacturing (CMC) Approval
04/03/2013 CLONAZEPAM
ANDA #074869		 SUPPL-29 CLONAZEPAM ACTAVIS ELIZABETH Labeling Approval
04/03/2013 ONDANSETRON HYDROCHLORIDE
ANDA #076967		 SUPPL-7 ONDANSETRON HYDROCHLORIDE HIKMA Labeling Approval
04/03/2013 ONDANSETRON HYDROCHLORIDE
ANDA #076967		 SUPPL-9 ONDANSETRON HYDROCHLORIDE HIKMA Labeling Approval
04/03/2013 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
ANDA #077011		 SUPPL-6 ONDANSETRON HYDROCHLORIDE HIKMA Labeling Approval
04/03/2013 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
ANDA #077011		 SUPPL-8 ONDANSETRON HYDROCHLORIDE HIKMA Labeling Approval
04/03/2013 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
ANDA #077541		 SUPPL-4 ONDANSETRON HYDROCHLORIDE HIKMA Labeling Approval
04/03/2013 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
ANDA #077541		 SUPPL-5 ONDANSETRON HYDROCHLORIDE HIKMA Labeling Approval
04/03/2013 CARBIDOPA AND LEVODOPA
ANDA #077828		 SUPPL-4 CARBIDOPA; LEVODOPA SUN PHARM INDS Labeling Approval
04/03/2013 LANSOPRAZOLE
ANDA #090331		 SUPPL-4 LANSOPRAZOLE SANDOZ Labeling Approval
04/03/2013 LANSOPRAZOLE
ANDA #090331		 SUPPL-5 LANSOPRAZOLE SANDOZ Labeling Approval
04/03/2013 AMPICILLIN SODIUM
ANDA #090884		 ORIG-1 AMPICILLIN SODIUM ACS DOBFAR SPA Approval
04/03/2013 AMPICILLIN SODIUM
ANDA #090889		 ORIG-1 AMPICILLIN SODIUM ACS DOBFAR SPA Approval
04/03/2013 ESZOPICLONE
ANDA #091103		 ORIG-1 ESZOPICLONE SUN PHARM Approval
04/03/2013 LEVETIRACETAM
ANDA #091399		 SUPPL-4 LEVETIRACETAM LUPIN LTD Labeling Approval
04/03/2013 ALDURAZYME
BLA #125058		 SUPPL-220 LARONIDASE BIOMARIN Approval
04/03/2013 XARELTO
NDA #202439		 SUPPL-3 RIVAROXABAN JANSSEN PHARMS Manufacturing (CMC) Approval
04/03/2013 ACYCLOVIR
ANDA #202459		 ORIG-1 ACYCLOVIR PHARMOBEDIENT Approval
04/04/2013 GONAL-F
BLA #020378		 SUPPL-60 FOLLITROPIN ALFA/BETA EMD SERONO Approval
04/04/2013 ARICEPT
NDA #020690		 SUPPL-31 DONEPEZIL HYDROCHLORIDE EISAI INC Labeling Approval
04/04/2013 OMNITROPE
BLA #021426		 SUPPL-23 SOMATROPIN SANDOZ Approval
04/04/2013 GONAL-F RFF REDI-JECT
BLA #021684		 SUPPL-33 FOLLITROPIN ALFA/BETA EMD SERONO Approval
04/04/2013 ARICEPT ODT
NDA #021720		 SUPPL-7 DONEPEZIL HYDROCHLORIDE EISAI INC Labeling Approval
04/04/2013 VANTAS
NDA #021732		 SUPPL-18 HISTRELIN ACETATE ENDO OPERATIONS Labeling Approval
04/04/2013 GONAL-F
BLA #021765		 SUPPL-29 FOLLITROPIN ALFA/BETA EMD SERONO Approval
04/04/2013 GONAL-F RFF
BLA #021765		 SUPPL-29 FOLLITROPIN ALFA/BETA EMD SERONO Approval
04/04/2013 ISENTRESS
NDA #022145		 SUPPL-28 RALTEGRAVIR POTASSIUM MSD SUB MERCK Labeling Approval
04/04/2013 ISENTRESS HD
NDA #022145		 SUPPL-28 RALTEGRAVIR POTASSIUM MSD SUB MERCK Labeling Approval
04/04/2013 CLOPIDOGREL BISULFATE
ANDA #091023		 SUPPL-1 CLOPIDOGREL BISULFATE DR REDDYS LABS LTD Labeling Approval
04/04/2013 ACITRETIN
ANDA #091455		 ORIG-1 ACITRETIN BARR LABS INC Approval
04/04/2013 DIFICID
NDA #201699		 SUPPL-4 FIDAXOMICIN CUBIST PHARMS LLC Labeling Approval
04/04/2013 CROMOLYN SODIUM
ANDA #202745		 ORIG-1 CROMOLYN SODIUM MICRO LABS LTD INDIA Approval
04/04/2013 ACITRETIN
ANDA #202897		 ORIG-1 ACITRETIN TEVA PHARMS USA Approval
04/04/2013 ISENTRESS
NDA #203045		 SUPPL-5 RALTEGRAVIR POTASSIUM MSD SUB MERCK Labeling Approval
04/04/2013 CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER
ANDA #203048		 ORIG-1 CLINDAMYCIN PHOSPHATE RISING Approval
04/05/2013 SAIZEN
BLA #019764		 SUPPL-69 SOMATROPIN EMD SERONO Approval
04/05/2013 GASTROMARK
NDA #020410		 SUPPL-3 FERUMOXSIL AMAG PHARMS INC Manufacturing (CMC) Approval
04/05/2013 SEROSTIM
BLA #020604		 SUPPL-73 SOMATROPIN EMD SERONO Approval
04/05/2013 SEROSTIM LQ
BLA #020604		 SUPPL-73 SOMATROPIN EMD SERONO Approval
04/05/2013 XENICAL
NDA #020766		 SUPPL-31 ORLISTAT CHEPLAPHARM Manufacturing (CMC) Approval
04/05/2013 OVIDREL
BLA #021149		 SUPPL-34 CHORIOGONADOTROPIN ALFA EMD SERONO Approval
04/05/2013 BONIVA
NDA #021455		 SUPPL-16 IBANDRONATE SODIUM HOFFMANN LA ROCHE Manufacturing (CMC) Approval
04/05/2013 STALEVO 100
NDA #021485		 SUPPL-25 CARBIDOPA; ENTACAPONE; LEVODOPA ORION PHARMA Manufacturing (CMC) Approval
04/05/2013 STALEVO 125
NDA #021485		 SUPPL-25 CARBIDOPA; ENTACAPONE; LEVODOPA ORION PHARMA Manufacturing (CMC) Approval
04/05/2013 STALEVO 150
NDA #021485		 SUPPL-25 CARBIDOPA; ENTACAPONE; LEVODOPA ORION PHARMA Manufacturing (CMC) Approval
04/05/2013 STALEVO 200
NDA #021485		 SUPPL-25 CARBIDOPA; ENTACAPONE; LEVODOPA ORION PHARMA Manufacturing (CMC) Approval
04/05/2013 STALEVO 50
NDA #021485		 SUPPL-25 CARBIDOPA; ENTACAPONE; LEVODOPA ORION PHARMA Manufacturing (CMC) Approval
04/05/2013 STALEVO 75
NDA #021485		 SUPPL-25 CARBIDOPA; ENTACAPONE; LEVODOPA ORION PHARMA Manufacturing (CMC) Approval
04/05/2013 NUVIGIL
NDA #021875		 SUPPL-18 ARMODAFINIL NUVO PHARMS Manufacturing (CMC) Approval
04/05/2013 COARTEM
NDA #022268		 SUPPL-6 ARTEMETHER; LUMEFANTRINE NOVARTIS Manufacturing (CMC) Approval
04/05/2013 NEXTERONE
NDA #022325		 SUPPL-6 AMIODARONE HYDROCHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
04/05/2013 OFIRMEV
NDA #022450		 SUPPL-3 ACETAMINOPHEN MALLINCKRODT HOSP Manufacturing (CMC) Approval
04/05/2013 CARBIDOPA AND LEVODOPA
ANDA #078536		 SUPPL-8 CARBIDOPA; LEVODOPA SUN PHARM INDS Labeling Approval
04/05/2013 ATORVASTATIN CALCIUM
ANDA #091226		 SUPPL-1 ATORVASTATIN CALCIUM MYLAN PHARMS INC Labeling Approval
04/05/2013 ATORVASTATIN CALCIUM
ANDA #091624		 ORIG-1 ATORVASTATIN CALCIUM LANNETT CO INC Approval
04/05/2013 DOCETAXEL
NDA #201195		 SUPPL-4 DOCETAXEL ACCORD HLTHCARE Manufacturing (CMC) Approval
04/05/2013 LANSOPRAZOLE
ANDA #202319		 SUPPL-5 LANSOPRAZOLE PERRIGO R AND D Labeling Approval
04/05/2013 LANSOPRAZOLE
ANDA #202319		 SUPPL-6 LANSOPRAZOLE PERRIGO R AND D Labeling Approval
04/05/2013 ZOLEDRONIC ACID
ANDA #202837		 ORIG-1 ZOLEDRONIC ACID HOSPIRA INC Approval
04/05/2013 PROLENSA
NDA #203168		 ORIG-1 BROMFENAC SODIUM BAUSCH AND LOMB Type 5 - New Formulation or New Manufacturer Approval
04/08/2013 CYTOVENE
NDA #019661		 SUPPL-34 GANCICLOVIR SODIUM CHEPLAPHARM Manufacturing (CMC) Approval
04/08/2013 DICLEGIS
NDA #021876		 ORIG-1 DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE DUCHESNAY Type 5 - New Formulation or New Manufacturer Approval
04/08/2013 ENDOMETRIN
NDA #022057		 SUPPL-5 PROGESTERONE FERRING Manufacturing (CMC) Approval
04/08/2013 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
ANDA #077551		 SUPPL-3 ONDANSETRON HYDROCHLORIDE SANDOZ Labeling Approval
04/08/2013 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
ANDA #077551		 SUPPL-5 ONDANSETRON HYDROCHLORIDE SANDOZ Labeling Approval
04/08/2013 ANASTROZOLE
ANDA #078058		 SUPPL-5 ANASTROZOLE TEVA PHARMS Labeling Approval
04/08/2013 LEVOFLOXACIN
ANDA #078424		 SUPPL-8 LEVOFLOXACIN LUPIN Labeling Approval
04/08/2013 RISPERIDONE
ANDA #078464		 ORIG-1 RISPERIDONE SUN PHARM INDS LTD Approval
04/08/2013 ANASTROZOLE
ANDA #090568		 SUPPL-5 ANASTROZOLE ACCORD HLTHCARE Labeling Approval
04/08/2013 NULOJIX
BLA #125288		 SUPPL-30 BELATACEPT BRISTOL MYERS SQUIBB Approval
04/08/2013 NITHIODOTE
NDA #201444		 SUPPL-10 SODIUM NITRITE; SODIUM THIOSULFATE HOPE PHARMS Manufacturing (CMC) Approval
04/09/2013 XYLOCAINE
NDA #006488		 SUPPL-78 LIDOCAINE HYDROCHLORIDE FRESENIUS KABI USA Manufacturing (CMC) Approval
04/09/2013 XYLOCAINE W/ EPINEPHRINE
NDA #006488		 SUPPL-78 EPINEPHRINE; LIDOCAINE HYDROCHLORIDE FRESENIUS KABI USA Manufacturing (CMC) Approval
04/09/2013 PERIDEX
NDA #019028		 SUPPL-21 CHLORHEXIDINE GLUCONATE SOLVENTUM Manufacturing (CMC) Approval
04/09/2013 ACCUPRIL
NDA #019885		 SUPPL-37 QUINAPRIL HYDROCHLORIDE PFIZER PHARMS Labeling Approval
04/09/2013 ELIGARD KIT
NDA #021343		 SUPPL-26 LEUPROLIDE ACETATE TOLMAR Manufacturing (CMC) Approval
04/09/2013 DUODOTE
NDA #021983		 SUPPL-11 ATROPINE; PRALIDOXIME CHLORIDE MMT Manufacturing (CMC) Approval
04/09/2013 SAMSCA
NDA #022275		 SUPPL-9 TOLVAPTAN OTSUKA Labeling Approval
04/09/2013 CONZIP
NDA #022370		 SUPPL-8 TRAMADOL HYDROCHLORIDE CIPHER PHARMS INC Manufacturing (CMC) Approval
04/09/2013 GRALISE
NDA #022544		 SUPPL-17 GABAPENTIN ALMATICA Manufacturing (CMC) Approval
04/09/2013 CLINDESSE
NDA #050793		 SUPPL-18 CLINDAMYCIN PHOSPHATE PADAGIS US Manufacturing (CMC) Approval
04/09/2013 GABAPENTIN
ANDA #077661		 SUPPL-9 GABAPENTIN RUBICON RESEARCH REMS Approval
04/10/2013 SURVANTA
BLA #020032		 SUPPL-41 BERACTANT ABBVIE Approval
04/10/2013 PULMICORT RESPULES
NDA #020929		 SUPPL-50 BUDESONIDE ASTRAZENECA Manufacturing (CMC) Approval
04/10/2013 LEVEMIR
BLA #021536		 SUPPL-44 INSULIN DETEMIR RECOMBINANT NOVO NORDISK INC Approval
04/10/2013 LEVEMIR FLEXPEN
BLA #021536		 SUPPL-44 INSULIN DETEMIR RECOMBINANT NOVO NORDISK INC Approval
04/10/2013 LEVEMIR FLEXTOUCH
BLA #021536		 SUPPL-44 INSULIN DETEMIR RECOMBINANT NOVO NORDISK INC Approval
04/10/2013 LEVEMIR INNOLET
BLA #021536		 SUPPL-44 INSULIN DETEMIR RECOMBINANT NOVO NORDISK INC Approval
04/10/2013 LEVEMIR PENFILL
BLA #021536		 SUPPL-44 INSULIN DETEMIR RECOMBINANT NOVO NORDISK INC Approval
04/10/2013 SURFAXIN
NDA #021746		 SUPPL-2 LUCINACTANT LEES PHARM HK Manufacturing (CMC) Approval
04/10/2013 CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER
NDA #050796		 SUPPL-17 CEFTRIAXONE SODIUM B BRAUN Labeling Approval
04/10/2013 ONDANSETRON HYDROCHLORIDE
ANDA #077430		 SUPPL-3 ONDANSETRON HYDROCHLORIDE SANDOZ Labeling Approval
04/10/2013 RISPERIDONE
ANDA #078116		 SUPPL-10 RISPERIDONE SANDOZ Labeling Approval
04/10/2013 DAYSEE
ANDA #091467		 ORIG-1 ETHINYL ESTRADIOL; LEVONORGESTREL LUPIN LTD Approval
04/10/2013 KALBITOR
BLA #125277		 SUPPL-65 ECALLANTIDE DYAX CORP. Approval
04/10/2013 PREDNISOLONE SODIUM PHOSPHATE
ANDA #202179		 ORIG-1 PREDNISOLONE SODIUM PHOSPHATE RISING Approval
04/10/2013 JANUMET XR
NDA #202270		 SUPPL-1 METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE MSD SUB MERCK Manufacturing (CMC) Approval
04/10/2013 JUXTAPID
NDA #203858		 SUPPL-2 LOMITAPIDE MESYLATE CHIESI Labeling Approval
04/11/2013 FLEXERIL
NDA #017821		 SUPPL-51 CYCLOBENZAPRINE HYDROCHLORIDE JANSSEN RES AND DEV Labeling Approval
04/11/2013 EXIDINE
NDA #019127		 SUPPL-20 CHLORHEXIDINE GLUCONATE XTTRIUM Labeling Approval
04/11/2013 ZINECARD
NDA #020212		 SUPPL-15 DEXRAZOXANE HYDROCHLORIDE PFIZER Manufacturing (CMC) Approval
04/11/2013 TRELSTAR
NDA #020715		 SUPPL-28 TRIPTORELIN PAMOATE VERITY Manufacturing (CMC) Approval
04/11/2013 OVIDREL
BLA #021149		 SUPPL-35 CHORIOGONADOTROPIN ALFA EMD SERONO Approval
04/11/2013 AMRIX
NDA #021777		 SUPPL-12 CYCLOBENZAPRINE HYDROCHLORIDE TEVA PHARMS INTL Labeling Approval
04/11/2013 ZENPEP
BLA #022210		 SUPPL-9 PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) EURAND PHARMA LTD Approval
04/11/2013 ZENPEP
BLA #022210		 SUPPL-12 PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) EURAND PHARMA LTD Approval
04/11/2013 TRELSTAR
NDA #022437		 SUPPL-5 TRIPTORELIN PAMOATE VERITY Manufacturing (CMC) Approval
04/11/2013 DORYX
NDA #050795		 SUPPL-10 DOXYCYCLINE HYCLATE MAYNE PHARMA Efficacy Approval
04/11/2013 DORYX
NDA #050795		 SUPPL-11 DOXYCYCLINE HYCLATE MAYNE PHARMA Manufacturing (CMC) Approval
04/11/2013 DORYX MPC
NDA #050795		 SUPPL-10 DOXYCYCLINE HYCLATE MAYNE PHARMA Efficacy Approval
04/11/2013 DORYX MPC
NDA #050795		 SUPPL-11 DOXYCYCLINE HYCLATE MAYNE PHARMA Manufacturing (CMC) Approval
04/11/2013 CYCLOBENZAPRINE HYDROCHLORIDE
ANDA #071611		 SUPPL-69 CYCLOBENZAPRINE HYDROCHLORIDE ACTAVIS LABS FL INC Labeling Approval
04/11/2013 CYCLOBENZAPRINE HYDROCHLORIDE
ANDA #073144		 SUPPL-25 CYCLOBENZAPRINE HYDROCHLORIDE RISING Labeling Approval
04/11/2013 CYCLOBENZAPRINE HYDROCHLORIDE
ANDA #073541		 SUPPL-15 CYCLOBENZAPRINE HYDROCHLORIDE TP ANDA HOLDINGS Labeling Approval
04/11/2013 CYCLOBENZAPRINE HYDROCHLORIDE
ANDA #074421		 SUPPL-33 CYCLOBENZAPRINE HYDROCHLORIDE PLIVA Labeling Approval
04/11/2013 CYCLOBENZAPRINE HYDROCHLORIDE
ANDA #077563		 SUPPL-5 CYCLOBENZAPRINE HYDROCHLORIDE JUBILANT CADISTA Labeling Approval
04/11/2013 CYCLOBENZAPRINE HYDROCHLORIDE
ANDA #077797		 SUPPL-10 CYCLOBENZAPRINE HYDROCHLORIDE PRINSTON INC Labeling Approval
04/11/2013 CYCLOBENZAPRINE HYDROCHLORIDE
ANDA #078048		 SUPPL-2 CYCLOBENZAPRINE HYDROCHLORIDE KVK TECH Labeling Approval
04/11/2013 CYCLOBENZAPRINE HYDROCHLORIDE
ANDA #078218		 SUPPL-6 CYCLOBENZAPRINE HYDROCHLORIDE CHARTWELL RX Labeling Approval
04/11/2013 CYCLOBENZAPRINE HYDROCHLORIDE
ANDA #078643		 SUPPL-4 CYCLOBENZAPRINE HYDROCHLORIDE AUROBINDO PHARMA Labeling Approval
04/11/2013 CYCLOBENZAPRINE HYDROCHLORIDE
ANDA #078722		 SUPPL-3 CYCLOBENZAPRINE HYDROCHLORIDE SUN PHARM INDS LTD Labeling Approval
04/11/2013 CYCLOBENZAPRINE HYDROCHLORIDE
ANDA #090478		 SUPPL-1 CYCLOBENZAPRINE HYDROCHLORIDE INVAGEN PHARMS Labeling Approval
04/11/2013 Xeomin
BLA #125360		 SUPPL-45 incobotulinumtoxinA MERZ PHARMS Approval
04/11/2013 SITAGLIPTIN PHOSPHATE
ANDA #202423		 ORIG-1 SITAGLIPTIN PHOSPHATE SUN PHARMA GLOBAL Tentative Approval
04/11/2013 TOPICORT
NDA #204141		 ORIG-1 DESOXIMETASONE SUN PHARMA CANADA Type 3 - New Dosage Form Approval
04/12/2013 COLGATE TOTAL
NDA #020231		 SUPPL-71 SODIUM FLUORIDE; TRICLOSAN COLGATE PALMOLIVE Manufacturing (CMC) Approval
04/12/2013 ORTHO EVRA
NDA #021180		 SUPPL-37 ETHINYL ESTRADIOL; NORELGESTROMIN JANSSEN PHARMS Manufacturing (CMC) Approval
04/12/2013 ORTHO EVRA
NDA #021180		 SUPPL-41 ETHINYL ESTRADIOL; NORELGESTROMIN JANSSEN PHARMS Manufacturing (CMC) Approval
04/12/2013 ROCEPHIN
NDA #050585		 SUPPL-65 CEFTRIAXONE SODIUM HOFFMANN LA ROCHE Labeling Approval
04/12/2013 ROCEPHIN KIT
NDA #050585		 SUPPL-65 CEFTRIAXONE SODIUM; LIDOCAINE HOFFMANN LA ROCHE Labeling Approval
04/12/2013 LAMOTRIGINE
ANDA #078691		 SUPPL-3 LAMOTRIGINE LUPIN LTD Labeling Approval
04/12/2013 OXCARBAZEPINE
ANDA #078734		 SUPPL-6 OXCARBAZEPINE SUN PHARM INDS LTD Labeling Approval
04/12/2013 LEVETIRACETAM
ANDA #090893		 SUPPL-3 LEVETIRACETAM LUPIN LTD Labeling Approval
04/12/2013 PERJETA
BLA #125409		 SUPPL-32 PERTUZUMAB GENENTECH Approval
04/12/2013 OXYCODONE AND ACETAMINOPHEN
ANDA #201447		 ORIG-1 ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE ACTAVIS ELIZABETH Approval
04/12/2013 VASCEPA
NDA #202057		 SUPPL-3 ICOSAPENT ETHYL AMARIN PHARMS Manufacturing (CMC) Approval
04/12/2013 DOCETAXEL
NDA #203551		 ORIG-1 DOCETAXEL ACTAVIS Type 5 - New Formulation or New Manufacturer Approval
04/12/2013 SITAVIG
NDA #203791		 ORIG-1 ACYCLOVIR LIGAND PHARMS Type 3 - New Dosage Form Approval
04/13/2013 QUALAQUIN
NDA #021799		 SUPPL-23 QUININE SULFATE SUN PHARM INDUSTRIES Labeling Approval
04/15/2013 DOLOPHINE HYDROCHLORIDE
NDA #006134		 SUPPL-32 METHADONE HYDROCHLORIDE HIKMA REMS Approval
04/15/2013 MS CONTIN
NDA #019516		 SUPPL-38 MORPHINE SULFATE KNOA PHARMA REMS Approval
04/15/2013 DURAGESIC-100
NDA #019813		 SUPPL-56 FENTANYL JANSSEN PHARMS REMS Approval
04/15/2013 DURAGESIC-12
NDA #019813		 SUPPL-56 FENTANYL JANSSEN PHARMS REMS Approval
04/15/2013 DURAGESIC-25
NDA #019813		 SUPPL-56 FENTANYL JANSSEN PHARMS REMS Approval
04/15/2013 DURAGESIC-37
NDA #019813		 SUPPL-56 FENTANYL JANSSEN PHARMS REMS Approval
04/15/2013 DURAGESIC-50
NDA #019813		 SUPPL-56 FENTANYL JANSSEN PHARMS REMS Approval
04/15/2013 DURAGESIC-75
NDA #019813		 SUPPL-56 FENTANYL JANSSEN PHARMS REMS Approval
04/15/2013 KADIAN
NDA #020616		 SUPPL-47 MORPHINE SULFATE ALLERGAN REMS Approval
04/15/2013 CUROSURF
BLA #020744		 SUPPL-25 PORACTANT ALFA CHIESI USA INC Approval
04/15/2013 CUROSURF
BLA #020744		 SUPPL-26 PORACTANT ALFA CHIESI USA INC Approval
04/15/2013 EXALGO
NDA #021217		 SUPPL-6 HYDROMORPHONE HYDROCHLORIDE SPECGX LLC REMS Approval
04/15/2013 AVINZA
NDA #021260		 SUPPL-18 MORPHINE SULFATE KING PHARMS LLC Labeling Approval
04/15/2013 BUTRANS
NDA #021306		 SUPPL-12 BUPRENORPHINE KNOA PHARMA REMS Approval
04/15/2013 INSPRA
NDA #021437		 SUPPL-10 EPLERENONE UPJOHN Manufacturing (CMC) Approval
04/15/2013 OPANA ER
NDA #021610		 SUPPL-14 OXYMORPHONE HYDROCHLORIDE ENDO OPERATIONS REMS Approval
04/15/2013 DORIBAX
NDA #022106		 SUPPL-7 DORIPENEM SHIONOGI Labeling Approval
04/15/2013 DORIBAX
NDA #022106		 SUPPL-8 DORIPENEM SHIONOGI Labeling Approval
04/15/2013 DORIBAX
NDA #022106		 SUPPL-9 DORIPENEM SHIONOGI Labeling Approval
04/15/2013 DORIBAX
NDA #022106		 SUPPL-14 DORIPENEM SHIONOGI Labeling Approval
04/15/2013 OXYCONTIN
NDA #022272		 SUPPL-17 OXYCODONE HYDROCHLORIDE KNOA PHARMA REMS Approval
04/15/2013 EMBEDA
NDA #022321		 SUPPL-10 MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE ALPHARMA PHARMS REMS Approval
04/15/2013 ALSUMA
NDA #022377		 SUPPL-3 SUMATRIPTAN SUCCINATE MERIDIAN MEDCL Manufacturing (CMC) Approval
04/15/2013 METHADOSE
ANDA #040050		 SUPPL-14 METHADONE HYDROCHLORIDE SPECGX LLC REMS Approval
04/15/2013 METHADONE HYDROCHLORIDE
ANDA #040241		 SUPPL-8 METHADONE HYDROCHLORIDE VISTAPHARM LLC REMS Approval
04/15/2013 METHADONE HYDROCHLORIDE
ANDA #040517		 SUPPL-9 METHADONE HYDROCHLORIDE SPECGX LLC REMS Approval
04/15/2013 MORPHINE SULFATE
ANDA #074769		 SUPPL-13 MORPHINE SULFATE RHODES PHARMS REMS Approval
04/15/2013 MORPHINE SULFATE
ANDA #074862		 SUPPL-13 MORPHINE SULFATE RHODES PHARMS REMS Approval
04/15/2013 FENTANYL-100
ANDA #076258		 SUPPL-22 FENTANYL MYLAN TECHNOLOGIES REMS Approval
04/15/2013 FENTANYL-12
ANDA #076258		 SUPPL-22 FENTANYL MYLAN TECHNOLOGIES REMS Approval
04/15/2013 FENTANYL-25
ANDA #076258		 SUPPL-22 FENTANYL MYLAN TECHNOLOGIES REMS Approval
04/15/2013 FENTANYL-37
ANDA #076258		 SUPPL-22 FENTANYL MYLAN TECHNOLOGIES REMS Approval
04/15/2013 FENTANYL-50
ANDA #076258		 SUPPL-22 FENTANYL MYLAN TECHNOLOGIES REMS Approval
04/15/2013 FENTANYL-62
ANDA #076258		 SUPPL-22 FENTANYL MYLAN TECHNOLOGIES REMS Approval
04/15/2013 FENTANYL-75
ANDA #076258		 SUPPL-22 FENTANYL MYLAN TECHNOLOGIES REMS Approval
04/15/2013 FENTANYL-87
ANDA #076258		 SUPPL-22 FENTANYL MYLAN TECHNOLOGIES REMS Approval
04/15/2013 MORPHINE SULFATE
ANDA #076412		 SUPPL-14 MORPHINE SULFATE SPECGX LLC REMS Approval
04/15/2013 MORPHINE SULFATE
ANDA #076438		 SUPPL-12 MORPHINE SULFATE SPECGX LLC REMS Approval
04/15/2013 FENTANYL-100
ANDA #076709		 SUPPL-18 FENTANYL ACTAVIS LABS UT INC REMS Approval
04/15/2013 FENTANYL-25
ANDA #076709		 SUPPL-18 FENTANYL ACTAVIS LABS UT INC REMS Approval
04/15/2013 FENTANYL-50
ANDA #076709		 SUPPL-18 FENTANYL ACTAVIS LABS UT INC REMS Approval
04/15/2013 FENTANYL-75
ANDA #076709		 SUPPL-18 FENTANYL ACTAVIS LABS UT INC REMS Approval
04/15/2013 FENTANYL-100
ANDA #077062		 SUPPL-19 FENTANYL MAYNE PHARMA Labeling Approval
04/15/2013 FENTANYL-25
ANDA #077062		 SUPPL-19 FENTANYL MAYNE PHARMA Labeling Approval
04/15/2013 FENTANYL-50
ANDA #077062		 SUPPL-19 FENTANYL MAYNE PHARMA Labeling Approval
04/15/2013 FENTANYL-75
ANDA #077062		 SUPPL-19 FENTANYL MAYNE PHARMA Labeling Approval
04/15/2013 FENTANYL-100
ANDA #077154		 SUPPL-6 FENTANYL SPECGX LLC REMS Approval
04/15/2013 FENTANYL-12
ANDA #077154		 SUPPL-6 FENTANYL SPECGX LLC REMS Approval
04/15/2013 FENTANYL-25
ANDA #077154		 SUPPL-6 FENTANYL SPECGX LLC REMS Approval
04/15/2013 FENTANYL-37
ANDA #077154		 SUPPL-6 FENTANYL SPECGX LLC REMS Approval
04/15/2013 FENTANYL-50
ANDA #077154		 SUPPL-6 FENTANYL SPECGX LLC REMS Approval
04/15/2013 FENTANYL-62
ANDA #077154		 SUPPL-6 FENTANYL SPECGX LLC REMS Approval
04/15/2013 FENTANYL-75
ANDA #077154		 SUPPL-6 FENTANYL SPECGX LLC REMS Approval
04/15/2013 FENTANYL-100
ANDA #077775		 SUPPL-11 FENTANYL NOVEN REMS Approval
04/15/2013 FENTANYL-25
ANDA #077775		 SUPPL-11 FENTANYL NOVEN REMS Approval
04/15/2013 FENTANYL-50
ANDA #077775		 SUPPL-11 FENTANYL NOVEN REMS Approval
04/15/2013 FENTANYL-75
ANDA #077775		 SUPPL-11 FENTANYL NOVEN REMS Approval
04/15/2013 MORPHINE SULFATE
ANDA #078761		 SUPPL-2 MORPHINE SULFATE SUN PHARM INDS LTD Labeling Approval
04/15/2013 MORPHINE SULFATE
ANDA #079040		 SUPPL-3 MORPHINE SULFATE ACTAVIS ELIZABETH REMS Approval
04/15/2013 OXYMORPHONE HYDROCHLORIDE
ANDA #079046		 SUPPL-8 OXYMORPHONE HYDROCHLORIDE ACTAVIS ELIZABETH REMS Approval
04/15/2013 OXYMORPHONE HYDROCHLORIDE
ANDA #079087		 SUPPL-6 OXYMORPHONE HYDROCHLORIDE IMPAX LABS REMS Approval
04/15/2013 METHADONE HYDROCHLORIDE
ANDA #087393		 SUPPL-32 METHADONE HYDROCHLORIDE HIKMA REMS Approval
04/15/2013 METHADONE HYDROCHLORIDE
ANDA #087997		 SUPPL-23 METHADONE HYDROCHLORIDE HIKMA REMS Approval
04/15/2013 METHADONE HYDROCHLORIDE INTENSOL
ANDA #089897		 SUPPL-27 METHADONE HYDROCHLORIDE HIKMA REMS Approval
04/15/2013 METHADONE HYDROCHLORIDE
ANDA #090635		 SUPPL-5 METHADONE HYDROCHLORIDE THEPHARMANETWORK LLC REMS Approval
04/15/2013 METHADONE HYDROCHLORIDE
ANDA #090707		 SUPPL-2 METHADONE HYDROCHLORIDE VISTAPHARM LLC REMS Approval
04/15/2013 NUCYNTA ER
NDA #200533		 SUPPL-4 TAPENTADOL HYDROCHLORIDE COLLEGIUM PHARM INC REMS Approval
04/15/2013 MORPHINE SULFATE
ANDA #200824		 SUPPL-4 MORPHINE SULFATE RISING REMS Approval
04/15/2013 OPANA ER
NDA #201655		 SUPPL-5 OXYMORPHONE HYDROCHLORIDE ENDO PHARMS REMS Approval
04/15/2013 GLYCOPYRROLATE
ANDA #202675		 ORIG-1 GLYCOPYRROLATE AUROBINDO PHARMA Approval
04/15/2013 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #202800		 ORIG-1 ACETAMINOPHEN; CODEINE PHOSPHATE AUROLIFE PHARMA LLC Approval
04/16/2013 CLARITIN
NDA #020641		 SUPPL-33 LORATADINE BAYER HEALTHCARE LLC Manufacturing (CMC) Approval
04/16/2013 CLARITIN HIVES RELIEF
NDA #020641		 SUPPL-33 LORATADINE BAYER HEALTHCARE LLC Manufacturing (CMC) Approval
04/16/2013 ALLEGRA ALLERGY
NDA #020872		 SUPPL-30 FEXOFENADINE HYDROCHLORIDE CHATTEM SANOFI Manufacturing (CMC) Approval
04/16/2013 ALLEGRA HIVES
NDA #020872		 SUPPL-30 FEXOFENADINE HYDROCHLORIDE CHATTEM SANOFI Manufacturing (CMC) Approval
04/16/2013 CHILDREN'S ALLEGRA ALLERGY
NDA #020872		 SUPPL-30 FEXOFENADINE HYDROCHLORIDE CHATTEM SANOFI Manufacturing (CMC) Approval
04/16/2013 CHILDREN'S ALLEGRA HIVES
NDA #020872		 SUPPL-30 FEXOFENADINE HYDROCHLORIDE CHATTEM SANOFI Manufacturing (CMC) Approval
04/16/2013 BARACLUDE
NDA #021797		 SUPPL-15 ENTECAVIR BRISTOL MYERS SQUIBB Manufacturing (CMC) Approval
04/16/2013 OXYCONTIN
NDA #022272		 SUPPL-14 OXYCODONE HYDROCHLORIDE KNOA PHARMA Efficacy Approval
04/16/2013 VICTOZA
NDA #022341		 SUPPL-18 LIRAGLUTIDE NOVO NORDISK INC Labeling Approval
04/16/2013 QSYMIA
NDA #022580		 SUPPL-4 PHENTERMINE HYDROCHLORIDE; TOPIRAMATE VIVUS LLC REMS Approval
04/16/2013 RISPERIDONE
ANDA #078516		 SUPPL-7 RISPERIDONE ZYDUS PHARMS USA Labeling Approval
04/16/2013 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE
ANDA #091273		 ORIG-1 METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE CHARTWELL RX Approval
04/17/2013 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #020255		 SUPPL-16 DOBUTAMINE HYDROCHLORIDE BAXTER HLTHCARE Labeling Approval
04/17/2013 FORADIL
NDA #020831		 SUPPL-31 FORMOTEROL FUMARATE NOVARTIS Manufacturing (CMC) Approval
04/17/2013 ATRIPLA
NDA #021937		 SUPPL-27 EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE GILEAD SCIENCES Labeling Approval
04/17/2013 VIMPAT
NDA #022253		 SUPPL-24 LACOSAMIDE UCB INC Labeling Approval
04/17/2013 VIMPAT
NDA #022254		 SUPPL-18 LACOSAMIDE UCB INC Labeling Approval
04/17/2013 VIMPAT
NDA #022255		 SUPPL-10 LACOSAMIDE UCB INC Labeling Approval
04/17/2013 SOLODYN
NDA #050808		 SUPPL-20 MINOCYCLINE HYDROCHLORIDE BAUSCH Manufacturing (CMC) Approval
04/17/2013 GLIMEPIRIDE
ANDA #202112		 ORIG-1 GLIMEPIRIDE REGCON HOLDINGS Approval
04/17/2013 BINOSTO
NDA #202344		 SUPPL-4 ALENDRONATE SODIUM RADIUS Manufacturing (CMC) Approval
04/18/2013 XYLOCAINE PRESERVATIVE FREE
NDA #016801		 SUPPL-42 LIDOCAINE HYDROCHLORIDE FRESENIUS KABI USA Manufacturing (CMC) Approval
04/18/2013 DELFLEX W/ DEXTROSE 1.5% IN PLASTIC CONTAINER
NDA #018883		 SUPPL-48 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE FRESENIUS MEDCL Manufacturing (CMC) Approval
04/18/2013 DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM IN PLASTIC CONTAINER
NDA #018883		 SUPPL-48 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE FRESENIUS MEDCL Manufacturing (CMC) Approval
04/18/2013 DELFLEX W/ DEXTROSE 2.5% IN PLASTIC CONTAINER
NDA #018883		 SUPPL-48 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE FRESENIUS MEDCL Manufacturing (CMC) Approval
04/18/2013 DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM IN PLASTIC CONTAINER
NDA #018883		 SUPPL-48 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE FRESENIUS MEDCL Manufacturing (CMC) Approval
04/18/2013 DELFLEX W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
NDA #018883		 SUPPL-48 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE FRESENIUS MEDCL Manufacturing (CMC) Approval
04/18/2013 DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM IN PLASTIC CONTAINER
NDA #018883		 SUPPL-48 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE FRESENIUS MEDCL Manufacturing (CMC) Approval
04/18/2013 DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER
NDA #020171		 SUPPL-30 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE FRESENIUS MEDCL Manufacturing (CMC) Approval
04/18/2013 DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER
NDA #020171		 SUPPL-30 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE FRESENIUS MEDCL Manufacturing (CMC) Approval
04/18/2013 DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER
NDA #020171		 SUPPL-30 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE FRESENIUS MEDCL Manufacturing (CMC) Approval
04/18/2013 ALEVE
NDA #020204		 SUPPL-44 NAPROXEN SODIUM BAYER Labeling Approval
04/18/2013 CLARITHROMYCIN
ANDA #065283		 SUPPL-9 CLARITHROMYCIN SANDOZ Labeling Approval
04/18/2013 ZONISAMIDE
ANDA #077876		 SUPPL-2 ZONISAMIDE EPIC PHARMA LLC Labeling Approval
04/18/2013 PRAVASTATIN SODIUM
ANDA #077917		 SUPPL-15 PRAVASTATIN SODIUM CHARTWELL RX Labeling Approval
04/19/2013 VALIUM
NDA #013263		 SUPPL-91 DIAZEPAM WAYLIS THERAP Manufacturing (CMC) Approval
04/19/2013 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #016733		 SUPPL-53 SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
04/19/2013 DIANEAL 137 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-113 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE VANTIVE US HLTHCARE Labeling Approval
04/19/2013 DIANEAL 137 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-113 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE VANTIVE US HLTHCARE Labeling Approval
04/19/2013 DIANEAL 137 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-113 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE VANTIVE US HLTHCARE Labeling Approval
04/19/2013 DIANEAL LOW CALCIUM W/DEXTROSE 1.5% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-113 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE VANTIVE US HLTHCARE Labeling Approval
04/19/2013 DIANEAL LOW CALCIUM W/DEXTROSE 2.5% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-113 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE VANTIVE US HLTHCARE Labeling Approval
04/19/2013 DIANEAL LOW CALCIUM W/DEXTROSE 3.5% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-113 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE VANTIVE US HLTHCARE Labeling Approval
04/19/2013 DIANEAL LOW CALCIUM W/DEXTROSE 4.25% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-113 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE VANTIVE US HLTHCARE Labeling Approval
04/19/2013 DIANEAL PD-1 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-113 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE VANTIVE US HLTHCARE Labeling Approval
04/19/2013 DIANEAL PD-1 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-113 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE VANTIVE US HLTHCARE Labeling Approval
04/19/2013 DIANEAL PD-1 W/ DEXTROSE 3.5% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-113 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE VANTIVE US HLTHCARE Labeling Approval
04/19/2013 DIANEAL PD-1 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-113 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE VANTIVE US HLTHCARE Labeling Approval
04/19/2013 DIANEAL PD-2 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-113 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE VANTIVE US HLTHCARE Labeling Approval
04/19/2013 DIANEAL PD-2 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-113 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE VANTIVE US HLTHCARE Labeling Approval
04/19/2013 DIANEAL PD-2 W/ DEXTROSE 3.5% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-113 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE VANTIVE US HLTHCARE Labeling Approval
04/19/2013 DIANEAL PD-2 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-113 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE VANTIVE US HLTHCARE Labeling Approval
04/19/2013 DIDRONEL
NDA #017831		 SUPPL-56 ETIDRONATE DISODIUM APIL Labeling Approval
04/19/2013 DORAL
NDA #018708		 SUPPL-20 QUAZEPAM GALT PHARMS Labeling Approval
04/19/2013 DORAL
NDA #018708		 SUPPL-21 QUAZEPAM GALT PHARMS Manufacturing (CMC) Approval
04/19/2013 ELOCON
NDA #019625		 SUPPL-24 MOMETASONE FUROATE ORGANON Efficacy Approval
04/19/2013 PROMETRIUM
NDA #019781		 SUPPL-18 PROGESTERONE ACERTIS PHARMS Manufacturing (CMC) Approval
04/19/2013 AMBIEN
NDA #019908		 SUPPL-32 ZOLPIDEM TARTRATE COSETTE Labeling Approval
04/19/2013 AMBIEN
NDA #019908		 SUPPL-34 ZOLPIDEM TARTRATE COSETTE Labeling Approval
04/19/2013 DIANEAL PD-2 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER
NDA #020163		 SUPPL-20 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE VANTIVE US HLTHCARE Labeling Approval
04/19/2013 DIANEAL PD-2 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER
NDA #020163		 SUPPL-20 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE VANTIVE US HLTHCARE Labeling Approval
04/19/2013 DIANEAL PD-2 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
NDA #020163		 SUPPL-20 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE VANTIVE US HLTHCARE Labeling Approval
04/19/2013 DIANEAL LOW CALCIUM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER
NDA #020183		 SUPPL-19 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE VANTIVE US HLTHCARE Labeling Approval
04/19/2013 DIANEAL LOW CALCIUM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER
NDA #020183		 SUPPL-19 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE VANTIVE US HLTHCARE Labeling Approval
04/19/2013 DIANEAL LOW CALCIUM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER
NDA #020183		 SUPPL-19 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE VANTIVE US HLTHCARE Labeling Approval
04/19/2013 DIANEAL LOW CALCIUM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
NDA #020183		 SUPPL-19 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE VANTIVE US HLTHCARE Labeling Approval
04/19/2013 GENOTROPIN
BLA #020280		 SUPPL-74 SOMATROPIN PHARMACIA Approval
04/19/2013 GENOTROPIN PRESERVATIVE FREE
BLA #020280		 SUPPL-74 SOMATROPIN PHARMACIA Approval
04/19/2013 AMARYL
NDA #020496		 SUPPL-25 GLIMEPIRIDE SANOFI AVENTIS US Manufacturing (CMC) Approval
04/19/2013 FOSAMAX
NDA #020560		 SUPPL-65 ALENDRONATE SODIUM ORGANON Labeling Approval
04/19/2013 ACTONEL
NDA #020835		 SUPPL-45 RISEDRONATE SODIUM APIL Labeling Approval
04/19/2013 SONATA
NDA #020859		 SUPPL-13 ZALEPLON PFIZER Labeling Approval
04/19/2013 ACIPHEX
NDA #020973		 SUPPL-32 RABEPRAZOLE SODIUM WAYLIS THERAP Labeling Approval
04/19/2013 LOTRONEX
NDA #021107		 SUPPL-21 ALOSETRON HYDROCHLORIDE LEGACY Manufacturing (CMC) Approval
04/19/2013 DEMEROL
NDA #021171		 SUPPL-20 MEPERIDINE HYDROCHLORIDE HOSPIRA Manufacturing (CMC) Approval
04/19/2013 BONIVA
NDA #021455		 SUPPL-14 IBANDRONATE SODIUM HOFFMANN LA ROCHE Labeling Approval
04/19/2013 BONIVA
NDA #021455		 SUPPL-15 IBANDRONATE SODIUM HOFFMANN LA ROCHE Labeling Approval
04/19/2013 MYCAMINE
NDA #021506		 SUPPL-14 MICAFUNGIN SODIUM ASTELLAS Labeling Approval
04/19/2013 FOSAMAX
NDA #021575		 SUPPL-22 ALENDRONATE SODIUM MERCK Labeling Approval
04/19/2013 FOSAMAX PLUS D
NDA #021762		 SUPPL-17 ALENDRONATE SODIUM; CHOLECALCIFEROL ORGANON LLC Labeling Approval
04/19/2013 AMBIEN CR
NDA #021774		 SUPPL-13 ZOLPIDEM TARTRATE COSETTE Labeling Approval
04/19/2013 AMBIEN CR
NDA #021774		 SUPPL-15 ZOLPIDEM TARTRATE COSETTE Labeling Approval
04/19/2013 RECLAST
NDA #021817		 SUPPL-15 ZOLEDRONIC ACID SANDOZ Labeling Approval
04/19/2013 ACTONEL WITH CALCIUM (COPACKAGED)
NDA #021823		 SUPPL-9 CALCIUM CARBONATE; RISEDRONATE SODIUM WARNER CHILCOTT Labeling Approval
04/19/2013 BONIVA
NDA #021858		 SUPPL-8 IBANDRONATE SODIUM ROCHE Labeling Approval
04/19/2013 BONIVA
NDA #021858		 SUPPL-13 IBANDRONATE SODIUM ROCHE Labeling Approval
04/19/2013 BONIVA
NDA #021858		 SUPPL-14 IBANDRONATE SODIUM ROCHE Labeling Approval
04/19/2013 AMITIZA
NDA #021908		 SUPPL-11 LUBIPROSTONE SUCAMPO PHARMA LLC Efficacy Approval
04/19/2013 PRISTIQ
NDA #021992		 SUPPL-35 DESVENLAFAXINE SUCCINATE PF PRISM CV Manufacturing (CMC) Approval
04/19/2013 EDLUAR
NDA #021997		 SUPPL-5 ZOLPIDEM TARTRATE VIATRIS Labeling Approval
04/19/2013 TRELSTAR
NDA #022437		 SUPPL-6 TRIPTORELIN PAMOATE VERITY Manufacturing (CMC) Approval
04/19/2013 OFIRMEV
NDA #022450		 SUPPL-4 ACETAMINOPHEN MALLINCKRODT HOSP Manufacturing (CMC) Approval
04/19/2013 DIFFERIN
NDA #022502		 SUPPL-3 ADAPALENE GALDERMA LABS LP Labeling Approval
04/19/2013 ATELVIA
NDA #022560		 SUPPL-5 RISEDRONATE SODIUM APIL Labeling Approval
04/19/2013 BACTOCILL IN PLASTIC CONTAINER
NDA #050640		 SUPPL-14 OXACILLIN SODIUM BAXTER HLTHCARE Manufacturing (CMC) Approval
04/19/2013 MIRTAZAPINE
ANDA #077376		 SUPPL-11 MIRTAZAPINE AUROBINDO PHARMA Labeling Approval
04/19/2013 MIRTAZAPINE
ANDA #077376		 SUPPL-12 MIRTAZAPINE AUROBINDO PHARMA Labeling Approval
04/19/2013 FENTANYL-100
ANDA #077449		 SUPPL-5 FENTANYL DIFGEN PHARMS REMS Approval
04/19/2013 FENTANYL-12
ANDA #077449		 SUPPL-5 FENTANYL DIFGEN PHARMS REMS Approval
04/19/2013 FENTANYL-25
ANDA #077449		 SUPPL-5 FENTANYL DIFGEN PHARMS REMS Approval
04/19/2013 FENTANYL-37
ANDA #077449		 SUPPL-5 FENTANYL DIFGEN PHARMS REMS Approval
04/19/2013 FENTANYL-50
ANDA #077449		 SUPPL-5 FENTANYL DIFGEN PHARMS REMS Approval
04/19/2013 FENTANYL-62
ANDA #077449		 SUPPL-5 FENTANYL DIFGEN PHARMS REMS Approval
04/19/2013 FENTANYL-75
ANDA #077449		 SUPPL-5 FENTANYL DIFGEN PHARMS REMS Approval
04/19/2013 FENTANYL-87
ANDA #077449		 SUPPL-5 FENTANYL DIFGEN PHARMS REMS Approval
04/19/2013 OMEPRAZOLE AND SODIUM BICARBONATE
ANDA #079182		 ORIG-1 OMEPRAZOLE; SODIUM BICARBONATE STRIDES PHARMA INTL Approval
04/19/2013 METOCLOPRAMIDE HYDROCHLORIDE
ANDA #091392		 ORIG-1 METOCLOPRAMIDE HYDROCHLORIDE FRESENIUS KABI USA Approval
04/19/2013 REBIF
BLA #103780		 SUPPL-5140 INTERFERON BETA-1A SERONO INC Approval
04/19/2013 VASCEPA
NDA #202057		 SUPPL-4 ICOSAPENT ETHYL AMARIN PHARMS Manufacturing (CMC) Approval
04/19/2013 COMPLERA
NDA #202123		 SUPPL-8 EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE GILEAD SCIENCES INC Manufacturing (CMC) Approval
04/19/2013 BINOSTO
NDA #202344		 SUPPL-1 ALENDRONATE SODIUM RADIUS Labeling Approval
04/19/2013 KYPROLIS
NDA #202714		 SUPPL-2 CARFILZOMIB ONYX PHARMS AMGEN Manufacturing (CMC) Approval
04/19/2013 VALSARTAN AND HYDROCHLOROTHIAZIDE
ANDA #203145		 ORIG-1 HYDROCHLOROTHIAZIDE; VALSARTAN MACLEODS PHARMS LTD Approval
04/19/2013 SIMBRINZA
NDA #204251		 ORIG-1 BRIMONIDINE TARTRATE; BRINZOLAMIDE ALCON LABS INC Type 4 - New Combination Approval
04/19/2013 TAYTULLA
NDA #204426		 ORIG-1 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE APIL Type 3 - New Dosage Form Approval
04/21/2013 NAROPIN
NDA #020533		 SUPPL-24 ROPIVACAINE HYDROCHLORIDE FRESENIUS KABI USA Manufacturing (CMC) Approval
04/22/2013 COGENTIN
NDA #012015		 SUPPL-26 BENZTROPINE MESYLATE EPIC PHARMA LLC Labeling Approval
04/22/2013 COGENTIN
NDA #012015		 SUPPL-27 BENZTROPINE MESYLATE EPIC PHARMA LLC Labeling Approval
04/22/2013 CARDIOGEN-82
NDA #019414		 SUPPL-15 RUBIDIUM CHLORIDE RB-82 BRACCO Manufacturing (CMC) Approval
04/22/2013 ACTIQ
NDA #020747		 SUPPL-39 FENTANYL CITRATE CEPHALON Manufacturing (CMC) Approval
04/22/2013 WELCHOL
NDA #021176		 SUPPL-35 COLESEVELAM HYDROCHLORIDE COSETTE Manufacturing (CMC) Approval
04/22/2013 CIPROFLOXACIN HYDROCHLORIDE
ANDA #076639		 SUPPL-10 CIPROFLOXACIN HYDROCHLORIDE UNIQUE Labeling Approval
04/22/2013 OLANZAPINE AND FLUOXETINE HYDROCHLORIDE
ANDA #077528		 SUPPL-2 FLUOXETINE HYDROCHLORIDE; OLANZAPINE TEVA PHARMS Labeling Approval
04/22/2013 DONEPEZIL HYDROCHLORIDE
ANDA #090175		 SUPPL-1 DONEPEZIL HYDROCHLORIDE ZYDUS PHARMS USA INC Labeling Approval
04/22/2013 DONEPEZIL HYDROCHLORIDE
ANDA #090521		 SUPPL-1 DONEPEZIL HYDROCHLORIDE NATCO PHARMA Labeling Approval
04/22/2013 QUININE SULFATE
ANDA #091661		 SUPPL-1 QUININE SULFATE TEVA PHARMS Labeling Approval
04/22/2013 CHLOROTHIAZIDE SODIUM
ANDA #202561		 ORIG-1 CHLOROTHIAZIDE SODIUM AM REGENT Approval
04/22/2013 ROPINIROLE HYDROCHLORIDE
ANDA #202786		 ORIG-1 ROPINIROLE HYDROCHLORIDE ALEMBIC Approval
04/23/2013 NATRECOR
NDA #020920		 SUPPL-33 NESIRITIDE SCIOS LLC Labeling Approval
04/23/2013 OLUX E
NDA #022013		 SUPPL-9 CLOBETASOL PROPIONATE PHARMOBEDIENT Labeling Approval
04/23/2013 PHENTERMINE HYDROCHLORIDE
ANDA #040526		 SUPPL-11 PHENTERMINE HYDROCHLORIDE SUN PHARM INDUSTRIES Manufacturing (CMC) Approval
04/23/2013 CITALOPRAM HYDROBROMIDE
ANDA #077048		 SUPPL-19 CITALOPRAM HYDROBROMIDE COSETTE PHARMS NC Labeling Approval
04/23/2013 HYDROCODONE
ANDA #077723		 SUPPL-9 HYDROCODONE BITARTRATE; IBUPROFEN STRIDES PHARMA Labeling Approval
04/23/2013 HYDROCODONE BITARTRATE AND IBUPROFEN
ANDA #077723		 SUPPL-9 HYDROCODONE BITARTRATE; IBUPROFEN STRIDES PHARMA Labeling Approval
04/23/2013 FAMCICLOVIR
ANDA #090128		 SUPPL-2 FAMCICLOVIR HIKMA Labeling Approval
04/23/2013 IBUPROFEN
ANDA #091237		 SUPPL-1 IBUPROFEN MARKSANS PHARMA Labeling Approval
04/23/2013 IBUPROFEN
ANDA #091355		 SUPPL-1 IBUPROFEN STRIDES PHARMA Labeling Approval
04/23/2013 FLUVOXAMINE MALEATE
ANDA #091482		 ORIG-1 FLUVOXAMINE MALEATE ACTAVIS ELIZABETH Approval
04/23/2013 SIMPONI
BLA #125289		 SUPPL-84 GOLIMUMAB CENTOCOR ORTHO BIOTECH INC Approval
04/23/2013 QUININE SULFATE
ANDA #202581		 SUPPL-1 QUININE SULFATE AUROBINDO PHARMA USA Labeling Approval
04/23/2013 SUMATRIPTAN SUCCINATE
ANDA #202758		 ORIG-1 SUMATRIPTAN SUCCINATE EUGIA PHARMA Approval
04/24/2013 COLYTE
NDA #018983		 SUPPL-45 POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS STRIDES PHARMA INTL Manufacturing (CMC) Approval
04/24/2013 COLYTE WITH FLAVOR PACKS
NDA #018983		 SUPPL-45 POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS STRIDES PHARMA INTL Manufacturing (CMC) Approval
04/24/2013 COLYTE-FLAVORED
NDA #018983		 SUPPL-45 POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS STRIDES PHARMA INTL Manufacturing (CMC) Approval
04/24/2013 FAMVIR
NDA #020363		 SUPPL-42 FAMCICLOVIR NOVARTIS Labeling Approval
04/24/2013 ESTRADIOL
NDA #020538		 SUPPL-31 ESTRADIOL SANDOZ Manufacturing (CMC) Approval
04/24/2013 VIVELLE-DOT
NDA #020538		 SUPPL-31 ESTRADIOL SANDOZ Manufacturing (CMC) Approval
04/24/2013 CUTIVATE
NDA #021152		 SUPPL-6 FLUTICASONE PROPIONATE FOUGERA PHARMS Manufacturing (CMC) Approval
04/24/2013 PREZISTA
NDA #021976		 SUPPL-27 DARUNAVIR JANSSEN PRODS Efficacy Approval
04/24/2013 ZOLINZA
NDA #021991		 SUPPL-6 VORINOSTAT MSD SUB MERCK Labeling Approval
04/24/2013 CIPROFLOXACIN
ANDA #076089		 SUPPL-42 CIPROFLOXACIN IVAX SUB TEVA PHARMS Labeling Approval
04/24/2013 CIPROFLOXACIN HYDROCHLORIDE
ANDA #076089		 SUPPL-42 CIPROFLOXACIN HYDROCHLORIDE IVAX SUB TEVA PHARMS Labeling Approval
04/24/2013 CIPROFLOXACIN HYDROCHLORIDE
ANDA #077859		 SUPPL-17 CIPROFLOXACIN HYDROCHLORIDE AUROBINDO PHARMA Labeling Approval
04/24/2013 CYCLOBENZAPRINE HYDROCHLORIDE
ANDA #090738		 ORIG-1 CYCLOBENZAPRINE HYDROCHLORIDE MYLAN PHARMS INC Tentative Approval
04/24/2013 HUMIRA
BLA #125057		 SUPPL-322 ADALIMUMAB ABBVIE INC Approval
04/24/2013 MORPHINE SULFATE
ANDA #200812		 SUPPL-2 MORPHINE SULFATE STRIDES PHARMA INTL Labeling Approval
04/24/2013 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE
ANDA #200894		 ORIG-1 CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE AMNEAL PHARMS Approval
04/24/2013 PIRMELLA 7/7/7
ANDA #201510		 ORIG-1 ETHINYL ESTRADIOL; NORETHINDRONE LUPIN LTD Approval
04/24/2013 PIRMELLA 1/35
ANDA #201512		 ORIG-1 ETHINYL ESTRADIOL; NORETHINDRONE LUPIN LTD Approval
04/24/2013 PREZISTA
NDA #202895		 SUPPL-4 DARUNAVIR JANSSEN PRODS Efficacy Approval
04/25/2013 HEPATOLITE
NDA #018467		 SUPPL-25 TECHNETIUM TC-99M DISOFENIN KIT SUN PHARM INDS INC Manufacturing (CMC) Approval
04/25/2013 TRELSTAR
NDA #020715		 SUPPL-27 TRIPTORELIN PAMOATE VERITY Manufacturing (CMC) Approval
04/25/2013 TRELSTAR
NDA #021288		 SUPPL-24 TRIPTORELIN PAMOATE VERITY Manufacturing (CMC) Approval
04/25/2013 TACLONEX
NDA #021852		 SUPPL-13 BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE LEO PHARMA AS Manufacturing (CMC) Approval
04/25/2013 TRELSTAR
NDA #022437		 SUPPL-4 TRIPTORELIN PAMOATE VERITY Manufacturing (CMC) Approval
04/25/2013 JALYN
NDA #022460		 SUPPL-3 DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE WAYLIS THERAP Labeling Approval
04/25/2013 JALYN
NDA #022460		 SUPPL-4 DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE WAYLIS THERAP Labeling Approval
04/25/2013 JALYN
NDA #022460		 SUPPL-5 DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE WAYLIS THERAP Labeling Approval
04/25/2013 PRADAXA
NDA #022512		 SUPPL-17 DABIGATRAN ETEXILATE MESYLATE BOEHRINGER INGELHEIM Labeling Approval
04/25/2013 CEFADROXIL
ANDA #065349		 ORIG-1 CEFADROXIL/CEFADROXIL HEMIHYDRATE AUROBINDO Approval
04/25/2013 FINASTERIDE
ANDA #076511		 SUPPL-16 FINASTERIDE TEVA Labeling Approval
04/25/2013 CIPROFLOXACIN HYDROCHLORIDE
ANDA #076794		 SUPPL-29 CIPROFLOXACIN HYDROCHLORIDE WATSON LABS Labeling Approval
04/25/2013 CIPROFLOXACIN HYDROCHLORIDE
ANDA #076896		 SUPPL-15 CIPROFLOXACIN HYDROCHLORIDE CHARTWELL Labeling Approval
04/25/2013 JEVTANA KIT
NDA #201023		 SUPPL-7 CABAZITAXEL SANOFI AVENTIS US Labeling Approval
04/25/2013 INCIVEK
NDA #201917		 SUPPL-8 TELAPREVIR VERTEX PHARMS Labeling Approval
04/25/2013 OXYMORPHONE HYDROCHLORIDE
ANDA #202321		 ORIG-1 OXYMORPHONE HYDROCHLORIDE SPECGX LLC Approval
04/25/2013 NIFEDIPINE
ANDA #202644		 ORIG-1 NIFEDIPINE HERITAGE PHARMA Approval
04/26/2013 LACTATED RINGER'S AND DEXTROSE 5% IN PLASTIC CONTAINER
NDA #016679		 SUPPL-107 CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Manufacturing (CMC) Approval
04/26/2013 LACTATED RINGER'S IN PLASTIC CONTAINER
NDA #016682		 SUPPL-109 CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Manufacturing (CMC) Approval
04/26/2013 SODIUM LACTATE 0.167 MOLAR IN PLASTIC CONTAINER
NDA #016692		 SUPPL-98 SODIUM LACTATE BAXTER HLTHCARE Manufacturing (CMC) Approval
04/26/2013 DEXTROSE 5% AND ELECTROLYTE NO. 48 IN PLASTIC CONTAINER
NDA #017484		 SUPPL-69 DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Manufacturing (CMC) Approval
04/26/2013 DIANEAL 137 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-116 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE VANTIVE US HLTHCARE Manufacturing (CMC) Approval
04/26/2013 DIANEAL 137 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-116 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE VANTIVE US HLTHCARE Manufacturing (CMC) Approval
04/26/2013 DIANEAL 137 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-116 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE VANTIVE US HLTHCARE Manufacturing (CMC) Approval
04/26/2013 DIANEAL LOW CALCIUM W/DEXTROSE 1.5% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-116 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE VANTIVE US HLTHCARE Manufacturing (CMC) Approval
04/26/2013 DIANEAL LOW CALCIUM W/DEXTROSE 2.5% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-116 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE VANTIVE US HLTHCARE Manufacturing (CMC) Approval
04/26/2013 DIANEAL LOW CALCIUM W/DEXTROSE 3.5% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-116 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE VANTIVE US HLTHCARE Manufacturing (CMC) Approval
04/26/2013 DIANEAL LOW CALCIUM W/DEXTROSE 4.25% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-116 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE VANTIVE US HLTHCARE Manufacturing (CMC) Approval
04/26/2013 DIANEAL PD-1 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-116 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE VANTIVE US HLTHCARE Manufacturing (CMC) Approval
04/26/2013 DIANEAL PD-1 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-116 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE VANTIVE US HLTHCARE Manufacturing (CMC) Approval
04/26/2013 DIANEAL PD-1 W/ DEXTROSE 3.5% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-116 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE VANTIVE US HLTHCARE Manufacturing (CMC) Approval
04/26/2013 DIANEAL PD-1 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-116 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE VANTIVE US HLTHCARE Manufacturing (CMC) Approval
04/26/2013 DIANEAL PD-2 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-116 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE VANTIVE US HLTHCARE Manufacturing (CMC) Approval
04/26/2013 DIANEAL PD-2 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-116 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE VANTIVE US HLTHCARE Manufacturing (CMC) Approval
04/26/2013 DIANEAL PD-2 W/ DEXTROSE 3.5% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-116 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE VANTIVE US HLTHCARE Manufacturing (CMC) Approval
04/26/2013 DIANEAL PD-2 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-116 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE VANTIVE US HLTHCARE Manufacturing (CMC) Approval
04/26/2013 LACTATED RINGER'S IN PLASTIC CONTAINER
NDA #018494		 SUPPL-25 CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Manufacturing (CMC) Approval
04/26/2013 POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
NDA #019367		 SUPPL-29 CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Manufacturing (CMC) Approval
04/26/2013 POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
NDA #019367		 SUPPL-29 CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Manufacturing (CMC) Approval
04/26/2013 POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
NDA #019367		 SUPPL-29 CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Manufacturing (CMC) Approval
04/26/2013 POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
NDA #019367		 SUPPL-29 CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Manufacturing (CMC) Approval
04/26/2013 POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
NDA #019367		 SUPPL-29 CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Manufacturing (CMC) Approval
04/26/2013 POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
NDA #019367		 SUPPL-29 CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Manufacturing (CMC) Approval
04/26/2013 DIANEAL PD-2 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER
NDA #020163		 SUPPL-23 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE VANTIVE US HLTHCARE Manufacturing (CMC) Approval
04/26/2013 DIANEAL PD-2 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER
NDA #020163		 SUPPL-23 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE VANTIVE US HLTHCARE Manufacturing (CMC) Approval
04/26/2013 DIANEAL PD-2 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
NDA #020163		 SUPPL-23 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE VANTIVE US HLTHCARE Manufacturing (CMC) Approval
04/26/2013 DIANEAL LOW CALCIUM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER
NDA #020183		 SUPPL-22 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE VANTIVE US HLTHCARE Manufacturing (CMC) Approval
04/26/2013 DIANEAL LOW CALCIUM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER
NDA #020183		 SUPPL-22 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE VANTIVE US HLTHCARE Manufacturing (CMC) Approval
04/26/2013 DIANEAL LOW CALCIUM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER
NDA #020183		 SUPPL-22 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE VANTIVE US HLTHCARE Manufacturing (CMC) Approval
04/26/2013 DIANEAL LOW CALCIUM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
NDA #020183		 SUPPL-22 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE VANTIVE US HLTHCARE Manufacturing (CMC) Approval
04/26/2013 SALAGEN
NDA #020237		 SUPPL-20 PILOCARPINE HYDROCHLORIDE ADVANZ PHARMA Manufacturing (CMC) Approval
04/26/2013 CLARITIN-D 24 HOUR
NDA #020470		 SUPPL-41 LORATADINE; PSEUDOEPHEDRINE SULFATE BAYER HEALTHCARE LLC Manufacturing (CMC) Approval
04/26/2013 ATACAND
NDA #020838		 SUPPL-38 CANDESARTAN CILEXETIL ANI PHARMS Labeling Approval
04/26/2013 GLUCAGEN
NDA #020918		 SUPPL-39 GLUCAGON HYDROCHLORIDE NOVO NORDISK Manufacturing (CMC) Approval
04/26/2013 GLUCAGEN
NDA #020918		 SUPPL-40 GLUCAGON HYDROCHLORIDE NOVO NORDISK Labeling Approval
04/26/2013 ATACAND HCT
NDA #021093		 SUPPL-18 CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE ANI PHARMS Labeling Approval
04/26/2013 EXTRANEAL
NDA #021321		 SUPPL-26 ICODEXTRIN VANTIVE US HLTHCARE Manufacturing (CMC) Approval
04/26/2013 VYVANSE
NDA #021977		 SUPPL-27 LISDEXAMFETAMINE DIMESYLATE TAKEDA PHARMS USA Efficacy Approval
04/26/2013 TOTECT
NDA #022025		 SUPPL-13 DEXRAZOXANE HYDROCHLORIDE CLINIGEN Labeling Approval
04/26/2013 HYDRALAZINE HYDROCHLORIDE
ANDA #040136		 SUPPL-5 HYDRALAZINE HYDROCHLORIDE AM REGENT Labeling Approval
04/26/2013 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #040736		 SUPPL-8 ACETAMINOPHEN; HYDROCODONE BITARTRATE AMNEAL PHARMS NY Manufacturing (CMC) Approval
04/26/2013 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #040746		 SUPPL-8 ACETAMINOPHEN; HYDROCODONE BITARTRATE AMNEAL PHARMS NY Manufacturing (CMC) Approval
04/26/2013 AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #065096		 SUPPL-23 AMOXICILLIN; CLAVULANATE POTASSIUM TEVA PHARMS USA Labeling Approval
04/26/2013 AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #065101		 SUPPL-22 AMOXICILLIN; CLAVULANATE POTASSIUM TEVA Labeling Approval
04/26/2013 AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #065162		 SUPPL-23 AMOXICILLIN; CLAVULANATE POTASSIUM TEVA Labeling Approval
04/26/2013 VANCOMYCIN HYDROCHLORIDE
ANDA #065401		 SUPPL-4 VANCOMYCIN HYDROCHLORIDE EUROFARMA Labeling Approval
04/26/2013 DOXAZOSIN MESYLATE
ANDA #075536		 SUPPL-10 DOXAZOSIN MESYLATE TEVA Labeling Approval
04/26/2013 CITALOPRAM HYDROBROMIDE
ANDA #077534		 SUPPL-6 CITALOPRAM HYDROBROMIDE INVAGEN PHARMS Labeling Approval
04/26/2013 ONDANSETRON
ANDA #077557		 SUPPL-6 ONDANSETRON SUN PHARM INDS Labeling Approval
04/26/2013 OXCARBAZEPINE
ANDA #077747		 SUPPL-6 OXCARBAZEPINE RUBICON RESEARCH Labeling Approval
04/26/2013 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
ANDA #077948		 SUPPL-5 HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM CHARTWELL RX Labeling Approval
04/26/2013 HYDRALAZINE HYDROCHLORIDE
ANDA #088467		 SUPPL-42 HYDRALAZINE HYDROCHLORIDE PLIVA Labeling Approval
04/26/2013 FINASTERIDE
ANDA #090061		 SUPPL-6 FINASTERIDE HETERO LABS LTD III Labeling Approval
04/26/2013 FINASTERIDE
ANDA #090121		 SUPPL-6 FINASTERIDE ACCORD HLTHCARE Labeling Approval
04/26/2013 LEVALBUTEROL HYDROCHLORIDE
ANDA #090297		 ORIG-1 LEVALBUTEROL HYDROCHLORIDE TEVA PHARMS USA Approval
04/26/2013 BUPROPION HYDROCHLORIDE
ANDA #090942		 SUPPL-8 BUPROPION HYDROCHLORIDE AUROBINDO PHARMA USA Labeling Approval
04/26/2013 OXACILLIN SODIUM
ANDA #201538		 SUPPL-1 OXACILLIN SODIUM EUGIA PHARMA SPECLTS Labeling Approval
04/26/2013 OXACILLIN SODIUM
ANDA #201539		 SUPPL-1 OXACILLIN SODIUM EUGIA PHARMA SPECLTS Labeling Approval
04/26/2013 EDURANT
NDA #202022		 SUPPL-4 RILPIVIRINE HYDROCHLORIDE JANSSEN PRODS Manufacturing (CMC) Approval
04/28/2013 CHILDREN'S ALLEGRA ALLERGY
NDA #021909		 SUPPL-7 FEXOFENADINE HYDROCHLORIDE CHATTEM SANOFI Labeling Approval
04/28/2013 CHILDREN'S ALLEGRA HIVES
NDA #021909		 SUPPL-7 FEXOFENADINE HYDROCHLORIDE CHATTEM SANOFI Labeling Approval
04/28/2013 CHILDREN'S ALLEGRA ALLERGY
NDA #201373		 SUPPL-5 FEXOFENADINE HYDROCHLORIDE CHATTEM SANOFI Labeling Approval
04/28/2013 CHILDREN'S ALLEGRA HIVES
NDA #201373		 SUPPL-5 FEXOFENADINE HYDROCHLORIDE CHATTEM SANOFI Labeling Approval
04/29/2013 ZEMURON
NDA #020214		 SUPPL-35 ROCURONIUM BROMIDE ORGANON USA INC Manufacturing (CMC) Approval
04/29/2013 RHINOCORT
NDA #020746		 SUPPL-31 BUDESONIDE KENVUE BRANDS Manufacturing (CMC) Approval
04/29/2013 RHINOCORT ALLERGY
NDA #020746		 SUPPL-31 BUDESONIDE KENVUE BRANDS Manufacturing (CMC) Approval
04/29/2013 COARTEM
NDA #022268		 SUPPL-4 ARTEMETHER; LUMEFANTRINE NOVARTIS Labeling Approval
04/29/2013 NEXTERONE
NDA #022325		 SUPPL-8 AMIODARONE HYDROCHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
04/29/2013 LEUCOVORIN CALCIUM
ANDA #040174		 SUPPL-18 LEUCOVORIN CALCIUM TEVA PHARMS USA Labeling Approval
04/29/2013 VIBRAMYCIN
NDA #050006		 SUPPL-84 DOXYCYCLINE PFIZER Labeling Approval
04/29/2013 VIBRAMYCIN
NDA #050007		 SUPPL-25 DOXYCYCLINE HYCLATE PFIZER Labeling Approval
04/29/2013 VIBRAMYCIN
NDA #050480		 SUPPL-50 DOXYCYCLINE CALCIUM PFIZER Labeling Approval
04/29/2013 VIBRA-TABS
NDA #050533		 SUPPL-40 DOXYCYCLINE HYCLATE PFIZER Labeling Approval
04/29/2013 FORTAZ IN PLASTIC CONTAINER
NDA #050634		 SUPPL-26 CEFTAZIDIME SODIUM PAI HOLDINGS PHARM Manufacturing (CMC) Approval
04/29/2013 ZINACEF IN PLASTIC CONTAINER
NDA #050643		 SUPPL-25 CEFUROXIME SODIUM PAI HOLDINGS PHARM Manufacturing (CMC) Approval
04/29/2013 SULFAMETHOXAZOLE AND TRIMETHOPRIM
ANDA #073303		 SUPPL-23 SULFAMETHOXAZOLE; TRIMETHOPRIM TEVA PHARMS USA Labeling Approval
04/29/2013 SULFAMETHOXAZOLE AND TRIMETHOPRIM
ANDA #073303		 SUPPL-30 SULFAMETHOXAZOLE; TRIMETHOPRIM TEVA PHARMS USA Labeling Approval
04/29/2013 LOVASTATIN
ANDA #075991		 SUPPL-16 LOVASTATIN CARLSBAD Labeling Approval
04/29/2013 OXYBUTYNIN CHLORIDE
ANDA #076644		 SUPPL-12 OXYBUTYNIN CHLORIDE PHARMOBEDIENT Labeling Approval
04/29/2013 OXYBUTYNIN CHLORIDE
ANDA #076702		 SUPPL-10 OXYBUTYNIN CHLORIDE PHARMOBEDIENT Labeling Approval
04/29/2013 IRINOTECAN HYDROCHLORIDE
ANDA #077219		 SUPPL-4 IRINOTECAN HYDROCHLORIDE CIPLA LTD Labeling Approval
04/29/2013 DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
ANDA #077488		 ORIG-1 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TEVA Approval
04/29/2013 FINASTERIDE
ANDA #077914		 SUPPL-8 FINASTERIDE ACTAVIS TOTOWA TEVA Labeling Approval
04/29/2013 METOPROLOL TARTRATE
ANDA #078950		 ORIG-1 METOPROLOL TARTRATE BAXTER HLTHCARE CORP Approval
04/29/2013 TOPIRAMATE
ANDA #079153		 SUPPL-14 TOPIRAMATE TORRENT PHARMS Labeling Approval
04/29/2013 LEUCOVORIN CALCIUM
ANDA #081277		 SUPPL-20 LEUCOVORIN CALCIUM TEVA PHARMS USA Labeling Approval
04/29/2013 IRINOTECAN HYDROCHLORIDE
ANDA #090101		 SUPPL-17 IRINOTECAN HYDROCHLORIDE TEVA PHARMS USA Labeling Approval
04/29/2013 IRINOTECAN HYDROCHLORIDE
ANDA #090101		 SUPPL-18 IRINOTECAN HYDROCHLORIDE TEVA PHARMS USA Labeling Approval
04/29/2013 IRINOTECAN HYDROCHLORIDE
ANDA #090675		 SUPPL-1 IRINOTECAN HYDROCHLORIDE HENGRUI PHARMA Labeling Approval
04/29/2013 HEPARIN SODIUM
ANDA #090808		 SUPPL-5 HEPARIN SODIUM SAGENT PHARMS Labeling Approval
04/29/2013 HEPARIN SODIUM
ANDA #090808		 SUPPL-8 HEPARIN SODIUM SAGENT PHARMS Labeling Approval
04/29/2013 HEPARIN SODIUM
ANDA #090809		 SUPPL-3 HEPARIN SODIUM SAGENT PHARMS Labeling Approval
04/29/2013 HEPARIN SODIUM
ANDA #090809		 SUPPL-4 HEPARIN SODIUM SAGENT PHARMS Labeling Approval
04/29/2013 HEPARIN SODIUM PRESERVATIVE FREE
ANDA #090810		 SUPPL-4 HEPARIN SODIUM SAGENT PHARMS Labeling Approval
04/29/2013 STELARA
BLA #125261		 SUPPL-99 USTEKINUMAB CENTOCOR ORTHO BIOTECH INC Approval
04/29/2013 ACTEMRA
BLA #125276		 SUPPL-64 TOCILIZUMAB GENENTECH Approval
04/29/2013 AMLODIPINE BESYLATE
ANDA #202553		 ORIG-1 AMLODIPINE BESYLATE ACCORD HLTHCARE Approval
04/29/2013 OFLOXACIN
ANDA #202692		 ORIG-1 OFLOXACIN ALTAIRE PHARMS INC Approval
04/29/2013 MONTELUKAST SODIUM
ANDA #202717		 SUPPL-2 MONTELUKAST SODIUM ACCORD HLTHCARE Labeling Approval
04/29/2013 QUINAPRIL HYDROCHLORIDE
ANDA #202725		 ORIG-1 QUINAPRIL HYDROCHLORIDE AUROBINDO PHARMA LTD Approval
04/30/2013 TRANSDERM SCOP
NDA #017874		 SUPPL-38 SCOPOLAMINE BAXTER HLTHCARE CORP Labeling Approval
04/30/2013 SEROQUEL
NDA #020639		 SUPPL-53 QUETIAPINE FUMARATE CHEPLAPHARM Labeling Approval
04/30/2013 SEROQUEL
NDA #020639		 SUPPL-57 QUETIAPINE FUMARATE CHEPLAPHARM Efficacy Approval
04/30/2013 SEROQUEL
NDA #020639		 SUPPL-58 QUETIAPINE FUMARATE CHEPLAPHARM Labeling Approval
04/30/2013 SEROQUEL
NDA #020639		 SUPPL-59 QUETIAPINE FUMARATE CHEPLAPHARM Labeling Approval
04/30/2013 TASMAR
NDA #020697		 SUPPL-19 TOLCAPONE BAUSCH Manufacturing (CMC) Approval
04/30/2013 AVODART
NDA #021319		 SUPPL-28 DUTASTERIDE WAYLIS THERAP Labeling Approval
04/30/2013 AVODART
NDA #021319		 SUPPL-29 DUTASTERIDE WAYLIS THERAP Labeling Approval
04/30/2013 PLAN B ONE-STEP
NDA #021998		 SUPPL-2 LEVONORGESTREL FDN CONSUMER Efficacy Approval
04/30/2013 SEROQUEL XR
NDA #022047		 SUPPL-26 QUETIAPINE FUMARATE CHEPLAPHARM Labeling Approval
04/30/2013 SEROQUEL XR
NDA #022047		 SUPPL-29 QUETIAPINE FUMARATE CHEPLAPHARM Efficacy Approval
04/30/2013 SEROQUEL XR
NDA #022047		 SUPPL-30 QUETIAPINE FUMARATE CHEPLAPHARM Labeling Approval
04/30/2013 SEROQUEL XR
NDA #022047		 SUPPL-31 QUETIAPINE FUMARATE CHEPLAPHARM Labeling Approval
04/30/2013 INTELENCE
NDA #022187		 SUPPL-13 ETRAVIRINE JANSSEN R AND D Manufacturing (CMC) Approval
04/30/2013 TYVASO
NDA #022387		 SUPPL-8 TREPROSTINIL UNITED THERAP Labeling Approval
04/30/2013 DICYCLOMINE HYDROCHLORIDE
ANDA #040230		 SUPPL-15 DICYCLOMINE HYDROCHLORIDE LANNETT Labeling Approval
04/30/2013 DICYCLOMINE HYDROCHLORIDE
ANDA #040317		 SUPPL-11 DICYCLOMINE HYDROCHLORIDE AUROBINDO PHARMA USA Labeling Approval
04/30/2013 DICYCLOMINE HYDROCHLORIDE
ANDA #040319		 SUPPL-8 DICYCLOMINE HYDROCHLORIDE AUROBINDO PHARMA USA Labeling Approval
04/30/2013 HYDROXYZINE HYDROCHLORIDE
ANDA #040580		 SUPPL-5 HYDROXYZINE HYDROCHLORIDE PRINSTON INC Labeling Approval
04/30/2013 CARISOPRODOL
ANDA #040792		 SUPPL-9 CARISOPRODOL AUROBINDO PHARMA Labeling Approval
04/30/2013 CITALOPRAM HYDROBROMIDE
ANDA #077031		 SUPPL-23 CITALOPRAM HYDROBROMIDE AUROBINDO Labeling Approval
04/30/2013 CITALOPRAM HYDROBROMIDE
ANDA #077042		 SUPPL-18 CITALOPRAM HYDROBROMIDE MYLAN Labeling Approval
04/30/2013 CITALOPRAM HYDROBROMIDE
ANDA #077042		 SUPPL-20 CITALOPRAM HYDROBROMIDE MYLAN Labeling Approval
04/30/2013 RIBAVIRIN
ANDA #077053		 SUPPL-13 RIBAVIRIN HERITAGE PHARMA AVET Labeling Approval
04/30/2013 PANTOPRAZOLE SODIUM
ANDA #077058		 SUPPL-10 PANTOPRAZOLE SODIUM SUN PHARM Labeling Approval
04/30/2013 LANSOPRAZOLE
ANDA #077255		 SUPPL-11 LANSOPRAZOLE TEVA PHARMS Labeling Approval
04/30/2013 LANSOPRAZOLE
ANDA #077255		 SUPPL-12 LANSOPRAZOLE TEVA PHARMS Labeling Approval
04/30/2013 BUPROPION HYDROCHLORIDE
ANDA #077285		 SUPPL-19 BUPROPION HYDROCHLORIDE WATSON LABS INC Labeling Approval
04/30/2013 TEMOZOLOMIDE
ANDA #078879		 SUPPL-5 TEMOZOLOMIDE HERITAGE Labeling Approval
04/30/2013 DICYCLOMINE HYDROCHLORIDE
ANDA #084285		 SUPPL-15 DICYCLOMINE HYDROCHLORIDE LANNETT Labeling Approval
04/30/2013 CICLOPIROX
ANDA #090490		 SUPPL-2 CICLOPIROX ACTAVIS MID ATLANTIC Labeling Approval
04/30/2013 TOPOTECAN HYDROCHLORIDE
ANDA #090620		 SUPPL-4 TOPOTECAN HYDROCHLORIDE ACTAVIS TOTOWA Labeling Approval
04/30/2013 DOXYCYCLINE HYCLATE
ANDA #200856		 ORIG-1 DOXYCYCLINE HYCLATE HERITAGE Approval
04/30/2013 CLINDAMYCIN PALMITATE HYDROCHLORIDE
ANDA #202409		 ORIG-1 CLINDAMYCIN PALMITATE HYDROCHLORIDE AUROBINDO PHARMA LTD Approval
04/30/2013 TAMSULOSIN HYDROCHLORIDE
ANDA #202433		 ORIG-1 TAMSULOSIN HYDROCHLORIDE AUROBINDO PHARMA LTD Approval
04/30/2013 PROCYSBI
NDA #203389		 ORIG-1 CYSTEAMINE BITARTRATE HORIZON Type 5 - New Formulation or New Manufacturer Approval
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