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Drugs@FDA: FDA-Approved Drugs

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All Approvals and Tentative Approvals
March 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
03/01/2013 SPORANOX
NDA #020083		 SUPPL-51 ITRACONAZOLE JANSSEN PHARMS Manufacturing (CMC) Approval
03/01/2013 MEPRON
NDA #020500		 SUPPL-14 ATOVAQUONE GLAXOSMITHKLINE LLC Labeling Approval
03/01/2013 MIRAPEX
NDA #020667		 SUPPL-29 PRAMIPEXOLE DIHYDROCHLORIDE BOEHRINGER INGELHEIM Labeling Approval
03/01/2013 GEODON
NDA #020825		 SUPPL-46 ZIPRASIDONE HYDROCHLORIDE VIATRIS Labeling Approval
03/01/2013 GEODON
NDA #020919		 SUPPL-30 ZIPRASIDONE MESYLATE VIATRIS Labeling Approval
03/01/2013 SOMAVERT
BLA #021106		 SUPPL-39 PEGVISOMANT PHARMACIA Approval
03/01/2013 VFEND
NDA #021266		 SUPPL-36 VORICONAZOLE PF PRISM CV Manufacturing (CMC) Approval
03/01/2013 GEODON
NDA #021483		 SUPPL-9 ZIPRASIDONE HYDROCHLORIDE PFIZER INC Labeling Approval
03/01/2013 FEMCON FE
NDA #021490		 SUPPL-12 ETHINYL ESTRADIOL; NORETHINDRONE APIL Manufacturing (CMC) Approval
03/01/2013 VEREGEN
NDA #021902		 SUPPL-26 SINECATECHINS ANI PHARMS Manufacturing (CMC) Approval
03/01/2013 XARELTO
NDA #022406		 SUPPL-4 RIVAROXABAN JANSSEN PHARMS Efficacy Approval
03/01/2013 MIRAPEX ER
NDA #022421		 SUPPL-7 PRAMIPEXOLE DIHYDROCHLORIDE BOEHRINGER INGELHEIM Labeling Approval
03/01/2013 LO LOESTRIN FE
NDA #022501		 SUPPL-4 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE APIL Manufacturing (CMC) Approval
03/01/2013 LISINOPRIL
ANDA #076071		 SUPPL-20 LISINOPRIL STRIDES PHARMA Labeling Approval
03/01/2013 LISINOPRIL
ANDA #076071		 SUPPL-21 LISINOPRIL STRIDES PHARMA Labeling Approval
03/01/2013 LISINOPRIL
ANDA #076071		 SUPPL-23 LISINOPRIL STRIDES PHARMA Labeling Approval
03/01/2013 TRAVOPROST
ANDA #091340		 ORIG-1 TRAVOPROST CHARTWELL RX Approval
03/01/2013 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
ANDA #201682		 ORIG-1 HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM IPCA LABS LTD Approval
03/01/2013 ONFI
NDA #202067		 SUPPL-1 CLOBAZAM LUNDBECK PHARMS LLC Manufacturing (CMC) Approval
03/04/2013 TECHNETIUM TC 99M ALBUMIN AGGREGATED KIT
BLA #017881		 SUPPL-22 TECHNETIUM TC-99M ALBUMIN AGGREGATED KIT DRAXIMAGE Approval
03/04/2013 CARAFATE
NDA #018333		 SUPPL-34 SUCRALFATE ABBVIE Labeling Approval
03/04/2013 CARAFATE
NDA #019183		 SUPPL-16 SUCRALFATE ABBVIE Labeling Approval
03/04/2013 INOMAX
NDA #020845		 SUPPL-14 NITRIC OXIDE MALLINCKRODT IRELAND Labeling Approval
03/04/2013 ZIANA
NDA #050802		 SUPPL-12 CLINDAMYCIN PHOSPHATE; TRETINOIN BAUSCH Manufacturing (CMC) Approval
03/04/2013 ZOLEDRONIC ACID
ANDA #090018		 ORIG-1 ZOLEDRONIC ACID SUN PHARMA GLOBAL Approval
03/04/2013 ZOLEDRONIC ACID
ANDA #091170		 ORIG-1 ZOLEDRONIC ACID BRECKENRIDGE Approval
03/04/2013 ZOLEDRONIC ACID
ANDA #091186		 ORIG-1 ZOLEDRONIC ACID DR REDDYS LABS LTD Approval
03/04/2013 HYDRALAZINE HYDROCHLORIDE
ANDA #091679		 ORIG-1 HYDRALAZINE HYDROCHLORIDE ACTAVIS GRP PTC Approval
03/04/2013 ERBITUX
BLA #125084		 SUPPL-242 CETUXIMAB IMCLONE Approval
03/04/2013 WARFARIN SODIUM
ANDA #202202		 ORIG-1 WARFARIN SODIUM AMNEAL PHARMS Approval
03/04/2013 ZOLEDRONIC ACID
ANDA #202472		 ORIG-1 ZOLEDRONIC ACID ACTAVIS INC Approval
03/04/2013 MYRBETRIQ
NDA #202611		 SUPPL-1 MIRABEGRON APGDI Manufacturing (CMC) Approval
03/04/2013 ZOLEDRONIC ACID
ANDA #202650		 ORIG-1 ZOLEDRONIC ACID MYLAN LABS LTD Approval
03/04/2013 ZOLEDRONIC ACID
ANDA #202746		 ORIG-1 ZOLEDRONIC ACID SUN PHARMA GLOBAL Approval
03/04/2013 DESVENLAFAXINE
NDA #204150		 ORIG-1 DESVENLAFAXINE ALEMBIC PHARMS LTD Type 5 - New Formulation or New Manufacturer Approval
03/05/2013 AGGRASTAT
NDA #020913		 SUPPL-16 TIROFIBAN HYDROCHLORIDE MEDICURE Manufacturing (CMC) Approval
03/05/2013 LEXIVA
NDA #021548		 SUPPL-32 FOSAMPRENAVIR CALCIUM VIIV HLTHCARE Manufacturing (CMC) Approval
03/05/2013 FIRMAGON
NDA #022201		 SUPPL-2 DEGARELIX ACETATE FERRING Labeling Approval
03/05/2013 ORAVIG
NDA #022404		 SUPPL-3 MICONAZOLE GALT PHARMS Labeling Approval
03/05/2013 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
ANDA #078245		 SUPPL-5 HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM LUPIN LTD Labeling Approval
03/05/2013 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
ANDA #078245		 SUPPL-14 HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM LUPIN LTD Labeling Approval
03/06/2013 DILANTIN-125
NDA #008762		 SUPPL-47 PHENYTOIN VIATRIS Labeling Approval
03/06/2013 DILANTIN-30
NDA #008762		 SUPPL-47 PHENYTOIN VIATRIS Labeling Approval
03/06/2013 DILANTIN
NDA #010151		 SUPPL-37 PHENYTOIN SODIUM PARKE DAVIS Labeling Approval
03/06/2013 TEGRETOL
NDA #016608		 SUPPL-105 CARBAMAZEPINE NOVARTIS Labeling Approval
03/06/2013 SILVADENE
NDA #017381		 SUPPL-50 SILVER SULFADIAZINE KING PHARMS LLC Labeling Approval
03/06/2013 TEGRETOL
NDA #018281		 SUPPL-53 CARBAMAZEPINE NOVARTIS Labeling Approval
03/06/2013 TEGRETOL
NDA #018927		 SUPPL-46 CARBAMAZEPINE NOVARTIS Labeling Approval
03/06/2013 LIORESAL
NDA #020075		 SUPPL-26 BACLOFEN AMNEAL Manufacturing (CMC) Approval
03/06/2013 TEGRETOL-XR
NDA #020234		 SUPPL-38 CARBAMAZEPINE NOVARTIS Labeling Approval
03/06/2013 CEREBYX
NDA #020450		 SUPPL-20 FOSPHENYTOIN SODIUM PARKE DAVIS Labeling Approval
03/06/2013 ZOMETA
NDA #021223		 SUPPL-25 ZOLEDRONIC ACID NOVARTIS Manufacturing (CMC) Approval
03/06/2013 CEFTRIAXONE
ANDA #065125		 SUPPL-14 CEFTRIAXONE SODIUM LUPIN Labeling Approval
03/06/2013 CLARITHROMYCIN
ANDA #065384		 SUPPL-6 CLARITHROMYCIN CHARTWELL Labeling Approval
03/06/2013 METHYLERGONOVINE MALEATE
ANDA #090193		 SUPPL-2 METHYLERGONOVINE MALEATE AM REGENT Labeling Approval
03/06/2013 AMYVID
NDA #202008		 SUPPL-12 FLORBETAPIR F-18 AVID RADIOPHARMS INC Manufacturing (CMC) Approval
03/06/2013 AMYVID
NDA #202008		 SUPPL-13 FLORBETAPIR F-18 AVID RADIOPHARMS INC Manufacturing (CMC) Approval
03/06/2013 AMYVID
NDA #202008		 SUPPL-16 FLORBETAPIR F-18 AVID RADIOPHARMS INC Manufacturing (CMC) Approval
03/07/2013 ARTHROTEC
NDA #020607		 SUPPL-25 DICLOFENAC SODIUM; MISOPROSTOL PFIZER Labeling Approval
03/07/2013 RAPAMUNE
NDA #021083		 SUPPL-53 SIROLIMUS PF PRISM CV Labeling Approval
03/07/2013 VISICOL
NDA #021097		 SUPPL-16 SODIUM PHOSPHATE, DIBASIC, ANHYDROUS; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE SALIX PHARMS Labeling Approval
03/07/2013 RAPAMUNE
NDA #021110		 SUPPL-67 SIROLIMUS PF PRISM CV Labeling Approval
03/07/2013 LEXAPRO
NDA #021323		 SUPPL-39 ESCITALOPRAM OXALATE ABBVIE Manufacturing (CMC) Approval
03/07/2013 WELCHOL
NDA #022362		 SUPPL-16 COLESEVELAM HYDROCHLORIDE COSETTE Manufacturing (CMC) Approval
03/07/2013 COLY-MYCIN M
NDA #050108		 SUPPL-30 COLISTIMETHATE SODIUM PH HEALTH Labeling Approval
03/07/2013 AMOXICILLIN
ANDA #065255		 SUPPL-8 AMOXICILLIN HIKMA Labeling Approval
03/07/2013 AMOXICILLIN
ANDA #065322		 SUPPL-13 AMOXICILLIN HIKMA Labeling Approval
03/07/2013 AMOXICILLIN
ANDA #065325		 SUPPL-11 AMOXICILLIN HIKMA Labeling Approval
03/07/2013 FENTANYL-100
ANDA #077449		 SUPPL-4 FENTANYL DIFGEN PHARMS Labeling Approval
03/07/2013 FENTANYL-12
ANDA #077449		 SUPPL-4 FENTANYL DIFGEN PHARMS Labeling Approval
03/07/2013 FENTANYL-25
ANDA #077449		 SUPPL-4 FENTANYL DIFGEN PHARMS Labeling Approval
03/07/2013 FENTANYL-37
ANDA #077449		 SUPPL-4 FENTANYL DIFGEN PHARMS Labeling Approval
03/07/2013 FENTANYL-50
ANDA #077449		 SUPPL-4 FENTANYL DIFGEN PHARMS Labeling Approval
03/07/2013 FENTANYL-62
ANDA #077449		 SUPPL-4 FENTANYL DIFGEN PHARMS Labeling Approval
03/07/2013 FENTANYL-75
ANDA #077449		 SUPPL-4 FENTANYL DIFGEN PHARMS Labeling Approval
03/07/2013 FENTANYL-87
ANDA #077449		 SUPPL-4 FENTANYL DIFGEN PHARMS Labeling Approval
03/07/2013 ENSKYCE
ANDA #201887		 ORIG-1 DESOGESTREL; ETHINYL ESTRADIOL LUPIN LTD Approval
03/08/2013 CERETEC
NDA #019829		 SUPPL-25 TECHNETIUM TC-99M EXAMETAZIME KIT GE HEALTHCARE Manufacturing (CMC) Approval
03/08/2013 MYOVIEW
NDA #020372		 SUPPL-25 TECHNETIUM TC-99M TETROFOSMIN KIT MEDI-PHYSICS Manufacturing (CMC) Approval
03/08/2013 MYOVIEW 30ML
NDA #020372		 SUPPL-25 TECHNETIUM TC-99M TETROFOSMIN KIT MEDI-PHYSICS Manufacturing (CMC) Approval
03/08/2013 COPAXONE
NDA #020622		 SUPPL-87 GLATIRAMER ACETATE TEVA PHARMS USA Manufacturing (CMC) Approval
03/08/2013 SEPTOCAINE
NDA #020971		 SUPPL-28 ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE DEPROCO Manufacturing (CMC) Approval
03/08/2013 ADDERALL XR 10
NDA #021303		 SUPPL-25 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TAKEDA PHARMS USA Labeling Approval
03/08/2013 ADDERALL XR 15
NDA #021303		 SUPPL-25 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TAKEDA PHARMS USA Labeling Approval
03/08/2013 ADDERALL XR 20
NDA #021303		 SUPPL-25 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TAKEDA PHARMS USA Labeling Approval
03/08/2013 ADDERALL XR 25
NDA #021303		 SUPPL-25 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TAKEDA PHARMS USA Labeling Approval
03/08/2013 ADDERALL XR 30
NDA #021303		 SUPPL-25 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TAKEDA PHARMS USA Labeling Approval
03/08/2013 ADDERALL XR 5
NDA #021303		 SUPPL-25 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TAKEDA PHARMS USA Labeling Approval
03/08/2013 BUTRANS
NDA #021306		 SUPPL-13 BUPRENORPHINE KNOA PHARMA Manufacturing (CMC) Approval
03/08/2013 NICORETTE
NDA #021330		 SUPPL-14 NICOTINE POLACRILEX HALEON US HOLDINGS Manufacturing (CMC) Approval
03/08/2013 ZANAFLEX
NDA #021447		 SUPPL-5 TIZANIDINE HYDROCHLORIDE LEGACY Labeling Approval
03/08/2013 NICORETTE
NDA #022360		 SUPPL-5 NICOTINE POLACRILEX HALEON US HOLDINGS Approval
03/08/2013 MERCAPTOPURINE
ANDA #040461		 SUPPL-6 MERCAPTOPURINE DR REDDYS LABS SA Labeling Approval
03/08/2013 CARBOPLATIN
ANDA #078280		 SUPPL-6 CARBOPLATIN SANDOZ Labeling Approval
03/08/2013 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
ANDA #078385		 SUPPL-8 HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM ZYDUS PHARMS USA INC Labeling Approval
03/08/2013 LEVOFLOXACIN
ANDA #078424		 SUPPL-7 LEVOFLOXACIN LUPIN Labeling Approval
03/08/2013 DORZOLAMIDE HYDROCHLORIDE
ANDA #078756		 SUPPL-3 DORZOLAMIDE HYDROCHLORIDE TEVA PHARMS Labeling Approval
03/08/2013 IBANDRONATE SODIUM
ANDA #078997		 SUPPL-1 IBANDRONATE SODIUM DR REDDYS LABS LTD Labeling Approval
03/08/2013 LEVOFLOXACIN
ANDA #091678		 SUPPL-2 LEVOFLOXACIN NOVITIUM PHARMA Labeling Approval
03/08/2013 LUCENTIS
BLA #125156		 SUPPL-87 RANIBIZUMAB GENENTECH Approval
03/08/2013 CABERGOLINE
ANDA #201503		 ORIG-1 CABERGOLINE APOTEX CORP Approval
03/09/2013 HUMULIN R
BLA #018780		 SUPPL-132 INSULIN HUMAN LILLY Approval
03/09/2013 HUMULIN R
BLA #018780		 SUPPL-132 INSULIN RECOMBINANT HUMAN LILLY Approval
03/09/2013 HUMULIN R KWIKPEN
BLA #018780		 SUPPL-132 INSULIN HUMAN LILLY Approval
03/09/2013 HUMULIN R PEN
BLA #018780		 SUPPL-132 INSULIN RECOMBINANT HUMAN LILLY Approval
03/09/2013 HUMULIN N
BLA #018781		 SUPPL-121 INSULIN SUSP ISOPHANE RECOMBINANT HUMAN LILLY Approval
03/09/2013 HUMULIN 70/30
BLA #019717		 SUPPL-99 INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN LILLY Approval
03/09/2013 HUMULIN 70/30 PEN
BLA #019717		 SUPPL-99 INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN LILLY Approval
03/09/2013 NOVOLIN R
BLA #019938		 SUPPL-71 INSULIN RECOMBINANT HUMAN NOVO NORDISK INC Approval
03/09/2013 NOVOLIN N
BLA #019959		 SUPPL-73 INSULIN SUSP ISOPHANE RECOMBINANT HUMAN NOVO NORDISK INC Approval
03/09/2013 NOVOLIN 70/30
BLA #019991		 SUPPL-74 INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN NOVO NORDISK INC Approval
03/09/2013 NOVOLOG
BLA #020986		 SUPPL-67 INSULIN ASPART RECOMBINANT NOVO NORDISK INC Approval
03/09/2013 NOVOLOG FLEXPEN
BLA #020986		 SUPPL-67 INSULIN ASPART RECOMBINANT NOVO NORDISK INC Approval
03/09/2013 NOVOLOG FLEXTOUCH
BLA #020986		 SUPPL-67 INSULIN ASPART RECOMBINANT NOVO NORDISK INC Approval
03/09/2013 NOVOLOG INNOLET
BLA #020986		 SUPPL-67 INSULIN ASPART RECOMBINANT NOVO NORDISK INC Approval
03/09/2013 NOVOLOG PENFILL
BLA #020986		 SUPPL-67 INSULIN ASPART RECOMBINANT NOVO NORDISK INC Approval
03/09/2013 NOVOLOG MIX 70/30
BLA #021172		 SUPPL-53 INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT NOVO NORDISK INC Approval
03/09/2013 NOVOLOG MIX 70/30 FLEXPEN
BLA #021172		 SUPPL-53 INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT NOVO NORDISK INC Approval
03/09/2013 NOVOLOG MIX 70/30 PENFILL
BLA #021172		 SUPPL-53 INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT NOVO NORDISK INC Approval
03/09/2013 LEVEMIR
BLA #021536		 SUPPL-35 INSULIN DETEMIR RECOMBINANT NOVO NORDISK INC Approval
03/09/2013 LEVEMIR FLEXPEN
BLA #021536		 SUPPL-35 INSULIN DETEMIR RECOMBINANT NOVO NORDISK INC Approval
03/09/2013 LEVEMIR FLEXTOUCH
BLA #021536		 SUPPL-35 INSULIN DETEMIR RECOMBINANT NOVO NORDISK INC Approval
03/09/2013 LEVEMIR INNOLET
BLA #021536		 SUPPL-35 INSULIN DETEMIR RECOMBINANT NOVO NORDISK INC Approval
03/09/2013 LEVEMIR PENFILL
BLA #021536		 SUPPL-35 INSULIN DETEMIR RECOMBINANT NOVO NORDISK INC Approval
03/09/2013 NOVOLOG MIX 50/50
BLA #021810		 SUPPL-4 INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT NOVO NORDISK INC Approval
03/11/2013 HUMALOG
BLA #020563		 SUPPL-115 INSULIN LISPRO RECOMBINANT LILLY Approval
03/11/2013 HUMALOG KWIKPEN
BLA #020563		 SUPPL-115 INSULIN LISPRO RECOMBINANT LILLY Approval
03/11/2013 HUMALOG PEN
BLA #020563		 SUPPL-115 INSULIN LISPRO RECOMBINANT LILLY Approval
03/11/2013 HUMALOG TEMPO PEN
BLA #020563		 SUPPL-115 INSULIN LISPRO RECOMBINANT LILLY Approval
03/11/2013 HUMALOG MIX 75/25
BLA #021017		 SUPPL-72 INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT LILLY Approval
03/11/2013 HUMALOG MIX 75/25 KWIKPEN
BLA #021017		 SUPPL-72 INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT LILLY Approval
03/11/2013 HUMALOG MIX 75/25 PEN
BLA #021017		 SUPPL-72 INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT LILLY Approval
03/11/2013 HUMALOG MIX 50/50
BLA #021018		 SUPPL-67 INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT LILLY Approval
03/11/2013 HUMALOG MIX 50/50 KWIKPEN
BLA #021018		 SUPPL-67 INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT LILLY Approval
03/11/2013 HUMALOG MIX 50/50 PEN
BLA #021018		 SUPPL-67 INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT LILLY Approval
03/11/2013 NAMENDA
NDA #021487		 SUPPL-17 MEMANTINE HYDROCHLORIDE ABBVIE Manufacturing (CMC) Approval
03/11/2013 FIBRICOR
NDA #022418		 SUPPL-10 FENOFIBRIC ACID ROSEMONT Labeling Approval
03/11/2013 CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER
NDA #050796		 SUPPL-14 CEFTRIAXONE SODIUM B BRAUN Labeling Approval
03/11/2013 CEFOTAXIME SODIUM
ANDA #065124		 SUPPL-9 CEFOTAXIME SODIUM LUPIN Labeling Approval
03/11/2013 BUPROPION HYDROCHLORIDE
ANDA #077285		 SUPPL-20 BUPROPION HYDROCHLORIDE WATSON LABS INC REMS Approval
03/11/2013 BUPROPION HYDROCHLORIDE
ANDA #077455		 SUPPL-20 BUPROPION HYDROCHLORIDE WATSON LABS INC REMS Approval
03/11/2013 CLINDAMYCIN HYDROCHLORIDE
ANDA #091225		 SUPPL-1 CLINDAMYCIN HYDROCHLORIDE PHARMOBEDIENT Labeling Approval
03/11/2013 IRBESARTAN
ANDA #202254		 SUPPL-2 IRBESARTAN MACLEODS PHARMS LTD Manufacturing (CMC) Approval
03/12/2013 DURACLON
NDA #020615		 SUPPL-5 CLONIDINE HYDROCHLORIDE MYLAN INSTITUTIONAL Manufacturing (CMC) Approval
03/12/2013 TRELSTAR
NDA #020715		 SUPPL-30 TRIPTORELIN PAMOATE VERITY Labeling Approval
03/12/2013 TRELSTAR
NDA #021288		 SUPPL-27 TRIPTORELIN PAMOATE VERITY Labeling Approval
03/12/2013 VIREAD
NDA #021356		 SUPPL-45 TENOFOVIR DISOPROXIL FUMARATE GILEAD SCIENCES INC Manufacturing (CMC) Approval
03/12/2013 ANDROGEL
NDA #022309		 SUPPL-7 TESTOSTERONE BESINS HLTHCARE Labeling Approval
03/12/2013 TRELSTAR
NDA #022437		 SUPPL-7 TRIPTORELIN PAMOATE VERITY Labeling Approval
03/12/2013 AZASITE
NDA #050810		 SUPPL-15 AZITHROMYCIN THEA PHARMA Manufacturing (CMC) Approval
03/12/2013 ONDANSETRON HYDROCHLORIDE
ANDA #077517		 SUPPL-3 ONDANSETRON HYDROCHLORIDE CHARTWELL RX Labeling Approval
03/12/2013 PIOGLITAZONE HYDROCHLORIDE
ANDA #078383		 ORIG-1 PIOGLITAZONE HYDROCHLORIDE CHARTWELL RX Approval
03/12/2013 PIOGLITAZONE HYDROCHLORIDE
ANDA #078383		 SUPPL-1 PIOGLITAZONE HYDROCHLORIDE CHARTWELL RX Approval
03/12/2013 PIOGLITAZONE HYDROCHLORIDE
ANDA #078383		 SUPPL-2 PIOGLITAZONE HYDROCHLORIDE CHARTWELL RX Approval
03/12/2013 IBUPROFEN
ANDA #078682		 SUPPL-3 IBUPROFEN BIONPHARMA Labeling Approval
03/12/2013 QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #091524		 ORIG-1 HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE APOTEX Approval
03/12/2013 ZOLEDRONIC ACID
ANDA #201783		 ORIG-1 ZOLEDRONIC ACID AVET LIFESCIENCES Approval
03/12/2013 XALKORI
NDA #202570		 SUPPL-5 CRIZOTINIB PF PRISM CV Manufacturing (CMC) Approval
03/12/2013 NEVIRAPINE
ANDA #203021		 SUPPL-1 NEVIRAPINE APOTEX INC Labeling Approval
03/13/2013 CELESTONE SOLUSPAN
NDA #014602		 SUPPL-56 BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE ORGANON Manufacturing (CMC) Approval
03/13/2013 DESOWEN
NDA #019048		 SUPPL-15 DESONIDE GALDERMA LABS LP Manufacturing (CMC) Approval
03/13/2013 CLARITIN-D
NDA #019670		 SUPPL-30 LORATADINE; PSEUDOEPHEDRINE SULFATE BAYER HEALTHCARE LLC Manufacturing (CMC) Approval
03/13/2013 XALATAN
NDA #020597		 SUPPL-46 LATANOPROST UPJOHN Manufacturing (CMC) Approval
03/13/2013 PRECEDEX
NDA #021038		 SUPPL-20 DEXMEDETOMIDINE HYDROCHLORIDE HOSPIRA Manufacturing (CMC) Approval
03/13/2013 CETROTIDE
NDA #021197		 SUPPL-14 CETRORELIX ACETATE EMD SERONO INC Manufacturing (CMC) Approval
03/13/2013 MONISTAT 1 COMBINATION PACK
NDA #021308		 SUPPL-20 MICONAZOLE NITRATE MEDTECH PRODUCTS Manufacturing (CMC) Approval
03/13/2013 FORTEO
NDA #021318		 SUPPL-33 TERIPARATIDE LILLY Manufacturing (CMC) Approval
03/13/2013 ALIMTA
NDA #021462		 SUPPL-41 PEMETREXED DISODIUM LILLY Manufacturing (CMC) Approval
03/13/2013 FUZEON
NDA #021481		 SUPPL-26 ENFUVIRTIDE ROCHE Manufacturing (CMC) Approval
03/13/2013 EXELON
NDA #022083		 SUPPL-18 RIVASTIGMINE SANDOZ Manufacturing (CMC) Approval
03/13/2013 ANDROGEL
NDA #022309		 SUPPL-5 TESTOSTERONE BESINS HLTHCARE Manufacturing (CMC) Approval
03/13/2013 LATISSE
NDA #022369		 SUPPL-7 BIMATOPROST ABBVIE Manufacturing (CMC) Approval
03/13/2013 NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
NDA #022573		 SUPPL-3 ETHINYL ESTRADIOL; NORETHINDRONE TEVA BRANDED PHARM Manufacturing (CMC) Approval
03/13/2013 AZELASTINE HYDROCHLORIDE
ANDA #077954		 SUPPL-4 AZELASTINE HYDROCHLORIDE APOTEX INC Labeling Approval
03/13/2013 FLUVOXAMINE MALEATE
ANDA #091476		 ORIG-1 FLUVOXAMINE MALEATE PH HEALTH Approval
03/13/2013 AVONEX
BLA #103628		 SUPPL-5206 INTERFERON BETA-1A BIOGEN Approval
03/13/2013 JEVTANA KIT
NDA #201023		 SUPPL-8 CABAZITAXEL SANOFI AVENTIS US Manufacturing (CMC) Approval
03/13/2013 AMYVID
NDA #202008		 SUPPL-9 FLORBETAPIR F-18 AVID RADIOPHARMS INC Manufacturing (CMC) Approval
03/13/2013 RAYOS
NDA #202020		 SUPPL-1 PREDNISONE HORIZON Manufacturing (CMC) Approval
03/13/2013 LYMPHOSEEK KIT
NDA #202207		 ORIG-1 TECHNETIUM TC-99M TILMANOCEPT CARDINAL HEALTH 414 Type 1 - New Molecular Entity Approval
03/14/2013 LOPRESSOR
NDA #017963		 SUPPL-68 METOPROLOL TARTRATE VALIDUS PHARMS Labeling Approval
03/14/2013 MICRO-K
NDA #018238		 SUPPL-39 POTASSIUM CHLORIDE NESHER PHARMS Manufacturing (CMC) Approval
03/14/2013 MICRO-K 10
NDA #018238		 SUPPL-39 POTASSIUM CHLORIDE NESHER PHARMS Manufacturing (CMC) Approval
03/14/2013 TECHNESCAN HDP
NDA #018321		 SUPPL-20 TECHNETIUM TC-99M OXIDRONATE KIT CURIUM Manufacturing (CMC) Approval
03/14/2013 LOPRESSOR
NDA #018704		 SUPPL-26 METOPROLOL TARTRATE NOVARTIS Labeling Approval
03/14/2013 GLUCOPHAGE
NDA #020357		 SUPPL-35 METFORMIN HYDROCHLORIDE EMD SERONO INC Manufacturing (CMC) Approval
03/14/2013 AMARYL
NDA #020496		 SUPPL-24 GLIMEPIRIDE SANOFI AVENTIS US Manufacturing (CMC) Approval
03/14/2013 HUMALOG
BLA #020563		 SUPPL-135 INSULIN LISPRO RECOMBINANT LILLY Approval
03/14/2013 HUMALOG KWIKPEN
BLA #020563		 SUPPL-135 INSULIN LISPRO RECOMBINANT LILLY Approval
03/14/2013 HUMALOG PEN
BLA #020563		 SUPPL-135 INSULIN LISPRO RECOMBINANT LILLY Approval
03/14/2013 HUMALOG TEMPO PEN
BLA #020563		 SUPPL-135 INSULIN LISPRO RECOMBINANT LILLY Approval
03/14/2013 CREON
BLA #020725		 SUPPL-16 PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) ABBVIE Approval
03/14/2013 CYCLOSET
NDA #020866		 SUPPL-5 BROMOCRIPTINE MESYLATE VEROSCIENCE Manufacturing (CMC) Approval
03/14/2013 GLUCOVANCE
NDA #021178		 SUPPL-13 GLYBURIDE; METFORMIN HYDROCHLORIDE BRISTOL MYERS SQUIBB Manufacturing (CMC) Approval
03/14/2013 XOPENEX HFA
NDA #021730		 SUPPL-32 LEVALBUTEROL TARTRATE LUPIN Manufacturing (CMC) Approval
03/14/2013 OLANZAPINE AND FLUOXETINE HYDROCHLORIDE
ANDA #077742		 SUPPL-2 FLUOXETINE HYDROCHLORIDE; OLANZAPINE PH HEALTH Labeling Approval
03/14/2013 PHENTERMINE HYDROCHLORIDE
ANDA #087022		 SUPPL-15 PHENTERMINE HYDROCHLORIDE LANNETT Manufacturing (CMC) Approval
03/14/2013 ALPRAZOLAM
ANDA #090082		 SUPPL-1 ALPRAZOLAM SUN PHARM Labeling Approval
03/14/2013 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
ANDA #091617		 SUPPL-1 HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM ALEMBIC PHARMS LTD Labeling Approval
03/14/2013 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE
ANDA #203040		 ORIG-1 LIDOCAINE HYDROCHLORIDE EUGIA PHARMA Approval
03/14/2013 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE
ANDA #203082		 ORIG-1 LIDOCAINE HYDROCHLORIDE EUGIA PHARMA Approval
03/15/2013 FREAMINE 8.5%
NDA #016822		 SUPPL-75 AMINO ACIDS B BRAUN Manufacturing (CMC) Approval
03/15/2013 FREAMINE HBC 6.9%
NDA #016822		 SUPPL-75 AMINO ACIDS B BRAUN Manufacturing (CMC) Approval
03/15/2013 FREAMINE II 8.5%
NDA #016822		 SUPPL-75 AMINO ACIDS B BRAUN Manufacturing (CMC) Approval
03/15/2013 FREAMINE III 10%
NDA #016822		 SUPPL-75 AMINO ACIDS B BRAUN Manufacturing (CMC) Approval
03/15/2013 FREAMINE III 3% W/ ELECTROLYTES
NDA #016822		 SUPPL-75 AMINO ACIDS; MAGNESIUM ACETATE; PHOSPHORIC ACID; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
03/15/2013 FREAMINE III 8.5%
NDA #016822		 SUPPL-75 AMINO ACIDS B BRAUN Manufacturing (CMC) Approval
03/15/2013 FREAMINE III 8.5% W/ ELECTROLYTES
NDA #016822		 SUPPL-75 AMINO ACIDS; MAGNESIUM ACETATE; PHOSPHORIC ACID; POTASSIUM ACETATE; POTASSIUM CHLORIDE; SODIUM ACETATE B BRAUN Manufacturing (CMC) Approval
03/15/2013 ULTRA-TECHNEKOW V4
NDA #017243		 SUPPL-39 TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR CURIUM Manufacturing (CMC) Approval
03/15/2013 CETROTIDE
NDA #021197		 SUPPL-13 CETRORELIX ACETATE EMD SERONO INC Manufacturing (CMC) Approval
03/15/2013 OXYTROL
NDA #021351		 SUPPL-11 OXYBUTYNIN ALLERGAN Manufacturing (CMC) Approval
03/15/2013 MAXIPIME
NDA #050679		 SUPPL-34 CEFEPIME HYDROCHLORIDE HOSPIRA INC Labeling Approval
03/15/2013 LEVALBUTEROL HYDROCHLORIDE
ANDA #077800		 ORIG-1 LEVALBUTEROL HYDROCHLORIDE PHARMOBEDIENT Approval
03/15/2013 VALACYCLOVIR HYDROCHLORIDE
ANDA #090682		 SUPPL-6 VALACYCLOVIR HYDROCHLORIDE AUROBINDO PHARMA Manufacturing (CMC) Approval
03/15/2013 DAPTOMYCIN
NDA #203797		 ORIG-1 DAPTOMYCIN HOSPIRA INC Type 5 - New Formulation or New Manufacturer Tentative Approval
03/18/2013 EXALGO
NDA #021217		 SUPPL-5 HYDROMORPHONE HYDROCHLORIDE SPECGX LLC Labeling Approval
03/18/2013 METOPROLOL TARTRATE
ANDA #074141		 SUPPL-34 METOPROLOL TARTRATE HERITAGE PHARMA Labeling Approval
03/18/2013 METOPROLOL TARTRATE
ANDA #074217		 SUPPL-25 METOPROLOL TARTRATE WATSON LABS Labeling Approval
03/18/2013 CLOMIPRAMINE HYDROCHLORIDE
ANDA #074364		 SUPPL-20 CLOMIPRAMINE HYDROCHLORIDE CHARTWELL RX Labeling Approval
03/18/2013 CLOMIPRAMINE HYDROCHLORIDE
ANDA #074947		 SUPPL-15 CLOMIPRAMINE HYDROCHLORIDE PHARMOBEDIENT Labeling Approval
03/18/2013 RIBASPHERE
ANDA #076203		 SUPPL-16 RIBAVIRIN CHARTWELL RX REMS Approval
03/18/2013 KETOCONAZOLE
ANDA #076419		 SUPPL-12 KETOCONAZOLE PADAGIS ISRAEL Labeling Approval
03/18/2013 OLANZAPINE
ANDA #076534		 SUPPL-1 OLANZAPINE DR REDDYS LABS LTD Labeling Approval
03/18/2013 METOPROLOL TARTRATE
ANDA #077739		 SUPPL-9 METOPROLOL TARTRATE AUROBINDO PHARMA Labeling Approval
03/18/2013 METOPROLOL TARTRATE
ANDA #077739		 SUPPL-11 METOPROLOL TARTRATE AUROBINDO PHARMA Labeling Approval
03/18/2013 DOXORUBICIN HYDROCHLORIDE
ANDA #091495		 ORIG-1 DOXORUBICIN HYDROCHLORIDE SAGENT PHARMS Approval
03/18/2013 ESOMEPRAZOLE SODIUM
ANDA #200882		 ORIG-1 ESOMEPRAZOLE SODIUM SUN PHARM Approval
03/18/2013 DOXYCYCLINE
ANDA #201678		 ORIG-1 DOXYCYCLINE LUPIN LTD Approval
03/19/2013 M.V.I.-12 ADULT
NDA #008809		 SUPPL-69 ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E HOSPIRA Manufacturing (CMC) Approval
03/19/2013 M.V.I.-12 ADULT
NDA #008809		 SUPPL-69 ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E HOSPIRA Manufacturing (CMC) Approval
03/19/2013 QUELICIN
NDA #008845		 SUPPL-69 SUCCINYLCHOLINE CHLORIDE HOSPIRA Manufacturing (CMC) Approval
03/19/2013 QUELICIN PRESERVATIVE FREE
NDA #008845		 SUPPL-69 SUCCINYLCHOLINE CHLORIDE HOSPIRA Manufacturing (CMC) Approval
03/19/2013 FREAMINE 8.5%
NDA #016822		 SUPPL-74 AMINO ACIDS B BRAUN Manufacturing (CMC) Approval
03/19/2013 FREAMINE HBC 6.9%
NDA #016822		 SUPPL-74 AMINO ACIDS B BRAUN Manufacturing (CMC) Approval
03/19/2013 FREAMINE II 8.5%
NDA #016822		 SUPPL-74 AMINO ACIDS B BRAUN Manufacturing (CMC) Approval
03/19/2013 FREAMINE III 10%
NDA #016822		 SUPPL-74 AMINO ACIDS B BRAUN Manufacturing (CMC) Approval
03/19/2013 FREAMINE III 3% W/ ELECTROLYTES
NDA #016822		 SUPPL-74 AMINO ACIDS; MAGNESIUM ACETATE; PHOSPHORIC ACID; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
03/19/2013 FREAMINE III 8.5%
NDA #016822		 SUPPL-74 AMINO ACIDS B BRAUN Manufacturing (CMC) Approval
03/19/2013 FREAMINE III 8.5% W/ ELECTROLYTES
NDA #016822		 SUPPL-74 AMINO ACIDS; MAGNESIUM ACETATE; PHOSPHORIC ACID; POTASSIUM ACETATE; POTASSIUM CHLORIDE; SODIUM ACETATE B BRAUN Manufacturing (CMC) Approval
03/19/2013 NEPHRAMINE 5.4%
NDA #017766		 SUPPL-36 AMINO ACIDS B BRAUN Manufacturing (CMC) Approval
03/19/2013 PROCALAMINE
NDA #018582		 SUPPL-42 AMINO ACIDS; CALCIUM ACETATE; GLYCERIN; MAGNESIUM ACETATE; PHOSPHORIC ACID; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
03/19/2013 WELLBUTRIN
NDA #018644		 SUPPL-45 BUPROPION HYDROCHLORIDE GLAXOSMITHKLINE Labeling Approval
03/19/2013 HEPATAMINE 8%
NDA #018676		 SUPPL-27 AMINO ACIDS B BRAUN Manufacturing (CMC) Approval
03/19/2013 TROPHAMINE
NDA #019018		 SUPPL-26 AMINO ACIDS B BRAUN Manufacturing (CMC) Approval
03/19/2013 TROPHAMINE 10%
NDA #019018		 SUPPL-26 AMINO ACIDS B BRAUN Manufacturing (CMC) Approval
03/19/2013 DOPAMINE HYDROCHLORIDE AND DEXTROSE 5%
NDA #019099		 SUPPL-12 DOPAMINE HYDROCHLORIDE B BRAUN Manufacturing (CMC) Approval
03/19/2013 DOPAMINE HYDROCHLORIDE AND DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019099		 SUPPL-12 DOPAMINE HYDROCHLORIDE B BRAUN Manufacturing (CMC) Approval
03/19/2013 WELLBUTRIN SR
NDA #020358		 SUPPL-52 BUPROPION HYDROCHLORIDE GLAXOSMITHKLINE Labeling Approval
03/19/2013 ZANAFLEX
NDA #020397		 SUPPL-23 TIZANIDINE HYDROCHLORIDE LEGACY Labeling Approval
03/19/2013 CUBICIN
NDA #021572		 SUPPL-41 DAPTOMYCIN CUBIST PHARMS LLC Manufacturing (CMC) Approval
03/19/2013 CUBICIN RF
NDA #021572		 SUPPL-41 DAPTOMYCIN CUBIST PHARMS LLC Manufacturing (CMC) Approval
03/19/2013 M.V.I. ADULT
NDA #021625		 SUPPL-16 ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E; VITAMIN K HOSPIRA Manufacturing (CMC) Approval
03/19/2013 M.V.I. ADULT (PHARMACY BULK PACKAGE)
NDA #021643		 SUPPL-14 ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E; VITAMIN K HOSPIRA Manufacturing (CMC) Approval
03/19/2013 QSYMIA
NDA #022580		 SUPPL-5 PHENTERMINE HYDROCHLORIDE; TOPIRAMATE VIVUS LLC Manufacturing (CMC) Approval
03/19/2013 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
ANDA #077157		 SUPPL-6 HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM TEVA PHARMS Labeling Approval
03/19/2013 ONDANSETRON HYDROCHLORIDE
ANDA #077365		 SUPPL-5 ONDANSETRON HYDROCHLORIDE HIKMA Labeling Approval
03/19/2013 ONDANSETRON HYDROCHLORIDE
ANDA #077365		 SUPPL-6 ONDANSETRON HYDROCHLORIDE HIKMA Labeling Approval
03/19/2013 LOSARTAN POTASSIUM
ANDA #077459		 SUPPL-7 LOSARTAN POTASSIUM HIKMA Labeling Approval
03/19/2013 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
ANDA #077948		 SUPPL-2 HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM CHARTWELL RX Labeling Approval
03/19/2013 LOSARTAN POTASSIUM
ANDA #078243		 SUPPL-12 LOSARTAN POTASSIUM ZYDUS PHARMS USA INC Labeling Approval
03/19/2013 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
ANDA #090528		 SUPPL-2 HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM TORRENT PHARMS Labeling Approval
03/19/2013 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
ANDA #090528		 SUPPL-6 HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM TORRENT PHARMS Labeling Approval
03/19/2013 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
ANDA #090528		 SUPPL-9 HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM TORRENT PHARMS Labeling Approval
03/19/2013 XTANDI
NDA #203415		 SUPPL-1 ENZALUTAMIDE ASTELLAS Manufacturing (CMC) Approval
03/19/2013 MECAMYLAMINE HYDROCHLORIDE
ANDA #204054		 ORIG-1 MECAMYLAMINE HYDROCHLORIDE LGM PHARMA Approval
03/20/2013 DIURIL
NDA #011145		 SUPPL-98 CHLOROTHIAZIDE RISING Manufacturing (CMC) Approval
03/20/2013 DIURIL
NDA #011145		 SUPPL-98 CHLOROTHIAZIDE SODIUM RISING Manufacturing (CMC) Approval
03/20/2013 HEPARIN SODIUM
NDA #017651		 SUPPL-57 HEPARIN SODIUM FRESENIUS KABI USA Manufacturing (CMC) Approval
03/20/2013 RYTHMOL
NDA #019151		 SUPPL-12 PROPAFENONE HYDROCHLORIDE GLAXOSMITHKLINE LLC Labeling Approval
03/20/2013 EMEND
NDA #021549		 SUPPL-19 APREPITANT MSD Labeling Approval
03/20/2013 EMEND
NDA #022023		 SUPPL-7 FOSAPREPITANT DIMEGLUMINE MERCK AND CO INC Labeling Approval
03/20/2013 ADREVIEW
NDA #022290		 SUPPL-1 IOBENGUANE SULFATE I-123 GE HEALTHCARE Efficacy Approval
03/20/2013 TIMENTIN
NDA #050590		 SUPPL-65 CLAVULANATE POTASSIUM; TICARCILLIN DISODIUM GLAXOSMITHKLINE Manufacturing (CMC) Approval
03/20/2013 TOPICORT
ANDA #074286		 SUPPL-17 DESOXIMETASONE TARO Labeling Approval
03/20/2013 CLORAZEPATE DIPOTASSIUM
ANDA #075731		 SUPPL-5 CLORAZEPATE DIPOTASSIUM TARO Labeling Approval
03/20/2013 ANAGRELIDE HYDROCHLORIDE
ANDA #076468		 SUPPL-6 ANAGRELIDE HYDROCHLORIDE CIPLA Labeling Approval
03/20/2013 ZOLPIDEM TARTRATE
ANDA #077985		 SUPPL-5 ZOLPIDEM TARTRATE SENORES PHARMS Labeling Approval
03/20/2013 ZOLPIDEM TARTRATE
ANDA #078129		 SUPPL-3 ZOLPIDEM TARTRATE HIKMA Labeling Approval
03/20/2013 NEVIRAPINE
ANDA #078584		 SUPPL-13 NEVIRAPINE HETERO LABS LTD III Labeling Approval
03/20/2013 OXALIPLATIN
ANDA #078803		 SUPPL-2 OXALIPLATIN ACTAVIS TOTOWA Labeling Approval
03/20/2013 OXALIPLATIN
ANDA #078818		 SUPPL-2 OXALIPLATIN SUN PHARM Labeling Approval
03/20/2013 VALACYCLOVIR HYDROCHLORIDE
ANDA #079012		 SUPPL-5 VALACYCLOVIR HYDROCHLORIDE RISING Labeling Approval
03/20/2013 PROGESTERONE
ANDA #200456		 SUPPL-1 PROGESTERONE SOFGEN PHARMS Labeling Approval
03/20/2013 VASCEPA
NDA #202057		 SUPPL-2 ICOSAPENT ETHYL AMARIN PHARMS Manufacturing (CMC) Approval
03/20/2013 DOTAREM
NDA #204781		 ORIG-1 GADOTERATE MEGLUMINE GUERBET Type 1 - New Molecular Entity Approval
03/21/2013 ISUPREL
NDA #010515		 SUPPL-31 ISOPROTERENOL HYDROCHLORIDE BAUSCH Manufacturing (CMC) Approval
03/21/2013 EXELON
NDA #020823		 SUPPL-30 RIVASTIGMINE TARTRATE NOVARTIS Manufacturing (CMC) Approval
03/21/2013 SINGULAIR
NDA #020829		 SUPPL-65 MONTELUKAST SODIUM ORGANON Labeling Approval
03/21/2013 SINGULAIR
NDA #020830		 SUPPL-66 MONTELUKAST SODIUM ORGANON Labeling Approval
03/21/2013 SINGULAIR
NDA #021409		 SUPPL-42 MONTELUKAST SODIUM ORGANON Labeling Approval
03/21/2013 PENTETATE CALCIUM TRISODIUM
NDA #021749		 SUPPL-8 PENTETATE CALCIUM TRISODIUM HAMELN Labeling Approval
03/21/2013 PENTETATE ZINC TRISODIUM
NDA #021751		 SUPPL-8 PENTETATE ZINC TRISODIUM HAMELN PHARMA PLUS Labeling Approval
03/21/2013 SAPHRIS
NDA #022117		 SUPPL-12 ASENAPINE MALEATE ABBVIE Labeling Approval
03/21/2013 ERYC
NDA #050536		 SUPPL-21 ERYTHROMYCIN DR REDDYS LABS SA Labeling Approval
03/21/2013 RISPERIDONE
ANDA #076288		 SUPPL-10 RISPERIDONE NATCO PHARMA USA Labeling Approval
03/21/2013 VALSARTAN AND HYDROCHLOROTHIAZIDE
ANDA #078946		 ORIG-1 HYDROCHLOROTHIAZIDE; VALSARTAN LUPIN LTD Approval
03/21/2013 VALSARTAN AND HYDROCHLOROTHIAZIDE
ANDA #091519		 ORIG-1 HYDROCHLOROTHIAZIDE; VALSARTAN WATSON LABS TEVA Approval
03/21/2013 VALSARTAN AND HYDROCHLOROTHIAZIDE
ANDA #201662		 ORIG-1 HYDROCHLOROTHIAZIDE; VALSARTAN ALEMBIC Approval
03/21/2013 VALSARTAN AND HYDROCHLOROTHIAZIDE
ANDA #202519		 ORIG-1 HYDROCHLOROTHIAZIDE; VALSARTAN AUROBINDO PHARMA LTD Approval
03/21/2013 VALSARTAN AND HYDROCHLOROTHIAZIDE
ANDA #203026		 ORIG-1 HYDROCHLOROTHIAZIDE; VALSARTAN APOTEX INC Approval
03/21/2013 PHENYLEPHRINE HYDROCHLORIDE
NDA #203510		 ORIG-1 PHENYLEPHRINE HYDROCHLORIDE PARAGON BIOTECK Type 7 - Drug Already Marketed without Approved NDA Approval
03/22/2013 8-MOP
NDA #009048		 SUPPL-45 METHOXSALEN VALEANT PHARM INTL Manufacturing (CMC) Approval
03/22/2013 OXSORALEN
NDA #009048		 SUPPL-45 METHOXSALEN VALEANT PHARM INTL Manufacturing (CMC) Approval
03/22/2013 NAPROSYN
NDA #017581		 SUPPL-111 NAPROXEN ATNAHS PHARMA US Labeling Approval
03/22/2013 ANAPROX
NDA #018164		 SUPPL-61 NAPROXEN SODIUM ATNAHS PHARMA US Labeling Approval
03/22/2013 ANAPROX DS
NDA #018164		 SUPPL-61 NAPROXEN SODIUM ATNAHS PHARMA US Labeling Approval
03/22/2013 NAPROSYN
NDA #018965		 SUPPL-20 NAPROXEN ATNAHS PHARMA US Labeling Approval
03/22/2013 CLOZARIL
NDA #019758		 SUPPL-67 CLOZAPINE HERITAGE LIFE Labeling Approval
03/22/2013 CLOZARIL
NDA #019758		 SUPPL-68 CLOZAPINE HERITAGE LIFE Labeling Approval
03/22/2013 CLOZARIL
NDA #019758		 SUPPL-70 CLOZAPINE HERITAGE LIFE Labeling Approval
03/22/2013 EC-NAPROSYN
NDA #020067		 SUPPL-18 NAPROXEN ATNAHS PHARMA US Labeling Approval
03/22/2013 CARBATROL
NDA #020712		 SUPPL-32 CARBAMAZEPINE TAKEDA PHARMS USA Labeling Approval
03/22/2013 CARBATROL
NDA #020712		 SUPPL-35 CARBAMAZEPINE TAKEDA PHARMS USA Labeling Approval
03/22/2013 OMNARIS
NDA #022004		 SUPPL-13 CICLESONIDE AZURITY Efficacy Approval
03/22/2013 DUREZOL
NDA #022212		 SUPPL-11 DIFLUPREDNATE SANDOZ Efficacy Approval
03/22/2013 SULFASALAZINE
ANDA #040349		 SUPPL-12 SULFASALAZINE NUVO PHARMS INC Labeling Approval
03/22/2013 ANCEF IN PLASTIC CONTAINER
ANDA #063002		 SUPPL-10 CEFAZOLIN SODIUM BAXTER HLTHCARE Labeling Approval
03/22/2013 CEFTRIAXONE
ANDA #065328		 SUPPL-9 CEFTRIAXONE SODIUM ACS DOBFAR Labeling Approval
03/22/2013 SULFASALAZINE
ANDA #075339		 SUPPL-12 SULFASALAZINE NUVO PHARMS INC Labeling Approval
03/22/2013 RISPERIDONE
ANDA #091537		 SUPPL-3 RISPERIDONE NATCO PHARMA USA Labeling Approval
03/22/2013 TOBI PODHALER
NDA #201688		 ORIG-1 TOBRAMYCIN VIATRIS Type 3 - New Dosage Form Approval
03/22/2013 AMYVID
NDA #202008		 SUPPL-14 FLORBETAPIR F-18 AVID RADIOPHARMS INC Manufacturing (CMC) Approval
03/22/2013 AMYVID
NDA #202008		 SUPPL-17 FLORBETAPIR F-18 AVID RADIOPHARMS INC Manufacturing (CMC) Approval
03/22/2013 SODIUM PHENYLBUTYRATE
ANDA #202819		 ORIG-1 SODIUM PHENYLBUTYRATE SIGMAPHARM LABS LLC Approval
03/23/2013 PROAIR HFA
NDA #021457		 SUPPL-29 ALBUTEROL SULFATE TEVA BRANDED PHARM Manufacturing (CMC) Approval
03/25/2013 COUMADIN
NDA #009218		 SUPPL-113 WARFARIN SODIUM BRISTOL MYERS SQUIBB Manufacturing (CMC) Approval
03/25/2013 MICRO-K
NDA #018238		 SUPPL-40 POTASSIUM CHLORIDE NESHER PHARMS Manufacturing (CMC) Approval
03/25/2013 MICRO-K 10
NDA #018238		 SUPPL-40 POTASSIUM CHLORIDE NESHER PHARMS Manufacturing (CMC) Approval
03/25/2013 HUMULIN N
BLA #018781		 SUPPL-130 INSULIN SUSP ISOPHANE RECOMBINANT HUMAN LILLY Approval
03/25/2013 DEPO-PROVERA
NDA #020246		 SUPPL-48 MEDROXYPROGESTERONE ACETATE PFIZER Manufacturing (CMC) Approval
03/25/2013 INTEGRILIN
NDA #020718		 SUPPL-37 EPTIFIBATIDE MSD SUB MERCK Labeling Approval
03/25/2013 ABILIFY
NDA #021436		 SUPPL-35 ARIPIPRAZOLE OTSUKA Manufacturing (CMC) Approval
03/25/2013 GRALISE
NDA #022544		 SUPPL-14 GABAPENTIN ALMATICA Manufacturing (CMC) Approval
03/25/2013 LOVASTATIN
ANDA #075636		 SUPPL-25 LOVASTATIN EPIC PHARMA LLC Labeling Approval
03/25/2013 SIMVASTATIN
ANDA #078034		 SUPPL-6 SIMVASTATIN BIOCON PHARMA Labeling Approval
03/25/2013 ZOLPIDEM TARTRATE
ANDA #090153		 ORIG-1 ZOLPIDEM TARTRATE ACTAVIS LABS FL INC Approval
03/25/2013 FENOFIBRIC ACID
ANDA #200913		 ORIG-1 CHOLINE FENOFIBRATE PHARMOBEDIENT Approval
03/25/2013 OLANZAPINE AND FLUOXETINE HYDROCHLORIDE
ANDA #202074		 ORIG-1 FLUOXETINE HYDROCHLORIDE; OLANZAPINE TEVA PHARMS Approval
03/25/2013 ZENATANE
ANDA #202099		 ORIG-1 ISOTRETINOIN DR REDDYS LABS LTD Approval
03/26/2013 M.V.I.-12 ADULT
NDA #008809		 SUPPL-66 ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E HOSPIRA Labeling Approval
03/26/2013 M.V.I.-12 ADULT
NDA #008809		 SUPPL-66 ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E HOSPIRA Labeling Approval
03/26/2013 TORADOL
NDA #019645		 SUPPL-19 KETOROLAC TROMETHAMINE ROCHE PALO Labeling Approval
03/26/2013 TYLENOL
NDA #019872		 SUPPL-37 ACETAMINOPHEN KENVUE BRANDS Labeling Approval
03/26/2013 MIFEPREX
NDA #020687		 SUPPL-19 MIFEPRISTONE DANCO LABS LLC Manufacturing (CMC) Approval
03/26/2013 ZORTRESS
NDA #021560		 SUPPL-10 EVEROLIMUS NOVARTIS Manufacturing (CMC) Approval
03/26/2013 CHILDREN'S CLARITIN
NDA #021891		 SUPPL-16 LORATADINE BAYER HEALTHCARE LLC Manufacturing (CMC) Approval
03/26/2013 CLARITIN
NDA #021891		 SUPPL-16 LORATADINE BAYER HEALTHCARE LLC Manufacturing (CMC) Approval
03/26/2013 AFINITOR
NDA #022334		 SUPPL-19 EVEROLIMUS NOVARTIS Manufacturing (CMC) Approval
03/26/2013 VPRIV
BLA #022575		 SUPPL-7 VELAGLUCERASE ALFA SHIRE HUMAN GENETIC Approval
03/26/2013 VPRIV
BLA #022575		 SUPPL-9 VELAGLUCERASE ALFA SHIRE HUMAN GENETIC Approval
03/26/2013 CORTISPORIN
NDA #050218		 SUPPL-62 HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE MONARCH PHARMS Manufacturing (CMC) Approval
03/26/2013 CYCLOSPORINE
ANDA #065110		 SUPPL-7 CYCLOSPORINE IVAX SUB TEVA PHARMS Labeling Approval
03/26/2013 CEFEPIME HYDROCHLORIDE
ANDA #065441		 SUPPL-14 CEFEPIME HYDROCHLORIDE ACS DOBFAR Labeling Approval
03/26/2013 RIZATRIPTAN BENZOATE
ANDA #077526		 ORIG-1 RIZATRIPTAN BENZOATE CHARTWELL RX Approval
03/26/2013 LEVOCETIRIZINE DIHYDROCHLORIDE
ANDA #090486		 ORIG-1 LEVOCETIRIZINE DIHYDROCHLORIDE GRANULES Approval
03/26/2013 FLUVASTATIN SODIUM
ANDA #090595		 SUPPL-2 FLUVASTATIN SODIUM MYLAN PHARMS INC Labeling Approval
03/26/2013 ESZOPICLONE
ANDA #091151		 ORIG-1 ESZOPICLONE MYLAN PHARMS INC Approval
03/26/2013 DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE
ANDA #091526		 ORIG-1 DIPHENHYDRAMINE HYDROCHLORIDE FRESENIUS KABI USA Approval
03/26/2013 AVASTIN
BLA #125085		 SUPPL-267 BEVACIZUMAB GENENTECH Approval
03/26/2013 NAGLAZYME
BLA #125117		 SUPPL-111 GALSULFASE BIOMARIN Approval
03/26/2013 COMPLERA
NDA #202123		 SUPPL-7 EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE GILEAD SCIENCES INC Manufacturing (CMC) Approval
03/26/2013 DYMISTA
NDA #202236		 SUPPL-3 AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE MYLAN SPECIALITY LP Manufacturing (CMC) Approval
03/26/2013 SUPRAX
NDA #203195		 SUPPL-1 CEFIXIME LUPIN LTD Manufacturing (CMC) Approval
03/26/2013 AFINITOR DISPERZ
NDA #203985		 SUPPL-1 EVEROLIMUS NOVARTIS PHARM Manufacturing (CMC) Approval
03/26/2013 ACIPHEX SPRINKLE
NDA #204736		 ORIG-1 RABEPRAZOLE SODIUM AYTU Type 3 - New Dosage Form Approval
03/27/2013 NOROXIN
NDA #019384		 SUPPL-65 NORFLOXACIN MERCK Labeling Approval
03/27/2013 COZAAR
NDA #020386		 SUPPL-58 LOSARTAN POTASSIUM ORGANON Labeling Approval
03/27/2013 HYZAAR
NDA #020387		 SUPPL-57 HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM ORGANON Labeling Approval
03/27/2013 KADIAN
NDA #020616		 SUPPL-48 MORPHINE SULFATE ALLERGAN Labeling Approval
03/27/2013 BIDIL
NDA #020727		 SUPPL-4 HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE AZURITY Labeling Approval
03/27/2013 LANTUS
BLA #021081		 SUPPL-56 INSULIN GLARGINE RECOMBINANT SANOFI AVENTIS US Approval
03/27/2013 LANTUS SOLOSTAR
BLA #021081		 SUPPL-56 INSULIN GLARGINE RECOMBINANT SANOFI AVENTIS US Approval
03/27/2013 EMEND
NDA #021549		 SUPPL-23 APREPITANT MSD Labeling Approval
03/27/2013 EMEND
NDA #022023		 SUPPL-10 FOSAPREPITANT DIMEGLUMINE MERCK AND CO INC Labeling Approval
03/27/2013 ZYPREXA RELPREVV
NDA #022173		 SUPPL-18 OLANZAPINE PAMOATE CHEPLAPHARM REMS Approval
03/27/2013 HORIZANT
NDA #022399		 SUPPL-5 GABAPENTIN ENACARBIL AZURITY Efficacy Approval
03/27/2013 MULTAQ
NDA #022425		 SUPPL-21 DRONEDARONE HYDROCHLORIDE SANOFI AVENTIS US Labeling Approval
03/27/2013 GRALISE
NDA #022544		 SUPPL-12 GABAPENTIN ALMATICA Manufacturing (CMC) Approval
03/27/2013 ZOSYN
NDA #050684		 SUPPL-78 PIPERACILLIN SODIUM; TAZOBACTAM SODIUM WYETH PHARMS Manufacturing (CMC) Approval
03/27/2013 CIPROFLOXACIN HYDROCHLORIDE
ANDA #075593		 SUPPL-19 CIPROFLOXACIN HYDROCHLORIDE DR REDDYS LABS LTD Labeling Approval
03/27/2013 ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE
ANDA #076867		 SUPPL-2 ALBUTEROL SULFATE; IPRATROPIUM BROMIDE AIPING PHARM INC Labeling Approval
03/27/2013 VORICONAZOLE
ANDA #090547		 SUPPL-2 VORICONAZOLE MYLAN PHARMS INC Labeling Approval
03/27/2013 SULFAMETHOXAZOLE AND TRIMETHOPRIM
ANDA #090828		 SUPPL-1 SULFAMETHOXAZOLE; TRIMETHOPRIM GLENMARK PHARMS LTD Labeling Approval
03/27/2013 PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #091683		 ORIG-1 PRAMIPEXOLE DIHYDROCHLORIDE SUN PHARM INDS INC Approval
03/27/2013 EPOGEN/PROCRIT
BLA #103234		 SUPPL-5329 EPOETIN ALFA AMGEN Approval
03/27/2013 ARANESP
BLA #103951		 SUPPL-5337 DARBEPOETIN ALFA AMGEN Approval
03/27/2013 AMYVID
NDA #202008		 SUPPL-15 FLORBETAPIR F-18 AVID RADIOPHARMS INC Manufacturing (CMC) Approval
03/27/2013 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #202214		 ORIG-1 ACETAMINOPHEN; HYDROCODONE BITARTRATE TRIS PHARMA INC Approval
03/27/2013 CLOPIDOGREL BISULFATE
ANDA #202925		 ORIG-1 CLOPIDOGREL BISULFATE ACCORD HLTHCARE Approval
03/27/2013 TECFIDERA
NDA #204063		 ORIG-1 DIMETHYL FUMARATE BIOGEN Type 1 - New Molecular Entity Approval
03/28/2013 XYLOCAINE
NDA #006488		 SUPPL-84 LIDOCAINE HYDROCHLORIDE FRESENIUS KABI USA Labeling Approval
03/28/2013 XYLOCAINE W/ EPINEPHRINE
NDA #006488		 SUPPL-84 EPINEPHRINE; LIDOCAINE HYDROCHLORIDE FRESENIUS KABI USA Labeling Approval
03/28/2013 XYLOCAINE 4% PRESERVATIVE FREE
NDA #010417		 SUPPL-31 LIDOCAINE HYDROCHLORIDE FRESENIUS KABI USA Labeling Approval
03/28/2013 XYLOCAINE 4% PRESERVATIVE FREE
NDA #010417		 SUPPL-32 LIDOCAINE HYDROCHLORIDE FRESENIUS KABI USA Manufacturing (CMC) Approval
03/28/2013 SYNALAR
NDA #012787		 SUPPL-71 FLUOCINOLONE ACETONIDE EUROFARMA Manufacturing (CMC) Approval
03/28/2013 XYLOCAINE PRESERVATIVE FREE
NDA #016801		 SUPPL-41 LIDOCAINE HYDROCHLORIDE FRESENIUS KABI USA Labeling Approval
03/28/2013 MOTRIN IB
NDA #019012		 SUPPL-50 IBUPROFEN KENVUE BRANDS Manufacturing (CMC) Approval
03/28/2013 MOTRIN MIGRAINE PAIN
NDA #019012		 SUPPL-50 IBUPROFEN KENVUE BRANDS Manufacturing (CMC) Approval
03/28/2013 NUPRIN
NDA #019012		 SUPPL-50 IBUPROFEN KENVUE BRANDS Manufacturing (CMC) Approval
03/28/2013 ELOCON
NDA #019543		 SUPPL-24 MOMETASONE FUROATE ORGANON Labeling Approval
03/28/2013 ELOCON
NDA #019796		 SUPPL-26 MOMETASONE FUROATE ORGANON Labeling Approval
03/28/2013 TYLENOL
NDA #019872		 SUPPL-38 ACETAMINOPHEN KENVUE BRANDS Manufacturing (CMC) Approval
03/28/2013 HUMALOG
BLA #020563		 SUPPL-137 INSULIN LISPRO RECOMBINANT LILLY Approval
03/28/2013 HUMALOG KWIKPEN
BLA #020563		 SUPPL-137 INSULIN LISPRO RECOMBINANT LILLY Approval
03/28/2013 HUMALOG PEN
BLA #020563		 SUPPL-137 INSULIN LISPRO RECOMBINANT LILLY Approval
03/28/2013 HUMALOG TEMPO PEN
BLA #020563		 SUPPL-137 INSULIN LISPRO RECOMBINANT LILLY Approval
03/28/2013 HUMALOG MIX 75/25
BLA #021017		 SUPPL-91 INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT LILLY Approval
03/28/2013 HUMALOG MIX 75/25 KWIKPEN
BLA #021017		 SUPPL-91 INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT LILLY Approval
03/28/2013 HUMALOG MIX 75/25 PEN
BLA #021017		 SUPPL-91 INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT LILLY Approval
03/28/2013 HUMALOG MIX 50/50
BLA #021018		 SUPPL-85 INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT LILLY Approval
03/28/2013 HUMALOG MIX 50/50 KWIKPEN
BLA #021018		 SUPPL-85 INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT LILLY Approval
03/28/2013 HUMALOG MIX 50/50 PEN
BLA #021018		 SUPPL-85 INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT LILLY Approval
03/28/2013 VALCYTE
NDA #021304		 SUPPL-10 VALGANCICLOVIR HYDROCHLORIDE CHEPLAPHARM Labeling Approval
03/28/2013 VIVITROL
NDA #021897		 SUPPL-21 NALTREXONE ALKERMES Manufacturing (CMC) Approval
03/28/2013 VALCYTE
NDA #022257		 SUPPL-4 VALGANCICLOVIR HYDROCHLORIDE CHEPLAPHARM Labeling Approval
03/28/2013 GRALISE
NDA #022544		 SUPPL-16 GABAPENTIN ALMATICA Manufacturing (CMC) Approval
03/28/2013 KARBINAL ER
NDA #022556		 ORIG-1 CARBINOXAMINE MALEATE AYTU Type 3 - New Dosage Form Approval
03/28/2013 MERREM IV
NDA #050706		 SUPPL-31 MEROPENEM PFIZER Labeling Approval
03/28/2013 KETOROLAC TROMETHAMINE
ANDA #076109		 SUPPL-1 KETOROLAC TROMETHAMINE APOTEX Manufacturing (CMC) Approval
03/28/2013 CITALOPRAM HYDROBROMIDE
ANDA #077035		 SUPPL-11 CITALOPRAM HYDROBROMIDE FOSUN PHARMA Labeling Approval
03/28/2013 VIVACAINE
ANDA #077250		 SUPPL-9 BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE SEPTODONT Labeling Approval
03/28/2013 KETOROLAC TROMETHAMINE
ANDA #077308		 SUPPL-1 KETOROLAC TROMETHAMINE APOTEX Manufacturing (CMC) Approval
03/28/2013 CITALOPRAM HYDROBROMIDE
ANDA #078216		 SUPPL-20 CITALOPRAM HYDROBROMIDE TORRENT PHARMS Labeling Approval
03/28/2013 AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
ANDA #078652		 ORIG-1 AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE ZYDUS PHARMS USA INC Tentative Approval
03/28/2013 AMLODIPINE BESYLATE AND VALSARTAN
ANDA #090011		 ORIG-1 AMLODIPINE BESYLATE; VALSARTAN STRIDES PHARMA INTL Approval
03/28/2013 CYPROHEPTADINE HYDROCHLORIDE
ANDA #091295		 ORIG-1 CYPROHEPTADINE HYDROCHLORIDE PHARM ASSOC Approval
03/28/2013 JENCYCLA
ANDA #091323		 ORIG-1 NORETHINDRONE LUPIN LTD Approval
03/28/2013 VIORELE
ANDA #091346		 SUPPL-1 DESOGESTREL; ETHINYL ESTRADIOL GLENMARK PHARMS LTD Labeling Approval
03/28/2013 INDOMETHACIN
ANDA #091401		 ORIG-1 INDOMETHACIN SUN PHARM INDS INC Approval
03/28/2013 REMICADE
BLA #103772		 SUPPL-5345 INFLIXIMAB CENTOCOR INC Approval
03/28/2013 VECTIBIX
BLA #125147		 SUPPL-169 PANITUMUMAB AMGEN Approval
03/28/2013 NORGESTIMATE AND ETHINYL ESTRADIOL
ANDA #200494		 SUPPL-5 ETHINYL ESTRADIOL; NORGESTIMATE GLENMARK PHARMS LTD Labeling Approval
03/28/2013 NORGESTIMATE; ETHINYL ESTRADIOL
ANDA #200494		 SUPPL-5 NORGESTIMATE; ETHINYL ESTRADIOL GLENMARK PHARMS LTD Labeling Approval
03/28/2013 NORGESTIMATE AND ETHINYL ESTRADIOL
ANDA #200538		 SUPPL-2 ETHINYL ESTRADIOL; NORGESTIMATE GLENMARK PHARMS LTD Labeling Approval
03/28/2013 NITHIODOTE
NDA #201444		 SUPPL-9 SODIUM NITRITE; SODIUM THIOSULFATE HOPE PHARMS Manufacturing (CMC) Approval
03/28/2013 HYDRALAZINE HYDROCHLORIDE
ANDA #202938		 ORIG-1 HYDRALAZINE HYDROCHLORIDE NAVINTA LLC Approval
03/28/2013 QUARTETTE
NDA #204061		 ORIG-1 ETHINYL ESTRADIOL; LEVONORGESTREL TEVA BRANDED PHARM Type 5 - New Formulation or New Manufacturer Approval
03/29/2013 FORADIL
NDA #020831		 SUPPL-29 FORMOTEROL FUMARATE NOVARTIS Labeling Approval
03/29/2013 FORADIL
NDA #020831		 SUPPL-32 FORMOTEROL FUMARATE NOVARTIS REMS Approval
03/29/2013 VENOFER
NDA #021135		 SUPPL-23 IRON SUCROSE AM REGENT Manufacturing (CMC) Approval
03/29/2013 VESICARE
NDA #021518		 SUPPL-15 SOLIFENACIN SUCCINATE ASTELLAS Labeling Approval
03/29/2013 SALONPAS
NDA #022029		 SUPPL-12 MENTHOL; METHYL SALICYLATE HISAMITSU PHARM CO Efficacy Approval
03/29/2013 BRILINTA
NDA #022433		 SUPPL-8 TICAGRELOR ASTRAZENECA Labeling Approval
03/29/2013 SUPRAX
ANDA #065129		 SUPPL-25 CEFIXIME LUPIN PHARMS Labeling Approval
03/29/2013 SUPRAX
ANDA #065130		 SUPPL-16 CEFIXIME LUPIN PHARMS Labeling Approval
03/29/2013 SUPRAX
ANDA #065355		 SUPPL-18 CEFIXIME LUPIN PHARMS Labeling Approval
03/29/2013 SUPRAX
ANDA #065380		 SUPPL-2 CEFIXIME LUPIN LTD Labeling Approval
03/29/2013 DESOGESTREL AND ETHINYL ESTRADIOL
ANDA #076916		 SUPPL-6 DESOGESTREL; ETHINYL ESTRADIOL DR REDDYS LABS SA Labeling Approval
03/29/2013 ALENDRONATE SODIUM
ANDA #090258		 SUPPL-2 ALENDRONATE SODIUM HANGZHOU BINJIANG Manufacturing (CMC) Approval
03/29/2013 HEATHER
ANDA #090454		 SUPPL-4 NORETHINDRONE GLENMARK PHARMS LTD Labeling Approval
03/29/2013 NORETHINDRONE
ANDA #091209		 SUPPL-3 NORETHINDRONE GLENMARK PHARMS LTD Labeling Approval
03/29/2013 ZOLEDRONIC ACID
ANDA #091363		 ORIG-1 ZOLEDRONIC ACID DR REDDYS LABS LTD Approval
03/29/2013 TRAMADOL HYDROCHLORIDE
ANDA #091498		 ORIG-1 TRAMADOL HYDROCHLORIDE CSPC OUYI PHARM CO Approval
03/29/2013 METHYLERGONOVINE MALEATE
ANDA #091577		 SUPPL-1 METHYLERGONOVINE MALEATE CHARTWELL RX Labeling Approval
03/29/2013 ALYACEN 1/35
ANDA #091634		 SUPPL-2 ETHINYL ESTRADIOL; NORETHINDRONE GLENMARK PHARMS LTD Labeling Approval
03/29/2013 ALYACEN 7/7/7
ANDA #091636		 SUPPL-2 ETHINYL ESTRADIOL; NORETHINDRONE GLENMARK PHARMS LTD Labeling Approval
03/29/2013 ALYACEN 777
ANDA #091636		 SUPPL-2 NORETHINDRONE; ETHINYL ESTRADIOL GLENMARK PHARMS LTD Labeling Approval
03/29/2013 VORAXAZE
BLA #125327		 SUPPL-20 GLUCARPIDASE BTG INTERNATIONAL INC Approval
03/29/2013 ZOLEDRONIC ACID
ANDA #201801		 ORIG-1 ZOLEDRONIC ACID AVET LIFESCIENCES Approval
03/29/2013 INVOKANA
NDA #204042		 ORIG-1 CANAGLIFLOZIN JANSSEN PHARMS Type 1 - New Molecular Entity Approval
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