Drugs@FDA: FDA Approved Drug Products

Recent New and Generic Drug Approvals

This report displays final approvals and tentative approvals of original and supplemental applications for the two weeks beginning on the earliest date listed below. Some approvals may be added to the Drugs@FDA database after this timespan. For comprehensive approval reports, please use the monthly "All Approvals" report on Drugs@FDA.

January 22, 2019

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Abiraterone Acetate
ANDA #209227
Abiraterone Acetate Unknown ORIG-1 Glenmark Pharms Sa Tentative Approval
Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate
ANDA #205401
Amphetamine Aspartate;Amphetamine Sulfate;Dextroamphetamine Saccharate;Dextroamphetamine Sulfate Unknown ORIG-1 Amerigen Pharms Ltd Approved
Prandin
NDA #020741
Repaglinide Tablet; Oral SUPPL-44 Gemini Labs Llc Labeling Approved
Revlimid
NDA #021880
Lenalidomide Capsule; Oral SUPPL-56 Celgene Labeling Approved

January 18, 2019

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Acyclovir
ANDA #211794
Acyclovir Ointment; Topical ORIG-1 Cipla Approved
Carfilzomib
ANDA #209425
Carfilzomib Unknown ORIG-1 Apotex Inc Tentative Approval
Carfilzomib
ANDA #209528
Carfilzomib Unknown ORIG-1 Qilu Pharm Co Ltd Tentative Approval
Cyclophosphamide
ANDA #211608
Cyclophosphamide Capsule; Oral ORIG-1 Cipla Approved
Dapagliflozin
ANDA #211439
Dapagliflozin Unknown ORIG-1 Hetero Labs Unit Iii Tentative Approval
Dexmedetomidine Hydrochloride
ANDA #204843
Dexmedetomidine Hydrochloride Injectable; Injection ORIG-1 Cipla Approved
Egrifta
NDA #022505
Tesamorelin Acetate Powder; Subcutaneous SUPPL-11 Theratechnologies Labeling Approved
Entocort Ec
NDA #021324
Budesonide Capsule; Oral SUPPL-18 Perrigo Pharma Intl Labeling Approved
Erivedge
NDA #203388
Vismodegib Capsule; Oral SUPPL-12 Genentech Efficacy Approved
Esomeprazole Magnesium
ANDA #206296
Esomeprazole Magnesium Unknown ORIG-1 Zydus Pharms Usa Inc Tentative Approval
Increlex
NDA #021839
Mecasermin Recombinant Injectable; Subcutaneous SUPPL-21 Ipsen Inc Labeling Approved
Lansoprazole
ANDA #207394
Lansoprazole Capsule, Delayed Rel Pellets; Oral ORIG-1 Alkem Labs Ltd Approved
Levothyroxine Sodium
ANDA #209713
Levothyroxine Sodium Tablet; Oral ORIG-1 Lupin Atlantis Approved
Libtayo
BLA #761097
Cemiplimab-Rwlc Injectable; Intravenous SUPPL-2 Regeneron Pharmaceuticals Labeling Approved
Methimazole
ANDA #040350
Methimazole Tablet; Oral SUPPL-23 Mylan Labeling Approved
Methimazole
ANDA #040411
Methimazole Tablet; Oral SUPPL-28 Casi Pharms Inc Labeling Approved
Methimazole
ANDA #040547
Methimazole Tablet; Oral SUPPL-11 Eci Pharms Llc Labeling Approved
Methimazole
ANDA #040547
Methimazole Tablet; Oral SUPPL-11 Eci Pharms Llc Labeling Approved
Methimazole
ANDA #040619
Methimazole Tablet; Oral SUPPL-4 Eci Pharms Llc Labeling Approved
Methimazole
ANDA #040734
Methimazole Tablet; Oral SUPPL-7 Heritage Pharma Labeling Approved
Methimazole
ANDA #040870
Methimazole Tablet; Oral SUPPL-8 Sun Pharm Inds Inc Labeling Approved
Moxidectin
NDA #210867
Moxidectin Tablet; Oral SUPPL-1 Mdgh Labeling Approved
Neupro
NDA #021829
Rotigotine Film, Extended Release; Transdermal SUPPL-16 Ucb Inc Labeling Approved
Ontruzant
BLA #761100
Trastuzumab-Dttb Injectable; Injection ORIG-1 Samsung Bioepis Co Ltd Approved
Retacrit
BLA #125545
Epoetin Alfa-Epbx Injectable; Injection SUPPL-3 Hospira Inc Labeling Approved
Tapazole
ANDA #040320
Methimazole Tablet; Oral SUPPL-12 King Pharms Llc Labeling Approved

January 17, 2019

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Aldactazide
NDA #012616
Hydrochlorothiazide; Spironolactone Tablet; Oral SUPPL-78 Gd Searle Llc Labeling Approved
Atorvastatin Calcium
ANDA #090548
Atorvastatin Calcium Tablet; Oral SUPPL-19 Apotex Inc Labeling Approved
Atorvastatin Calcium
ANDA #090548
Atorvastatin Calcium Tablet; Oral SUPPL-19 Apotex Inc Labeling Approved
Imatinib Mesylate
ANDA #208302
Imatinib Mesylate Tablet; Oral ORIG-1 Shilpa Medicare Ltd Approved
Imatinib Mesylate
ANDA #208429
Imatinib Mesylate Tablet; Oral ORIG-1 Wockhardt Bio Ag Approved
Levemir
NDA #021536
Insulin Detemir Recombinant Injectable; Subcutaneous SUPPL-54 Novo Nordisk Inc Labeling Approved
Levemir
NDA #021536
Insulin Detemir Recombinant Injectable; Subcutaneous SUPPL-54 Novo Nordisk Inc Labeling Approved
Levemir
NDA #021536
Insulin Detemir Recombinant Injectable; Subcutaneous SUPPL-54 Novo Nordisk Inc Labeling Approved
Levemir Flexpen
NDA #021536
Insulin Detemir Recombinant Injectable; Subcutaneous SUPPL-54 Novo Nordisk Inc Labeling Approved
Levemir Flexpen
NDA #021536
Insulin Detemir Recombinant Injectable; Subcutaneous SUPPL-54 Novo Nordisk Inc Labeling Approved
Levemir Flexpen
NDA #021536
Insulin Detemir Recombinant Injectable; Subcutaneous SUPPL-54 Novo Nordisk Inc Labeling Approved
Levemir Flextouch
NDA #021536
Insulin Detemir Recombinant Injectable; Subcutaneous SUPPL-54 Novo Nordisk Inc Labeling Approved
Levemir Flextouch
NDA #021536
Insulin Detemir Recombinant Injectable; Subcutaneous SUPPL-54 Novo Nordisk Inc Labeling Approved
Levemir Flextouch
NDA #021536
Insulin Detemir Recombinant Injectable; Subcutaneous SUPPL-54 Novo Nordisk Inc Labeling Approved
Levemir Innolet
NDA #021536
Insulin Detemir Recombinant Injectable; Subcutaneous SUPPL-54 Novo Nordisk Inc Labeling Approved
Levemir Innolet
NDA #021536
Insulin Detemir Recombinant Injectable; Subcutaneous SUPPL-54 Novo Nordisk Inc Labeling Approved
Levemir Innolet
NDA #021536
Insulin Detemir Recombinant Injectable; Subcutaneous SUPPL-54 Novo Nordisk Inc Labeling Approved
Levemir Penfill
NDA #021536
Insulin Detemir Recombinant Injectable; Subcutaneous SUPPL-54 Novo Nordisk Inc Labeling Approved
Levemir Penfill
NDA #021536
Insulin Detemir Recombinant Injectable; Subcutaneous SUPPL-54 Novo Nordisk Inc Labeling Approved
Levemir Penfill
NDA #021536
Insulin Detemir Recombinant Injectable; Subcutaneous SUPPL-54 Novo Nordisk Inc Labeling Approved
Revatio
NDA #022473
Sildenafil Citrate Solution; Intravenous SUPPL-12 Pfizer Labeling Approved
Revatio
NDA #203109
Sildenafil Citrate For Suspension; Oral SUPPL-12 Pfizer Labeling Approved

January 16, 2019

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Acetazolamide
ANDA #205301
Acetazolamide Capsule, Extended Release; Oral ORIG-1 Xylopia Approved
Campath
BLA #103948
Alemtuzumab Vial; Intravenous SUPPL-5163 Genzyme Labeling Approved
Campath
BLA #103948
Alemtuzumab Vial; Intravenous SUPPL-5164 Genzyme Labeling Approved
Campath
BLA #103948
Alemtuzumab Vial; Intravenous SUPPL-5163 Genzyme Labeling Approved
Campath
BLA #103948
Alemtuzumab Vial; Intravenous SUPPL-5164 Genzyme Labeling Approved
Capastat Sulfate
NDA #050095
Capreomycin Sulfate Injectable; Injection SUPPL-72 Akorn Labeling Approved
Clozapine
ANDA #074949
Clozapine Tablet; Oral SUPPL-75 Ivax Sub Teva Pharms REMS Approved
Clozapine
ANDA #075417
Clozapine Tablet; Oral SUPPL-41 Mylan REMS Approved
Clozapine
ANDA #075713
Clozapine Tablet; Oral SUPPL-45 Sun Pharm Inds Inc REMS Approved
Clozapine
ANDA #076809
Clozapine Tablet; Oral SUPPL-38 Ivax Sub Teva Pharms REMS Approved
Clozapine
ANDA #090308
Clozapine Tablet, Orally Disintegrating; Oral SUPPL-3 Barr Labs Inc REMS Approved
Clozapine
ANDA #201824
Clozapine Tablet, Orally Disintegrating; Oral SUPPL-9 Mylan Pharms Inc REMS Approved
Clozapine
ANDA #202873
Clozapine Tablet; Oral SUPPL-5 Accord Hlthcare REMS Approved
Clozapine
ANDA #203039
Clozapine Tablet, Orally Disintegrating; Oral SUPPL-5 Teva Pharms Usa REMS Approved
Clozapine
ANDA #203807
Clozapine Tablet; Oral SUPPL-6 Mayne Pharma REMS Approved
Clozapine
ANDA #206433
Clozapine Tablet; Oral SUPPL-4 Aurobindo Pharma Ltd REMS Approved
Clozaril
NDA #019758
Clozapine Tablet; Oral SUPPL-90 Heritage Life REMS Approved
Fazaclo Odt
NDA #021590
Clozapine Tablet, Orally Disintegrating; Oral SUPPL-31 Jazz Pharms Iii REMS Approved
Isosulfan Blue
ANDA #210714
Isosulfan Blue Injectable; Injection ORIG-1 Beloteca Inc Approved
Lemtrada
BLA #103948
Alemtuzumab Injectable; Injection SUPPL-5163 Genzyme Labeling Approved
Lemtrada
BLA #103948
Alemtuzumab Injectable; Injection SUPPL-5164 Genzyme Labeling Approved
Lemtrada
BLA #103948
Alemtuzumab Injectable; Injection SUPPL-5163 Genzyme Labeling Approved
Lemtrada
BLA #103948
Alemtuzumab Injectable; Injection SUPPL-5164 Genzyme Labeling Approved
Lioresal
NDA #020075
Baclofen Injectable; Intrathecal SUPPL-37 Saol Theraps Res Ltd Labeling Approved
Prasugrel
ANDA #206021
Prasugrel Hydrochloride Tablet; Oral ORIG-1 Hec Pharm Approved
Prevantics Maxi Swabstick
NDA #021524
Chlorhexidine Gluconate; Isopropyl Alcohol Swab; Topical SUPPL-20 Prof Dspls Labeling Approved
Prevantics Swab
NDA #021524
Chlorhexidine Gluconate; Isopropyl Alcohol Swab; Topical SUPPL-20 Prof Dspls Labeling Approved
Prevantics Swabstick
NDA #021524
Chlorhexidine Gluconate; Isopropyl Alcohol Swab; Topical SUPPL-20 Prof Dspls Labeling Approved
Trientine Hydrochloride
ANDA #211251
Trientine Hydrochloride Capsule; Oral ORIG-1 Navinta Llc Approved
Tylenol
NDA #019872
Acetaminophen Tablet, Extended Release; Oral SUPPL-48 J and J Consumer Inc Labeling Approved
Versacloz
NDA #203479
Clozapine Suspension; Oral SUPPL-11 Tasman Pharma REMS Approved
Welchol
NDA #021176
Colesevelam Hydrochloride Tablet; Oral SUPPL-44 Daiichi Sankyo Labeling Approved
Welchol
NDA #022362
Colesevelam Hydrochloride For Suspension; Oral SUPPL-23 Daiichi Sankyo Labeling Approved

January 15, 2019

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Alendronate Sodium
ANDA #076768
Alendronate Sodium Tablet; Oral SUPPL-7 Cipla Labeling Approved
Cytarabine
ANDA #071868
Cytarabine Injectable; Injection SUPPL-31 Hospira Labeling Approved
Cytarabine
ANDA #071868
Cytarabine Injectable; Injection SUPPL-29 Hospira Labeling Approved
Cytarabine
ANDA #071868
Cytarabine Injectable; Injection SUPPL-30 Hospira Labeling Approved
Cytarabine
ANDA #072168
Cytarabine Injectable; Injection SUPPL-29 Hospira Labeling Approved
Cytarabine
ANDA #072168
Cytarabine Injectable; Injection SUPPL-28 Hospira Labeling Approved
Cytarabine
ANDA #072945
Cytarabine Injectable; Injection SUPPL-24 Hospira Labeling Approved
Cytarabine
ANDA #075383
Cytarabine Injectable; Injection SUPPL-17 Hospira Labeling Approved
Dexedrine
NDA #017078
Dextroamphetamine Sulfate Capsule, Extended Release; Oral SUPPL-52 Impax Labs Inc Labeling Approved
Eletriptan Hydrobromide
ANDA #210708
Eletriptan Hydrobromide Tablet; Oral ORIG-1 Aurobindo Pharma Ltd Approved
Hydroxychloroquine Sulfate
ANDA #210959
Hydroxychloroquine Sulfate Tablet; Oral ORIG-1 Rising Pharms Approved
Polocaine
ANDA #088653
Mepivacaine Hydrochloride Injectable; Injection SUPPL-12 Dentsply Pharm Labeling Approved
Polocaine W/ Levonordefrin
ANDA #089517
Levonordefrin; Mepivacaine Hydrochloride Injectable; Injection SUPPL-6 Dentsply Pharm Labeling Approved
Rufinamide
ANDA #207363
Rufinamide Unknown ORIG-1 West-Ward Pharms Int Tentative Approval
Sudafed 12 Hour
ANDA #073585
Pseudoephedrine Hydrochloride Tablet, Extended Release; Oral SUPPL-20 Mcneil Cons Labeling Approved
Trulicity
BLA #125469
Dulaglutide Injectable; Injection SUPPL-23 Eli Lilly and Co Efficacy Approved
Xarelto
NDA #022406
Rivaroxaban Tablet; Oral SUPPL-30 Janssen Pharms Labeling Approved
Xarelto
NDA #022406
Rivaroxaban Tablet; Oral SUPPL-32 Janssen Pharms Labeling Approved
Zegerid Otc
NDA #022281
Omeprazole; Sodium Bicarbonate Capsule; Oral SUPPL-13 Bayer Healthcare Llc Labeling Approved
Zegerid Otc
NDA #022283
Omeprazole; Sodium Bicarbonate For Suspension; Oral SUPPL-3 Bayer Healthcare Llc Labeling Approved
Zegerid Otc
NDA #022283
Omeprazole; Sodium Bicarbonate For Suspension; Oral SUPPL-3 Bayer Healthcare Llc Labeling Approved

January 14, 2019

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Alosetron Hydrochloride
ANDA #209180
Alosetron Hydrochloride Tablet; Oral ORIG-1 Cipla Approved
Busulfan
ANDA #207794
Busulfan Injectable; Injection ORIG-1 Nexus Pharms Approved
Cabometyx
NDA #208692
Cabozantinib S-Malate Tablet; Oral SUPPL-3 Exelixis Inc Efficacy Approved
Hydrochlorothiazide
ANDA #203561
Hydrochlorothiazide Capsule; Oral ORIG-1 Sciegen Pharms Inc Approved
Metformin Hydrochloride
ANDA #075973
Metformin Hydrochloride Tablet; Oral SUPPL-19 Mylan Labeling Approved
Metformin Hydrochloride
ANDA #075973
Metformin Hydrochloride Tablet; Oral SUPPL-20 Mylan Labeling Approved
Metformin Hydrochloride
ANDA #075973
Metformin Hydrochloride Tablet; Oral SUPPL-20 Mylan Labeling Approved
Metformin Hydrochloride
ANDA #209313
Metformin Hydrochloride Tablet, Extended Release; Oral SUPPL-1 Granules India Ltd Labeling Approved
Pioglitazone Hydrochloride
ANDA #078670
Pioglitazone Hydrochloride Tablet; Oral SUPPL-4 Sandoz Labeling Approved
Pioglitazone Hydrochloride
ANDA #078670
Pioglitazone Hydrochloride Tablet; Oral SUPPL-4 Sandoz Labeling Approved
Pioglitazone Hydrochloride
ANDA #078670
Pioglitazone Hydrochloride Tablet; Oral SUPPL-5 Sandoz Labeling Approved
Vigabatrin
ANDA #209822
Vigabatrin Tablet; Oral ORIG-1 Teva Pharms Usa Approved

January 22, 2019

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Abiraterone Acetate
ANDA #209227
Abiraterone Acetate Unknown ORIG-1 Glenmark Pharms Sa Tentative Approval
Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate
ANDA #205401
Amphetamine Aspartate;Amphetamine Sulfate;Dextroamphetamine Saccharate;Dextroamphetamine Sulfate Unknown ORIG-1 Amerigen Pharms Ltd Approved
Prandin
NDA #020741
Repaglinide Tablet; Oral SUPPL-44 Gemini Labs Llc Labeling Approved
Revlimid
NDA #021880
Lenalidomide Capsule; Oral SUPPL-56 Celgene Labeling Approved

January 18, 2019

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Acyclovir
ANDA #211794
Acyclovir Ointment; Topical ORIG-1 Cipla Approved
Carfilzomib
ANDA #209425
Carfilzomib Unknown ORIG-1 Apotex Inc Tentative Approval
Carfilzomib
ANDA #209528
Carfilzomib Unknown ORIG-1 Qilu Pharm Co Ltd Tentative Approval
Cyclophosphamide
ANDA #211608
Cyclophosphamide Capsule; Oral ORIG-1 Cipla Approved
Dapagliflozin
ANDA #211439
Dapagliflozin Unknown ORIG-1 Hetero Labs Unit Iii Tentative Approval
Dexmedetomidine Hydrochloride
ANDA #204843
Dexmedetomidine Hydrochloride Injectable; Injection ORIG-1 Cipla Approved
Egrifta
NDA #022505
Tesamorelin Acetate Powder; Subcutaneous SUPPL-11 Theratechnologies Labeling Approved
Entocort Ec
NDA #021324
Budesonide Capsule; Oral SUPPL-18 Perrigo Pharma Intl Labeling Approved
Erivedge
NDA #203388
Vismodegib Capsule; Oral SUPPL-12 Genentech Efficacy Approved
Esomeprazole Magnesium
ANDA #206296
Esomeprazole Magnesium Unknown ORIG-1 Zydus Pharms Usa Inc Tentative Approval
Increlex
NDA #021839
Mecasermin Recombinant Injectable; Subcutaneous SUPPL-21 Ipsen Inc Labeling Approved
Lansoprazole
ANDA #207394
Lansoprazole Capsule, Delayed Rel Pellets; Oral ORIG-1 Alkem Labs Ltd Approved
Levothyroxine Sodium
ANDA #209713
Levothyroxine Sodium Tablet; Oral ORIG-1 Lupin Atlantis Approved
Libtayo
BLA #761097
Cemiplimab-Rwlc Injectable; Intravenous SUPPL-2 Regeneron Pharmaceuticals Labeling Approved
Methimazole
ANDA #040350
Methimazole Tablet; Oral SUPPL-23 Mylan Labeling Approved
Methimazole
ANDA #040411
Methimazole Tablet; Oral SUPPL-28 Casi Pharms Inc Labeling Approved
Methimazole
ANDA #040547
Methimazole Tablet; Oral SUPPL-11 Eci Pharms Llc Labeling Approved
Methimazole
ANDA #040547
Methimazole Tablet; Oral SUPPL-11 Eci Pharms Llc Labeling Approved
Methimazole
ANDA #040619
Methimazole Tablet; Oral SUPPL-4 Eci Pharms Llc Labeling Approved
Methimazole
ANDA #040734
Methimazole Tablet; Oral SUPPL-7 Heritage Pharma Labeling Approved
Methimazole
ANDA #040870
Methimazole Tablet; Oral SUPPL-8 Sun Pharm Inds Inc Labeling Approved
Moxidectin
NDA #210867
Moxidectin Tablet; Oral SUPPL-1 Mdgh Labeling Approved
Neupro
NDA #021829
Rotigotine Film, Extended Release; Transdermal SUPPL-16 Ucb Inc Labeling Approved
Ontruzant
BLA #761100
Trastuzumab-Dttb Injectable; Injection ORIG-1 Samsung Bioepis Co Ltd Approved
Retacrit
BLA #125545
Epoetin Alfa-Epbx Injectable; Injection SUPPL-3 Hospira Inc Labeling Approved
Tapazole
ANDA #040320
Methimazole Tablet; Oral SUPPL-12 King Pharms Llc Labeling Approved

January 17, 2019

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Aldactazide
NDA #012616
Hydrochlorothiazide; Spironolactone Tablet; Oral SUPPL-78 Gd Searle Llc Labeling Approved
Atorvastatin Calcium
ANDA #090548
Atorvastatin Calcium Tablet; Oral SUPPL-19 Apotex Inc Labeling Approved
Atorvastatin Calcium
ANDA #090548
Atorvastatin Calcium Tablet; Oral SUPPL-19 Apotex Inc Labeling Approved
Imatinib Mesylate
ANDA #208302
Imatinib Mesylate Tablet; Oral ORIG-1 Shilpa Medicare Ltd Approved
Imatinib Mesylate
ANDA #208429
Imatinib Mesylate Tablet; Oral ORIG-1 Wockhardt Bio Ag Approved
Levemir
NDA #021536
Insulin Detemir Recombinant Injectable; Subcutaneous SUPPL-54 Novo Nordisk Inc Labeling Approved
Levemir
NDA #021536
Insulin Detemir Recombinant Injectable; Subcutaneous SUPPL-54 Novo Nordisk Inc Labeling Approved
Levemir
NDA #021536
Insulin Detemir Recombinant Injectable; Subcutaneous SUPPL-54 Novo Nordisk Inc Labeling Approved
Levemir Flexpen
NDA #021536
Insulin Detemir Recombinant Injectable; Subcutaneous SUPPL-54 Novo Nordisk Inc Labeling Approved
Levemir Flexpen
NDA #021536
Insulin Detemir Recombinant Injectable; Subcutaneous SUPPL-54 Novo Nordisk Inc Labeling Approved
Levemir Flexpen
NDA #021536
Insulin Detemir Recombinant Injectable; Subcutaneous SUPPL-54 Novo Nordisk Inc Labeling Approved
Levemir Flextouch
NDA #021536
Insulin Detemir Recombinant Injectable; Subcutaneous SUPPL-54 Novo Nordisk Inc Labeling Approved
Levemir Flextouch
NDA #021536
Insulin Detemir Recombinant Injectable; Subcutaneous SUPPL-54 Novo Nordisk Inc Labeling Approved
Levemir Flextouch
NDA #021536
Insulin Detemir Recombinant Injectable; Subcutaneous SUPPL-54 Novo Nordisk Inc Labeling Approved
Levemir Innolet
NDA #021536
Insulin Detemir Recombinant Injectable; Subcutaneous SUPPL-54 Novo Nordisk Inc Labeling Approved
Levemir Innolet
NDA #021536
Insulin Detemir Recombinant Injectable; Subcutaneous SUPPL-54 Novo Nordisk Inc Labeling Approved
Levemir Innolet
NDA #021536
Insulin Detemir Recombinant Injectable; Subcutaneous SUPPL-54 Novo Nordisk Inc Labeling Approved
Levemir Penfill
NDA #021536
Insulin Detemir Recombinant Injectable; Subcutaneous SUPPL-54 Novo Nordisk Inc Labeling Approved
Levemir Penfill
NDA #021536
Insulin Detemir Recombinant Injectable; Subcutaneous SUPPL-54 Novo Nordisk Inc Labeling Approved
Levemir Penfill
NDA #021536
Insulin Detemir Recombinant Injectable; Subcutaneous SUPPL-54 Novo Nordisk Inc Labeling Approved
Revatio
NDA #022473
Sildenafil Citrate Solution; Intravenous SUPPL-12 Pfizer Labeling Approved
Revatio
NDA #203109
Sildenafil Citrate For Suspension; Oral SUPPL-12 Pfizer Labeling Approved

January 16, 2019

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Acetazolamide
ANDA #205301
Acetazolamide Capsule, Extended Release; Oral ORIG-1 Xylopia Approved
Campath
BLA #103948
Alemtuzumab Vial; Intravenous SUPPL-5163 Genzyme Labeling Approved
Campath
BLA #103948
Alemtuzumab Vial; Intravenous SUPPL-5164 Genzyme Labeling Approved
Campath
BLA #103948
Alemtuzumab Vial; Intravenous SUPPL-5163 Genzyme Labeling Approved
Campath
BLA #103948
Alemtuzumab Vial; Intravenous SUPPL-5164 Genzyme Labeling Approved
Capastat Sulfate
NDA #050095
Capreomycin Sulfate Injectable; Injection SUPPL-72 Akorn Labeling Approved
Clozapine
ANDA #074949
Clozapine Tablet; Oral SUPPL-75 Ivax Sub Teva Pharms REMS Approved
Clozapine
ANDA #075417
Clozapine Tablet; Oral SUPPL-41 Mylan REMS Approved
Clozapine
ANDA #075713
Clozapine Tablet; Oral SUPPL-45 Sun Pharm Inds Inc REMS Approved
Clozapine
ANDA #076809
Clozapine Tablet; Oral SUPPL-38 Ivax Sub Teva Pharms REMS Approved
Clozapine
ANDA #090308
Clozapine Tablet, Orally Disintegrating; Oral SUPPL-3 Barr Labs Inc REMS Approved
Clozapine
ANDA #201824
Clozapine Tablet, Orally Disintegrating; Oral SUPPL-9 Mylan Pharms Inc REMS Approved
Clozapine
ANDA #202873
Clozapine Tablet; Oral SUPPL-5 Accord Hlthcare REMS Approved
Clozapine
ANDA #203039
Clozapine Tablet, Orally Disintegrating; Oral SUPPL-5 Teva Pharms Usa REMS Approved
Clozapine
ANDA #203807
Clozapine Tablet; Oral SUPPL-6 Mayne Pharma REMS Approved
Clozapine
ANDA #206433
Clozapine Tablet; Oral SUPPL-4 Aurobindo Pharma Ltd REMS Approved
Clozaril
NDA #019758
Clozapine Tablet; Oral SUPPL-90 Heritage Life REMS Approved
Fazaclo Odt
NDA #021590
Clozapine Tablet, Orally Disintegrating; Oral SUPPL-31 Jazz Pharms Iii REMS Approved
Isosulfan Blue
ANDA #210714
Isosulfan Blue Injectable; Injection ORIG-1 Beloteca Inc Approved
Lemtrada
BLA #103948
Alemtuzumab Injectable; Injection SUPPL-5163 Genzyme Labeling Approved
Lemtrada
BLA #103948
Alemtuzumab Injectable; Injection SUPPL-5164 Genzyme Labeling Approved
Lemtrada
BLA #103948
Alemtuzumab Injectable; Injection SUPPL-5163 Genzyme Labeling Approved
Lemtrada
BLA #103948
Alemtuzumab Injectable; Injection SUPPL-5164 Genzyme Labeling Approved
Lioresal
NDA #020075
Baclofen Injectable; Intrathecal SUPPL-37 Saol Theraps Res Ltd Labeling Approved
Prasugrel
ANDA #206021
Prasugrel Hydrochloride Tablet; Oral ORIG-1 Hec Pharm Approved
Prevantics Maxi Swabstick
NDA #021524
Chlorhexidine Gluconate; Isopropyl Alcohol Swab; Topical SUPPL-20 Prof Dspls Labeling Approved
Prevantics Swab
NDA #021524
Chlorhexidine Gluconate; Isopropyl Alcohol Swab; Topical SUPPL-20 Prof Dspls Labeling Approved
Prevantics Swabstick
NDA #021524
Chlorhexidine Gluconate; Isopropyl Alcohol Swab; Topical SUPPL-20 Prof Dspls Labeling Approved
Trientine Hydrochloride
ANDA #211251
Trientine Hydrochloride Capsule; Oral ORIG-1 Navinta Llc Approved
Tylenol
NDA #019872
Acetaminophen Tablet, Extended Release; Oral SUPPL-48 J and J Consumer Inc Labeling Approved
Versacloz
NDA #203479
Clozapine Suspension; Oral SUPPL-11 Tasman Pharma REMS Approved
Welchol
NDA #021176
Colesevelam Hydrochloride Tablet; Oral SUPPL-44 Daiichi Sankyo Labeling Approved
Welchol
NDA #022362
Colesevelam Hydrochloride For Suspension; Oral SUPPL-23 Daiichi Sankyo Labeling Approved

January 15, 2019

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Alendronate Sodium
ANDA #076768
Alendronate Sodium Tablet; Oral SUPPL-7 Cipla Labeling Approved
Cytarabine
ANDA #071868
Cytarabine Injectable; Injection SUPPL-31 Hospira Labeling Approved
Cytarabine
ANDA #071868
Cytarabine Injectable; Injection SUPPL-29 Hospira Labeling Approved
Cytarabine
ANDA #071868
Cytarabine Injectable; Injection SUPPL-30 Hospira Labeling Approved
Cytarabine
ANDA #072168
Cytarabine Injectable; Injection SUPPL-29 Hospira Labeling Approved
Cytarabine
ANDA #072168
Cytarabine Injectable; Injection SUPPL-28 Hospira Labeling Approved
Cytarabine
ANDA #072945
Cytarabine Injectable; Injection SUPPL-24 Hospira Labeling Approved
Cytarabine
ANDA #075383
Cytarabine Injectable; Injection SUPPL-17 Hospira Labeling Approved
Dexedrine
NDA #017078
Dextroamphetamine Sulfate Capsule, Extended Release; Oral SUPPL-52 Impax Labs Inc Labeling Approved
Eletriptan Hydrobromide
ANDA #210708
Eletriptan Hydrobromide Tablet; Oral ORIG-1 Aurobindo Pharma Ltd Approved
Hydroxychloroquine Sulfate
ANDA #210959
Hydroxychloroquine Sulfate Tablet; Oral ORIG-1 Rising Pharms Approved
Polocaine
ANDA #088653
Mepivacaine Hydrochloride Injectable; Injection SUPPL-12 Dentsply Pharm Labeling Approved
Polocaine W/ Levonordefrin
ANDA #089517
Levonordefrin; Mepivacaine Hydrochloride Injectable; Injection SUPPL-6 Dentsply Pharm Labeling Approved
Rufinamide
ANDA #207363
Rufinamide Unknown ORIG-1 West-Ward Pharms Int Tentative Approval
Sudafed 12 Hour
ANDA #073585
Pseudoephedrine Hydrochloride Tablet, Extended Release; Oral SUPPL-20 Mcneil Cons Labeling Approved
Trulicity
BLA #125469
Dulaglutide Injectable; Injection SUPPL-23 Eli Lilly and Co Efficacy Approved
Xarelto
NDA #022406
Rivaroxaban Tablet; Oral SUPPL-30 Janssen Pharms Labeling Approved
Xarelto
NDA #022406
Rivaroxaban Tablet; Oral SUPPL-32 Janssen Pharms Labeling Approved
Zegerid Otc
NDA #022281
Omeprazole; Sodium Bicarbonate Capsule; Oral SUPPL-13 Bayer Healthcare Llc Labeling Approved
Zegerid Otc
NDA #022283
Omeprazole; Sodium Bicarbonate For Suspension; Oral SUPPL-3 Bayer Healthcare Llc Labeling Approved
Zegerid Otc
NDA #022283
Omeprazole; Sodium Bicarbonate For Suspension; Oral SUPPL-3 Bayer Healthcare Llc Labeling Approved

January 14, 2019

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Alosetron Hydrochloride
ANDA #209180
Alosetron Hydrochloride Tablet; Oral ORIG-1 Cipla Approved
Busulfan
ANDA #207794
Busulfan Injectable; Injection ORIG-1 Nexus Pharms Approved
Cabometyx
NDA #208692
Cabozantinib S-Malate Tablet; Oral SUPPL-3 Exelixis Inc Efficacy Approved
Hydrochlorothiazide
ANDA #203561
Hydrochlorothiazide Capsule; Oral ORIG-1 Sciegen Pharms Inc Approved
Metformin Hydrochloride
ANDA #075973
Metformin Hydrochloride Tablet; Oral SUPPL-19 Mylan Labeling Approved
Metformin Hydrochloride
ANDA #075973
Metformin Hydrochloride Tablet; Oral SUPPL-20 Mylan Labeling Approved
Metformin Hydrochloride
ANDA #075973
Metformin Hydrochloride Tablet; Oral SUPPL-20 Mylan Labeling Approved
Metformin Hydrochloride
ANDA #209313
Metformin Hydrochloride Tablet, Extended Release; Oral SUPPL-1 Granules India Ltd Labeling Approved
Pioglitazone Hydrochloride
ANDA #078670
Pioglitazone Hydrochloride Tablet; Oral SUPPL-4 Sandoz Labeling Approved
Pioglitazone Hydrochloride
ANDA #078670
Pioglitazone Hydrochloride Tablet; Oral SUPPL-4 Sandoz Labeling Approved
Pioglitazone Hydrochloride
ANDA #078670
Pioglitazone Hydrochloride Tablet; Oral SUPPL-5 Sandoz Labeling Approved
Vigabatrin
ANDA #209822
Vigabatrin Tablet; Oral ORIG-1 Teva Pharms Usa Approved

January 11, 2019

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Acyclovir
ANDA #209971
Acyclovir Ointment; Topical ORIG-1 Torrent Pharms Ltd Approved
Amlodipine Besylate and Atorvastatin Calcium
ANDA #207762
Amlodipine Besylate; Atorvastatin Calcium Tablet; Oral ORIG-1 Zydus Pharms Usa Inc Approved
Betamethasone Dipropionate
ANDA #208885
Betamethasone Dipropionate Cream; Topical ORIG-1 Zydus Pharms Usa Inc Approved
Celexa
NDA #020822
Citalopram Hydrobromide Tablet; Oral SUPPL-51 Allergan Sales Llc Labeling Approved
Clobetasol Propionate
ANDA #211401
Clobetasol Propionate Cream; Topical ORIG-1 Solaris Pharma Corp Approved
Gilenya
NDA #022527
Fingolimod Hydrochloride Capsule; Oral SUPPL-26 Novartis Labeling Approved
Humira
BLA #125057
Adalimumab Syringe SUPPL-411 Abbvie Inc Labeling Approved
Humira
BLA #125057
Adalimumab Vial SUPPL-411 Abbvie Inc Labeling Approved
Letrozole
ANDA #211717
Letrozole Tablet; Oral ORIG-1 Eugia Pharma Approved
Lexapro
NDA #021323
Escitalopram Oxalate Tablet; Oral SUPPL-51 Allergan Sales Llc Labeling Approved
Lexapro
NDA #021365
Escitalopram Oxalate Solution; Oral SUPPL-36 Allergan Sales Llc Labeling Approved
Lisinopril
ANDA #075994
Lisinopril Tablet; Oral SUPPL-53 Casi Pharms Inc Labeling Approved
Lisinopril
ANDA #075994
Lisinopril Tablet; Oral SUPPL-56 Casi Pharms Inc Labeling Approved
Mycophenolate Mofetil
ANDA #203005
Mycophenolate Mofetil Suspension; Oral SUPPL-4 Alkem Labs Ltd Labeling Approved
Mycophenolate Mofetil
ANDA #203005
Mycophenolate Mofetil Suspension; Oral SUPPL-6 Alkem Labs Ltd Labeling Approved
Mycophenolate Mofetil
ANDA #203005
Mycophenolate Mofetil Suspension; Oral SUPPL-7 Alkem Labs Ltd Labeling Approved
Mycophenolate Mofetil
ANDA #203005
Mycophenolate Mofetil Suspension; Oral SUPPL-6 Alkem Labs Ltd Labeling Approved
Nalbuphine Hydrochloride
ANDA #207595
Nalbuphine Hydrochloride Injectable; Injection ORIG-1 Mylan Labs Ltd Approved
Potassium Chloride 0.15% In Sodium Chloride 0.45% In Plastic Container
NDA #017648
Potassium Chloride; Sodium Chloride Injectable; Injection SUPPL-71 Baxter Hlthcare Labeling Approved
Potassium Chloride 0.15% In Sodium Chloride 0.9% In Plastic Container
NDA #017648
Potassium Chloride; Sodium Chloride Injectable; Injection SUPPL-71 Baxter Hlthcare Labeling Approved
Potassium Chloride 0.224% In Sodium Chloride 0.9%
NDA #017648
Potassium Chloride; Sodium Chloride Injectable; Injection SUPPL-71 Baxter Hlthcare Labeling Approved
Potassium Chloride 0.3% and Sodium Chloride 0.9% In Plastic Container
NDA #017648
Potassium Chloride; Sodium Chloride Injectable; Injection SUPPL-71 Baxter Hlthcare Labeling Approved
Sodium Chloride 0.9% and Potassium Chloride 0.075% In Plastic Container
NDA #017648
Potassium Chloride; Sodium Chloride Injectable; Injection SUPPL-71 Baxter Hlthcare Labeling Approved
Xyzal
NDA #022064
Levocetirizine Dihydrochloride Tablet; Oral SUPPL-37 Sanofi Aventis Us Labeling Approved
Xyzal
NDA #022157
Levocetirizine Dihydrochloride Solution; Oral SUPPL-19 Sanofi Aventis Us Labeling Approved

January 10, 2019

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Fluoxetine Hydrochloride
ANDA #211282
Fluoxetine Hydrochloride Tablet; Oral ORIG-1 Sciegen Pharms Inc Approved
Focalin
NDA #021278
Dexmethylphenidate Hydrochloride Tablet; Oral SUPPL-11 Novartis Labeling Approved
Focalin
NDA #021278
Dexmethylphenidate Hydrochloride Tablet; Oral SUPPL-19 Novartis Labeling Approved
Focalin Xr
NDA #021802
Dexmethylphenidate Hydrochloride Capsule, Extended Release; Oral SUPPL-19 Novartis Labeling Approved
Focalin Xr
NDA #021802
Dexmethylphenidate Hydrochloride Capsule, Extended Release; Oral SUPPL-29 Novartis Labeling Approved
Ingrezza
NDA #209241
Valbenazine Tosylate Capsule; Oral SUPPL-6 Neurocrine Manufacturing (CMC) Approved
Olmesartan Medoxomil
ANDA #210552
Olmesartan Medoxomil Tablet; Oral ORIG-1 Qilu Pharm Co Ltd Approved
Olopatadine Hydrochloride
ANDA #209015
Olopatadine Hydrochloride Unknown SUPPL-1 Apotex Inc Tentative Approval
Ritalin
NDA #010187
Methylphenidate Hydrochloride Tablet; Oral SUPPL-71 Novartis Labeling Approved
Ritalin
NDA #010187
Methylphenidate Hydrochloride Tablet; Oral SUPPL-82 Novartis Labeling Approved
Ritalin La
NDA #021284
Methylphenidate Hydrochloride Capsule, Extended Release; Oral SUPPL-16 Novartis Labeling Approved
Ritalin La
NDA #021284
Methylphenidate Hydrochloride Capsule, Extended Release; Oral SUPPL-29 Novartis Labeling Approved
Ritalin-Sr
NDA #018029
Methylphenidate Hydrochloride Tablet, Extended Release; Oral SUPPL-41 Novartis Labeling Approved
Ritalin-Sr
NDA #018029
Methylphenidate Hydrochloride Tablet, Extended Release; Oral SUPPL-51 Novartis Labeling Approved

January 9, 2019

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Cinqair
BLA #761033
Reslizumab Injectable; Injection SUPPL-10 Teva Respiratory Llc Labeling Approved
Ingenol Mebutate
ANDA #209019
Ingenol Mebutate Gel; Topical ORIG-1 Perrigo Uk Finco Approved
Levocetirizine Dihydrochloride
ANDA #090199
Levocetirizine Dihydrochloride Tablet; Oral SUPPL-12 Teva Pharms Labeling Approved
Levocetirizine Dihydrochloride
ANDA #090199
Levocetirizine Dihydrochloride Tablet; Oral SUPPL-13 Teva Pharms Labeling Approved
Mannitol 10%
NDA #016269
Mannitol Injectable; Injection SUPPL-55 Hospira Labeling Approved
Mannitol 10% In Plastic Container
NDA #019603
Mannitol Injectable; Injection SUPPL-38 Icu Medical Inc Labeling Approved
Mannitol 10% In Plastic Container
NDA #019603
Mannitol Injectable; Injection SUPPL-38 Icu Medical Inc Labeling Approved
Mannitol 10% In Plastic Container
NDA #020006
Mannitol Injectable; Injection SUPPL-25 B Braun Labeling Approved
Mannitol 15%
NDA #016269
Mannitol Injectable; Injection SUPPL-55 Hospira Labeling Approved
Mannitol 15% In Plastic Container
NDA #019603
Mannitol Injectable; Injection SUPPL-38 Icu Medical Inc Labeling Approved
Mannitol 15% In Plastic Container
NDA #019603
Mannitol Injectable; Injection SUPPL-38 Icu Medical Inc Labeling Approved
Mannitol 15% In Plastic Container
NDA #020006
Mannitol Injectable; Injection SUPPL-25 B Braun Labeling Approved
Mannitol 20%
NDA #016269
Mannitol Injectable; Injection SUPPL-55 Hospira Labeling Approved
Mannitol 20% In Plastic Container
NDA #019603
Mannitol Injectable; Injection SUPPL-38 Icu Medical Inc Labeling Approved
Mannitol 20% In Plastic Container
NDA #019603
Mannitol Injectable; Injection SUPPL-38 Icu Medical Inc Labeling Approved
Mannitol 20% In Plastic Container
NDA #020006
Mannitol Injectable; Injection SUPPL-25 B Braun Labeling Approved
Mannitol 25%
NDA #016269
Mannitol Injectable; Injection SUPPL-55 Hospira Labeling Approved
Mannitol 5%
NDA #016269
Mannitol Injectable; Injection SUPPL-55 Hospira Labeling Approved
Mannitol 5% In Plastic Container
NDA #019603
Mannitol Injectable; Injection SUPPL-38 Icu Medical Inc Labeling Approved
Mannitol 5% In Plastic Container
NDA #019603
Mannitol Injectable; Injection SUPPL-38 Icu Medical Inc Labeling Approved
Mannitol 5% In Plastic Container
NDA #020006
Mannitol Injectable; Injection SUPPL-25 B Braun Labeling Approved
Methylprednisolone
ANDA #210985
Methylprednisolone Tablet; Oral ORIG-1 Riconpharma Llc Approved
Natrecor
NDA #020920
Nesiritide Recombinant For Solution; Intravenous SUPPL-36 Scios Llc Labeling Approved
Olopatadine Hydrochloride
ANDA #209015
Olopatadine Hydrochloride Unknown ORIG-1 Apotex Inc Tentative Approval
Pregabalin
ANDA #209357
Pregabalin Unknown ORIG-1 Msn Laboratories Tentative Approval
Proair Digihaler
NDA #205636
Albuterol Sulfate Powder; Inhalation SUPPL-12 Teva Branded Pharm Labeling Approved
Proair Respiclick
NDA #205636
Albuterol Sulfate Powder, Metered; Inhalation SUPPL-12 Teva Branded Pharm Labeling Approved
Vimpat
NDA #022253
Lacosamide Tablet; Oral SUPPL-41 Ucb Inc Efficacy Approved
Vimpat
NDA #022254
Lacosamide Solution; Intravenous SUPPL-32 Ucb Inc Efficacy Approved
Vimpat
NDA #022255
Lacosamide Solution; Oral SUPPL-23 Ucb Inc Efficacy Approved

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