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.

April 23, 2018

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Absorica
NDA #021951
Isotretinoin Capsule; Oral SUPPL-12 Sun Pharm Inds Inc REMS Approved
Amnesteem
ANDA #075945
Isotretinoin Capsule; Oral SUPPL-36 Mylan Pharms Inc REMS Approved
Claravis
ANDA #076135
Isotretinoin Capsule; Oral SUPPL-42 Teva Pharms Usa REMS Approved
Claravis
ANDA #076356
Isotretinoin Capsule; Oral SUPPL-39 Teva Pharms Usa REMS Approved
Isotretinoin
ANDA #207792
Isotretinoin Capsule; Oral SUPPL-3 Amneal Pharms Ny REMS Approved
Myorisan
ANDA #076485
Isotretinoin Capsule; Oral SUPPL-19 Douglas Pharms REMS Approved
Zenatane
ANDA #202099
Isotretinoin Capsule; Oral SUPPL-12 Dr Reddys Labs Ltd REMS Approved

April 20, 2018

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Amlodipine Besylate
ANDA #077073
Amlodipine Besylate Tablet; Oral SUPPL-15 Cipla Ltd Labeling Approved
Amlodipine Besylate
ANDA #077073
Amlodipine Besylate Tablet; Oral SUPPL-15 Cipla Ltd Labeling Approved
Amlodipine Besylate
ANDA #077073
Amlodipine Besylate Tablet; Oral SUPPL-16 Cipla Ltd Labeling Approved
Amlodipine Besylate
ANDA #077073
Amlodipine Besylate Tablet; Oral SUPPL-15 Cipla Ltd Labeling Approved
Amlodipine Besylate
ANDA #077073
Amlodipine Besylate Tablet; Oral SUPPL-16 Cipla Ltd Labeling Approved
Amlodipine Besylate
ANDA #077955
Amlodipine Besylate Tablet; Oral SUPPL-14 Invagen Pharms Labeling Approved
Bleomycin Sulfate
ANDA #205030
Bleomycin Sulfate Injectable; Injection ORIG-1 Hong Kong Approved
Fenofibrate
ANDA #076509
Fenofibrate Tablet; Oral SUPPL-26 Impax Labs Labeling Approved
Ferriprox
NDA #208030
Deferiprone Solution; Oral SUPPL-2 Apopharma Inc Efficacy Approved
Micafungin
ANDA #208366
Micafungin Injectable; Injection ORIG-1 Apotex Inc Tentative Approval
Palonosetron Hydrochloride
ANDA #205870
Palonosetron Hydrochloride Injectable; Intravenous ORIG-1 Sagent Pharms Tentative Approval
Tafinlar
NDA #202806
Dabrafenib Mesylate Capsule; Oral SUPPL-9 Novartis Pharms Corp Labeling Approved
Tetrabenazine
ANDA #210544
Tetrabenazine Tablet; Oral ORIG-1 Lupin Ltd Approved

April 19, 2018

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Acitretin
ANDA #091455
Acitretin Capsule; Oral SUPPL-10 Barr Labs Inc Labeling Approved
Acitretin
ANDA #202552
Acitretin Capsule; Oral SUPPL-4 Impax Labs Inc Labeling Approved
Acitretin
ANDA #202897
Acitretin Capsule; Oral SUPPL-10 Teva Pharms Usa Labeling Approved
Acitretin
ANDA #202897
Acitretin Capsule; Oral SUPPL-10 Teva Pharms Usa Labeling Approved
Acitretin
ANDA #204633
Acitretin Capsule; Oral SUPPL-4 Sigmapharm Labs Llc Labeling Approved
Acitretin
ANDA #204633
Acitretin Capsule; Oral SUPPL-4 Sigmapharm Labs Llc Labeling Approved
Akynzeo
NDA #210493
Fosnetupitant;Palonosetron Hydrochloride Injectable; Injection ORIG-1 Helsinn Hlthcare Type 1 - New Molecular Entity Approved
Clarinex D 24 Hour
NDA #021605
Desloratadine; Pseudoephedrine Sulfate Tablet, Extended Release; Oral SUPPL-13 Merck Sharp Dohme Labeling Approved
Clarinex-D 12 Hour
NDA #021313
Desloratadine; Pseudoephedrine Sulfate Tablet, Extended Release; Oral SUPPL-10 Merck Sharp Dohme Labeling Approved
Dexamethasone Sodium Phosphate Preservative Free
ANDA #207442
Dexamethasone Sodium Phosphate Injectable; Injection ORIG-1 Somerset Theraps Llc Approved
Hibistat
NDA #018300
Chlorhexidine Gluconate Solution; Topical SUPPL-19 Molnlycke Hlth Labeling Approved
Levulan
NDA #020965
Aminolevulinic Acid Hydrochloride Solution; Topical SUPPL-16 Dusa Labeling Approved
Soolantra
NDA #206255
Ivermectin Cream; Topical SUPPL-4 Galderma Labs Lp Labeling Approved
Taltz
BLA #125521
Ixekizumab Injectable; Injection SUPPL-2 Eli Lilly and Co Approved
Unasyn
NDA #050608
Ampicillin Sodium; Sulbactam Sodium Injectable; Injection SUPPL-46 Pfizer Labeling Approved

April 18, 2018

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Advil Pm
NDA #021394
Diphenhydramine Citrate; Ibuprofen Tablet; Oral SUPPL-25 Pfizer Labeling Approved
Aripiprazole
ANDA #207240
Aripiprazole Tablet, Orally Disintegrating; Oral ORIG-1 Sciegen Pharms Inc Approved
Asacol Hd
NDA #021830
Mesalamine Tablet, Delayed Release; Oral SUPPL-12 Apil Labeling Approved
Claritin
NDA #021952
Loratadine Capsule; Oral SUPPL-14 Bayer Healthcare Llc Labeling Approved
Clobetasol Propionate
ANDA #210190
Clobetasol Propionate Solution; Topical ORIG-1 Glenmark Pharms Ltd Approved
Econazole Nitrate
ANDA #210364
Econazole Nitrate Cream; Topical ORIG-1 Mylan Pharms Inc Approved
Evotaz
NDA #206353
Atazanavir Sulfate; Cobicistat Tablet; Oral SUPPL-5 Bristol-Myers Squibb Labeling Approved
Glucagen
NDA #020918
Glucagon Hydrochloride Recombinant Injectable; Injection SUPPL-49 Novo Nordisk Labeling Approved
Glucagen
NDA #020918
Glucagon Hydrochloride Recombinant Injectable; Injection SUPPL-49 Novo Nordisk Labeling Approved
Glucagen
NDA #020918
Glucagon Hydrochloride Recombinant Injectable; Injection SUPPL-49 Novo Nordisk Labeling Approved
Glucagon
NDA #020928
Glucagon Recombinant Injectable; Injection SUPPL-55 Lilly Labeling Approved
Glucagon
NDA #020928
Glucagon Recombinant Injectable; Injection SUPPL-55 Lilly Labeling Approved
Glucagon
NDA #020928
Glucagon Recombinant Injectable; Injection SUPPL-55 Lilly Labeling Approved
Lidocaine Hydrochloride
ANDA #208017
Lidocaine Hydrochloride Injectable; Injection ORIG-1 Spectra Mdcl Devices Approved
Lupron Depot
NDA #020708
Leuprolide Acetate Injectable; Injection SUPPL-35 Abbvie Endocrine Inc Labeling Approved
Reyataz
NDA #021567
Atazanavir Sulfate Capsule; Oral SUPPL-42 Bristol Myers Squibb Labeling Approved
Reyataz
NDA #206352
Atazanavir Sulfate Powder; Oral SUPPL-7 Bristol Myers Squibb Labeling Approved
Tagrisso
NDA #208065
Osimertinib Mesylate Tablet; Oral SUPPL-8 Astrazeneca Pharms Efficacy Approved
Tagrisso
NDA #208065
Osimertinib Mesylate Tablet; Oral SUPPL-9 Astrazeneca Pharms Labeling Approved
Treprostinil
ANDA #203649
Treprostinil Injectable; Iv (Infusion), Subcutaneous SUPPL-1 Sandoz Inc Manufacturing (CMC) Approved
Tysabri
BLA #125104
Natalizumab Vial; Single-Use SUPPL-963 Biogen Idec Labeling Approved
Tysabri
BLA #125104
Natalizumab Vial; Single-Use SUPPL-960 Biogen Idec Labeling Approved
Tysabri
BLA #125104
Natalizumab Vial; Single-Use SUPPL-960 Biogen Idec Labeling Approved
Tysabri
BLA #125104
Natalizumab Vial; Single-Use SUPPL-963 Biogen Idec Labeling Approved

April 17, 2018

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Alimta
NDA #021462
Pemetrexed Disodium Injectable; Iv (Infusion) SUPPL-52 Lilly Labeling Approved
Capecitabine
ANDA #210604
Capecitabine Tablet; Oral ORIG-1 Eugia Pharma Approved
Carnitor
NDA #018948
Levocarnitine Solution; Oral SUPPL-28 Leadiant Biosci Inc Labeling Approved
Carnitor
NDA #018948
Levocarnitine Tablet; Oral SUPPL-28 Leadiant Biosci Inc Labeling Approved
Carnitor
NDA #019257
Levocarnitine Solution; Oral SUPPL-14 Leadiant Biosci Inc Labeling Approved
Carnitor
NDA #020182
Levocarnitine Injectable; Injection SUPPL-15 Leadiant Biosci Inc Labeling Approved
Carnitor Sf
NDA #019257
Levocarnitine Solution; Oral SUPPL-14 Leadiant Biosci Inc Labeling Approved
Clobetasol Propionate
ANDA #209701
Clobetasol Propionate Ointment; Topical ORIG-1 Chemo Research Sl Approved
Clobetasol Propionate
ANDA #209974
Clobetasol Propionate Cream; Topical ORIG-1 Teligent Pharma Inc Approved
Clobetasol Propionate
ANDA #210446
Clobetasol Propionate Spray; Topical ORIG-1 Apotex Inc Approved
Crysvita
BLA #761068
Burosumab-Twza Injectable; Injection ORIG-1 Ultragenyx Pharm Inc Type 1 - New Molecular Entity Approved
Diclofenac Sodium
ANDA #206411
Diclofenac Sodium Solution; Topical ORIG-1 Zydus Pharms Usa Inc Approved
Doxazosin Mesylate
ANDA #209013
Doxazosin Mesylate Tablet; Oral ORIG-1 Appco Pharma Llc Approved
Evoclin
NDA #050801
Clindamycin Phosphate Aerosol, Foam; Topical SUPPL-18 Mylan Pharms Inc Labeling Approved
Ibuprofen
ANDA #209179
Ibuprofen Suspension; Oral ORIG-1 Aurobindo Pharma Ltd Approved
Irbesartan
ANDA #204740
Irbesartan Tablet; Oral ORIG-1 Amneal Pharms Approved
Levocetirizine Dihydrochloride
ANDA #210375
Levocetirizine Dihydrochloride Tablet; Oral SUPPL-2 Dr Reddys Labs Ltd Manufacturing (CMC) Approved
Methocarbamol
ANDA #209331
Methocarbamol Solution; Im-Iv ORIG-1 Fresenius Kabi Usa Approved
Miglustat
ANDA #208342
Miglustat Capsule; Oral ORIG-1 Amerigen Pharms Ltd Approved
Morphine Sulfate
ANDA #205509
Morphine Sulfate Solution; Oral ORIG-1 Ani Pharms Inc Approved
Omnipaque 140
NDA #018956
Iohexol Injectable; Injection SUPPL-101 Ge Healthcare Labeling Approved
Omnipaque 140
NDA #018956
Iohexol Injectable; Injection SUPPL-101 Ge Healthcare Labeling Approved
Omnipaque 180
NDA #018956
Iohexol Solution; Injection, Oral, Rectal SUPPL-101 Ge Healthcare Labeling Approved
Omnipaque 180
NDA #018956
Iohexol Solution; Injection, Oral, Rectal SUPPL-101 Ge Healthcare Labeling Approved
Omnipaque 210
NDA #018956
Iohexol Injectable; Injection SUPPL-101 Ge Healthcare Labeling Approved
Omnipaque 210
NDA #018956
Iohexol Injectable; Injection SUPPL-101 Ge Healthcare Labeling Approved
Omnipaque 240
NDA #018956
Iohexol Solution; Injection, Oral, Rectal SUPPL-101 Ge Healthcare Labeling Approved
Omnipaque 240
NDA #018956
Iohexol Solution; Injection, Oral, Rectal SUPPL-101 Ge Healthcare Labeling Approved
Omnipaque 300
NDA #018956
Iohexol Solution; Injection, Oral, Rectal SUPPL-101 Ge Healthcare Labeling Approved
Omnipaque 300
NDA #018956
Iohexol Solution; Injection, Oral, Rectal SUPPL-101 Ge Healthcare Labeling Approved
Omnipaque 350
NDA #018956
Iohexol Solution; Injection, Oral SUPPL-101 Ge Healthcare Labeling Approved
Omnipaque 350
NDA #018956
Iohexol Solution; Injection, Oral SUPPL-101 Ge Healthcare Labeling Approved
Omnipaque 70
NDA #018956
Iohexol Solution; Urethral SUPPL-101 Ge Healthcare Labeling Approved
Omnipaque 70
NDA #018956
Iohexol Solution; Urethral SUPPL-101 Ge Healthcare Labeling Approved
Pioglitazone Hydrochloride
ANDA #207806
Pioglitazone Hydrochloride Tablet; Oral ORIG-1 Prinston Inc Approved
Silodosin
ANDA #209745
Silodosin Unknown ORIG-1 Amneal Pharms Co Tentative Approval
Sodium Nitroprusside
ANDA #210763
Sodium Nitroprusside Injectable; Injection ORIG-1 Mylan Labs Ltd Approved
Tavalisse
NDA #209299
Fostamatinib Tablet; Oral ORIG-1 Rigel Pharms Inc Type 1 - New Molecular Entity Approved
Tranylcypromine Sulfate
ANDA #206856
Tranylcypromine Sulfate Tablet; Oral ORIG-1 Kinedexe Uk Approved

April 16, 2018

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Adenosine
ANDA #205568
Adenosine Injectable; Injection ORIG-1 Fresenius Kabi Usa Approved
Cleocin Phosphate
NDA #050441
Clindamycin Phosphate Injectable; Injection SUPPL-79 Pharmacia and Upjohn Labeling Approved
Cleocin Phosphate In Dextrose 5% In Plastic Container
NDA #050639
Clindamycin Phosphate Injectable; Injection SUPPL-38 Pharmacia and Upjohn Labeling Approved
Clindamycin Phosphate
ANDA #090108
Clindamycin Phosphate Injectable; Injection SUPPL-5 Sagent Pharms Labeling Approved
Clindamycin Phosphate
ANDA #090108
Clindamycin Phosphate Injectable; Injection SUPPL-6 Sagent Pharms Labeling Approved
Clindamycin Phosphate
ANDA #090108
Clindamycin Phosphate Injectable; Injection SUPPL-9 Sagent Pharms Labeling Approved
Clindamycin Phosphate
ANDA #090108
Clindamycin Phosphate Injectable; Injection SUPPL-10 Sagent Pharms Labeling Approved
Clindamycin Phosphate
ANDA #090109
Clindamycin Phosphate Injectable; Injection SUPPL-7 Sagent Pharms Labeling Approved
Clindamycin Phosphate
ANDA #090109
Clindamycin Phosphate Injectable; Injection SUPPL-8 Sagent Pharms Labeling Approved
Clindamycin Phosphate
ANDA #090109
Clindamycin Phosphate Injectable; Injection SUPPL-11 Sagent Pharms Labeling Approved
Clindamycin Phosphate
ANDA #090109
Clindamycin Phosphate Injectable; Injection SUPPL-12 Sagent Pharms Labeling Approved
Ertapenem Sodium
ANDA #208790
Ertapenem Sodium Injectable; Intramuscular, Iv (Infusion) ORIG-1 Acs Dobfar Spa Approved
Loratadine
ANDA #208314
Loratadine Tablet; Oral ORIG-1 Aurobindo Pharma Ltd Approved
Loratadine
ANDA #210088
Loratadine Tablet, Chewable; Oral ORIG-1 Sun Pharma Global Approved
Opdivo
BLA #125554
Nivolumab Injectable; Injection SUPPL-58 Bristol Myers Squibb Efficacy Approved
Tacrolimus
ANDA #210393
Tacrolimus Ointment; Topical ORIG-1 Glenmark Pharms Ltd Approved
Tazorac
NDA #020600
Tazarotene Gel; Topical SUPPL-10 Allergan Labeling Approved
Tygacil
NDA #021821
Tigecycline Powder; Iv (Infusion) SUPPL-45 Pf Prism Cv Labeling Approved
Yervoy
BLA #125377
Ipilimumab Injectable; Injection SUPPL-94 Bristol Myers Squibb Efficacy Approved

April 23, 2018

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Absorica
NDA #021951
Isotretinoin Capsule; Oral SUPPL-12 Sun Pharm Inds Inc REMS Approved
Amnesteem
ANDA #075945
Isotretinoin Capsule; Oral SUPPL-36 Mylan Pharms Inc REMS Approved
Claravis
ANDA #076135
Isotretinoin Capsule; Oral SUPPL-42 Teva Pharms Usa REMS Approved
Claravis
ANDA #076356
Isotretinoin Capsule; Oral SUPPL-39 Teva Pharms Usa REMS Approved
Isotretinoin
ANDA #207792
Isotretinoin Capsule; Oral SUPPL-3 Amneal Pharms Ny REMS Approved
Myorisan
ANDA #076485
Isotretinoin Capsule; Oral SUPPL-19 Douglas Pharms REMS Approved
Zenatane
ANDA #202099
Isotretinoin Capsule; Oral SUPPL-12 Dr Reddys Labs Ltd REMS Approved

April 20, 2018

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Amlodipine Besylate
ANDA #077073
Amlodipine Besylate Tablet; Oral SUPPL-15 Cipla Ltd Labeling Approved
Amlodipine Besylate
ANDA #077073
Amlodipine Besylate Tablet; Oral SUPPL-15 Cipla Ltd Labeling Approved
Amlodipine Besylate
ANDA #077073
Amlodipine Besylate Tablet; Oral SUPPL-16 Cipla Ltd Labeling Approved
Amlodipine Besylate
ANDA #077073
Amlodipine Besylate Tablet; Oral SUPPL-15 Cipla Ltd Labeling Approved
Amlodipine Besylate
ANDA #077073
Amlodipine Besylate Tablet; Oral SUPPL-16 Cipla Ltd Labeling Approved
Amlodipine Besylate
ANDA #077955
Amlodipine Besylate Tablet; Oral SUPPL-14 Invagen Pharms Labeling Approved
Bleomycin Sulfate
ANDA #205030
Bleomycin Sulfate Injectable; Injection ORIG-1 Hong Kong Approved
Fenofibrate
ANDA #076509
Fenofibrate Tablet; Oral SUPPL-26 Impax Labs Labeling Approved
Ferriprox
NDA #208030
Deferiprone Solution; Oral SUPPL-2 Apopharma Inc Efficacy Approved
Micafungin
ANDA #208366
Micafungin Injectable; Injection ORIG-1 Apotex Inc Tentative Approval
Palonosetron Hydrochloride
ANDA #205870
Palonosetron Hydrochloride Injectable; Intravenous ORIG-1 Sagent Pharms Tentative Approval
Tafinlar
NDA #202806
Dabrafenib Mesylate Capsule; Oral SUPPL-9 Novartis Pharms Corp Labeling Approved
Tetrabenazine
ANDA #210544
Tetrabenazine Tablet; Oral ORIG-1 Lupin Ltd Approved

April 19, 2018

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Acitretin
ANDA #091455
Acitretin Capsule; Oral SUPPL-10 Barr Labs Inc Labeling Approved
Acitretin
ANDA #202552
Acitretin Capsule; Oral SUPPL-4 Impax Labs Inc Labeling Approved
Acitretin
ANDA #202897
Acitretin Capsule; Oral SUPPL-10 Teva Pharms Usa Labeling Approved
Acitretin
ANDA #202897
Acitretin Capsule; Oral SUPPL-10 Teva Pharms Usa Labeling Approved
Acitretin
ANDA #204633
Acitretin Capsule; Oral SUPPL-4 Sigmapharm Labs Llc Labeling Approved
Acitretin
ANDA #204633
Acitretin Capsule; Oral SUPPL-4 Sigmapharm Labs Llc Labeling Approved
Akynzeo
NDA #210493
Fosnetupitant;Palonosetron Hydrochloride Injectable; Injection ORIG-1 Helsinn Hlthcare Type 1 - New Molecular Entity Approved
Clarinex D 24 Hour
NDA #021605
Desloratadine; Pseudoephedrine Sulfate Tablet, Extended Release; Oral SUPPL-13 Merck Sharp Dohme Labeling Approved
Clarinex-D 12 Hour
NDA #021313
Desloratadine; Pseudoephedrine Sulfate Tablet, Extended Release; Oral SUPPL-10 Merck Sharp Dohme Labeling Approved
Dexamethasone Sodium Phosphate Preservative Free
ANDA #207442
Dexamethasone Sodium Phosphate Injectable; Injection ORIG-1 Somerset Theraps Llc Approved
Hibistat
NDA #018300
Chlorhexidine Gluconate Solution; Topical SUPPL-19 Molnlycke Hlth Labeling Approved
Levulan
NDA #020965
Aminolevulinic Acid Hydrochloride Solution; Topical SUPPL-16 Dusa Labeling Approved
Soolantra
NDA #206255
Ivermectin Cream; Topical SUPPL-4 Galderma Labs Lp Labeling Approved
Taltz
BLA #125521
Ixekizumab Injectable; Injection SUPPL-2 Eli Lilly and Co Approved
Unasyn
NDA #050608
Ampicillin Sodium; Sulbactam Sodium Injectable; Injection SUPPL-46 Pfizer Labeling Approved

April 18, 2018

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Advil Pm
NDA #021394
Diphenhydramine Citrate; Ibuprofen Tablet; Oral SUPPL-25 Pfizer Labeling Approved
Aripiprazole
ANDA #207240
Aripiprazole Tablet, Orally Disintegrating; Oral ORIG-1 Sciegen Pharms Inc Approved
Asacol Hd
NDA #021830
Mesalamine Tablet, Delayed Release; Oral SUPPL-12 Apil Labeling Approved
Claritin
NDA #021952
Loratadine Capsule; Oral SUPPL-14 Bayer Healthcare Llc Labeling Approved
Clobetasol Propionate
ANDA #210190
Clobetasol Propionate Solution; Topical ORIG-1 Glenmark Pharms Ltd Approved
Econazole Nitrate
ANDA #210364
Econazole Nitrate Cream; Topical ORIG-1 Mylan Pharms Inc Approved
Evotaz
NDA #206353
Atazanavir Sulfate; Cobicistat Tablet; Oral SUPPL-5 Bristol-Myers Squibb Labeling Approved
Glucagen
NDA #020918
Glucagon Hydrochloride Recombinant Injectable; Injection SUPPL-49 Novo Nordisk Labeling Approved
Glucagen
NDA #020918
Glucagon Hydrochloride Recombinant Injectable; Injection SUPPL-49 Novo Nordisk Labeling Approved
Glucagen
NDA #020918
Glucagon Hydrochloride Recombinant Injectable; Injection SUPPL-49 Novo Nordisk Labeling Approved
Glucagon
NDA #020928
Glucagon Recombinant Injectable; Injection SUPPL-55 Lilly Labeling Approved
Glucagon
NDA #020928
Glucagon Recombinant Injectable; Injection SUPPL-55 Lilly Labeling Approved
Glucagon
NDA #020928
Glucagon Recombinant Injectable; Injection SUPPL-55 Lilly Labeling Approved
Lidocaine Hydrochloride
ANDA #208017
Lidocaine Hydrochloride Injectable; Injection ORIG-1 Spectra Mdcl Devices Approved
Lupron Depot
NDA #020708
Leuprolide Acetate Injectable; Injection SUPPL-35 Abbvie Endocrine Inc Labeling Approved
Reyataz
NDA #021567
Atazanavir Sulfate Capsule; Oral SUPPL-42 Bristol Myers Squibb Labeling Approved
Reyataz
NDA #206352
Atazanavir Sulfate Powder; Oral SUPPL-7 Bristol Myers Squibb Labeling Approved
Tagrisso
NDA #208065
Osimertinib Mesylate Tablet; Oral SUPPL-8 Astrazeneca Pharms Efficacy Approved
Tagrisso
NDA #208065
Osimertinib Mesylate Tablet; Oral SUPPL-9 Astrazeneca Pharms Labeling Approved
Treprostinil
ANDA #203649
Treprostinil Injectable; Iv (Infusion), Subcutaneous SUPPL-1 Sandoz Inc Manufacturing (CMC) Approved
Tysabri
BLA #125104
Natalizumab Vial; Single-Use SUPPL-963 Biogen Idec Labeling Approved
Tysabri
BLA #125104
Natalizumab Vial; Single-Use SUPPL-960 Biogen Idec Labeling Approved
Tysabri
BLA #125104
Natalizumab Vial; Single-Use SUPPL-960 Biogen Idec Labeling Approved
Tysabri
BLA #125104
Natalizumab Vial; Single-Use SUPPL-963 Biogen Idec Labeling Approved

April 17, 2018

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Alimta
NDA #021462
Pemetrexed Disodium Injectable; Iv (Infusion) SUPPL-52 Lilly Labeling Approved
Capecitabine
ANDA #210604
Capecitabine Tablet; Oral ORIG-1 Eugia Pharma Approved
Carnitor
NDA #018948
Levocarnitine Solution; Oral SUPPL-28 Leadiant Biosci Inc Labeling Approved
Carnitor
NDA #018948
Levocarnitine Tablet; Oral SUPPL-28 Leadiant Biosci Inc Labeling Approved
Carnitor
NDA #019257
Levocarnitine Solution; Oral SUPPL-14 Leadiant Biosci Inc Labeling Approved
Carnitor
NDA #020182
Levocarnitine Injectable; Injection SUPPL-15 Leadiant Biosci Inc Labeling Approved
Carnitor Sf
NDA #019257
Levocarnitine Solution; Oral SUPPL-14 Leadiant Biosci Inc Labeling Approved
Clobetasol Propionate
ANDA #209701
Clobetasol Propionate Ointment; Topical ORIG-1 Chemo Research Sl Approved
Clobetasol Propionate
ANDA #209974
Clobetasol Propionate Cream; Topical ORIG-1 Teligent Pharma Inc Approved
Clobetasol Propionate
ANDA #210446
Clobetasol Propionate Spray; Topical ORIG-1 Apotex Inc Approved
Crysvita
BLA #761068
Burosumab-Twza Injectable; Injection ORIG-1 Ultragenyx Pharm Inc Type 1 - New Molecular Entity Approved
Diclofenac Sodium
ANDA #206411
Diclofenac Sodium Solution; Topical ORIG-1 Zydus Pharms Usa Inc Approved
Doxazosin Mesylate
ANDA #209013
Doxazosin Mesylate Tablet; Oral ORIG-1 Appco Pharma Llc Approved
Evoclin
NDA #050801
Clindamycin Phosphate Aerosol, Foam; Topical SUPPL-18 Mylan Pharms Inc Labeling Approved
Ibuprofen
ANDA #209179
Ibuprofen Suspension; Oral ORIG-1 Aurobindo Pharma Ltd Approved
Irbesartan
ANDA #204740
Irbesartan Tablet; Oral ORIG-1 Amneal Pharms Approved
Levocetirizine Dihydrochloride
ANDA #210375
Levocetirizine Dihydrochloride Tablet; Oral SUPPL-2 Dr Reddys Labs Ltd Manufacturing (CMC) Approved
Methocarbamol
ANDA #209331
Methocarbamol Solution; Im-Iv ORIG-1 Fresenius Kabi Usa Approved
Miglustat
ANDA #208342
Miglustat Capsule; Oral ORIG-1 Amerigen Pharms Ltd Approved
Morphine Sulfate
ANDA #205509
Morphine Sulfate Solution; Oral ORIG-1 Ani Pharms Inc Approved
Omnipaque 140
NDA #018956
Iohexol Injectable; Injection SUPPL-101 Ge Healthcare Labeling Approved
Omnipaque 140
NDA #018956
Iohexol Injectable; Injection SUPPL-101 Ge Healthcare Labeling Approved
Omnipaque 180
NDA #018956
Iohexol Solution; Injection, Oral, Rectal SUPPL-101 Ge Healthcare Labeling Approved
Omnipaque 180
NDA #018956
Iohexol Solution; Injection, Oral, Rectal SUPPL-101 Ge Healthcare Labeling Approved
Omnipaque 210
NDA #018956
Iohexol Injectable; Injection SUPPL-101 Ge Healthcare Labeling Approved
Omnipaque 210
NDA #018956
Iohexol Injectable; Injection SUPPL-101 Ge Healthcare Labeling Approved
Omnipaque 240
NDA #018956
Iohexol Solution; Injection, Oral, Rectal SUPPL-101 Ge Healthcare Labeling Approved
Omnipaque 240
NDA #018956
Iohexol Solution; Injection, Oral, Rectal SUPPL-101 Ge Healthcare Labeling Approved
Omnipaque 300
NDA #018956
Iohexol Solution; Injection, Oral, Rectal SUPPL-101 Ge Healthcare Labeling Approved
Omnipaque 300
NDA #018956
Iohexol Solution; Injection, Oral, Rectal SUPPL-101 Ge Healthcare Labeling Approved
Omnipaque 350
NDA #018956
Iohexol Solution; Injection, Oral SUPPL-101 Ge Healthcare Labeling Approved
Omnipaque 350
NDA #018956
Iohexol Solution; Injection, Oral SUPPL-101 Ge Healthcare Labeling Approved
Omnipaque 70
NDA #018956
Iohexol Solution; Urethral SUPPL-101 Ge Healthcare Labeling Approved
Omnipaque 70
NDA #018956
Iohexol Solution; Urethral SUPPL-101 Ge Healthcare Labeling Approved
Pioglitazone Hydrochloride
ANDA #207806
Pioglitazone Hydrochloride Tablet; Oral ORIG-1 Prinston Inc Approved
Silodosin
ANDA #209745
Silodosin Unknown ORIG-1 Amneal Pharms Co Tentative Approval
Sodium Nitroprusside
ANDA #210763
Sodium Nitroprusside Injectable; Injection ORIG-1 Mylan Labs Ltd Approved
Tavalisse
NDA #209299
Fostamatinib Tablet; Oral ORIG-1 Rigel Pharms Inc Type 1 - New Molecular Entity Approved
Tranylcypromine Sulfate
ANDA #206856
Tranylcypromine Sulfate Tablet; Oral ORIG-1 Kinedexe Uk Approved

April 16, 2018

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Adenosine
ANDA #205568
Adenosine Injectable; Injection ORIG-1 Fresenius Kabi Usa Approved
Cleocin Phosphate
NDA #050441
Clindamycin Phosphate Injectable; Injection SUPPL-79 Pharmacia and Upjohn Labeling Approved
Cleocin Phosphate In Dextrose 5% In Plastic Container
NDA #050639
Clindamycin Phosphate Injectable; Injection SUPPL-38 Pharmacia and Upjohn Labeling Approved
Clindamycin Phosphate
ANDA #090108
Clindamycin Phosphate Injectable; Injection SUPPL-5 Sagent Pharms Labeling Approved
Clindamycin Phosphate
ANDA #090108
Clindamycin Phosphate Injectable; Injection SUPPL-6 Sagent Pharms Labeling Approved
Clindamycin Phosphate
ANDA #090108
Clindamycin Phosphate Injectable; Injection SUPPL-9 Sagent Pharms Labeling Approved
Clindamycin Phosphate
ANDA #090108
Clindamycin Phosphate Injectable; Injection SUPPL-10 Sagent Pharms Labeling Approved
Clindamycin Phosphate
ANDA #090109
Clindamycin Phosphate Injectable; Injection SUPPL-7 Sagent Pharms Labeling Approved
Clindamycin Phosphate
ANDA #090109
Clindamycin Phosphate Injectable; Injection SUPPL-8 Sagent Pharms Labeling Approved
Clindamycin Phosphate
ANDA #090109
Clindamycin Phosphate Injectable; Injection SUPPL-11 Sagent Pharms Labeling Approved
Clindamycin Phosphate
ANDA #090109
Clindamycin Phosphate Injectable; Injection SUPPL-12 Sagent Pharms Labeling Approved
Ertapenem Sodium
ANDA #208790
Ertapenem Sodium Injectable; Intramuscular, Iv (Infusion) ORIG-1 Acs Dobfar Spa Approved
Loratadine
ANDA #208314
Loratadine Tablet; Oral ORIG-1 Aurobindo Pharma Ltd Approved
Loratadine
ANDA #210088
Loratadine Tablet, Chewable; Oral ORIG-1 Sun Pharma Global Approved
Opdivo
BLA #125554
Nivolumab Injectable; Injection SUPPL-58 Bristol Myers Squibb Efficacy Approved
Tacrolimus
ANDA #210393
Tacrolimus Ointment; Topical ORIG-1 Glenmark Pharms Ltd Approved
Tazorac
NDA #020600
Tazarotene Gel; Topical SUPPL-10 Allergan Labeling Approved
Tygacil
NDA #021821
Tigecycline Powder; Iv (Infusion) SUPPL-45 Pf Prism Cv Labeling Approved
Yervoy
BLA #125377
Ipilimumab Injectable; Injection SUPPL-94 Bristol Myers Squibb Efficacy Approved

April 13, 2018

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Antivert
NDA #010721
Meclizine Hydrochloride Tablet, Chewable; Oral SUPPL-61 Casper Pharma Llc Efficacy Approved
Antivert
NDA #010721
Meclizine Hydrochloride Tablet; Oral SUPPL-61 Casper Pharma Llc Efficacy Approved
Definity
NDA #021064
Perflutren Injectable; Intravenous SUPPL-21 Lantheus Medcl Manufacturing (CMC) Approved
Kevzara
BLA #761037
Sarilumab Injectable; Injection SUPPL-1 Sanofi Synthelabo Efficacy Approved
Nulojix
BLA #125288
Belatacept Injectable; Injection SUPPL-75 Bristol Myers Squibb Efficacy Approved
Pravastatin Sodium
ANDA #209869
Pravastatin Sodium Tablet; Oral ORIG-1 Appco Pharma Llc Approved
Prevacid
NDA #020406
Lansoprazole Capsule, Delayed Rel Pellets; Oral SUPPL-84 Takeda Pharms Usa Labeling Approved
Prevacid
NDA #021428
Lansoprazole Tablet, Orally Disintegrating, Delayed Release; Oral SUPPL-32 Takeda Pharms Usa Labeling Approved
Testosterone
ANDA #208560
Testosterone Gel; Topical ORIG-1 Lupin Atlantis Tentative Approval
Varubi
NDA #206500
Rolapitant Hydrochloride Tablet; Oral SUPPL-3 Tesaro Inc Labeling Approved
Varubi
NDA #208399
Rolapitant Hydrochloride Emulsion; Iv (Infusion) SUPPL-2 Tesaro Inc Labeling Approved
Viberzi
NDA #206940
Eluxadoline Tablet; Oral SUPPL-3 Allergan Holdings Labeling Approved
Viberzi
NDA #206940
Eluxadoline Tablet; Oral SUPPL-3 Allergan Holdings Labeling Approved

April 12, 2018

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Advil
NDA #201803
Ibuprofen Sodium Tablet; Oral SUPPL-11 Pfizer Cons Hlthcare Labeling Approved
Everolimus
ANDA #206133
Everolimus Tablet; Oral ORIG-1 West-Ward Pharms Int Approved
Netspot
NDA #208547
Gallium Dotatate Ga-68 Powder; Intravenous SUPPL-11 Aaa Usa Inc Labeling Approved
Praxbind
BLA #761025
Idarucizumab Injectable; Injection SUPPL-2 Boehringer Ingelheim Efficacy Approved
Syndros
NDA #205525
Dronabinol Solution; Oral SUPPL-5 Insys Dev Co Inc Labeling Approved

April 11, 2018

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Candesartan Cilexetil and Hydrochlorothiazide
ANDA #207455
Candesartan Cilexetil; Hydrochlorothiazide Tablet; Oral ORIG-1 Prinston Inc Approved
Cyproheptadine Hydrochloride
ANDA #209172
Cyproheptadine Hydrochloride Tablet; Oral ORIG-1 Strides Pharma Approved
Daptomycin
ANDA #206077
Daptomycin Powder; Intravenous ORIG-1 Fresenius Kabi Usa Approved
Docetaxel
NDA #203551
Docetaxel Injectable; Injection SUPPL-5 Actavis Llc Labeling Approved
Docetaxel
NDA #203551
Docetaxel Injectable; Injection SUPPL-5 Actavis Llc Labeling Approved
Dopamine Hydrochloride
ANDA #207707
Dopamine Hydrochloride Injectable; Injection ORIG-1 Hikma Intl Pharms Approved
Flac
ANDA #210736
Fluocinolone Acetonide Oil/Drops; Otic ORIG-1 Patrin Pharma Inc Approved
Ibuprofen
ANDA #079174
Ibuprofen Tablet; Oral SUPPL-14 Granules India Labeling Approved
Ibuprofen
ANDA #079174
Ibuprofen Tablet; Oral SUPPL-10 Granules India Manufacturing (CMC) Approved
Ibuprofen
ANDA #079174
Ibuprofen Tablet; Oral SUPPL-14 Granules India Labeling Approved
Ibuprofen
ANDA #079174
Ibuprofen Tablet; Oral SUPPL-10 Granules India Manufacturing (CMC) Approved
Loratadine
ANDA #208477
Loratadine Tablet, Orally Disintegrating; Oral ORIG-1 Aurobindo Pharma Ltd Approved
Metro I.V. In Plastic Container
NDA #018900
Metronidazole Injectable; Injection SUPPL-35 B Braun Labeling Approved
Semprex-D
NDA #019806
Acrivastine; Pseudoephedrine Hydrochloride Capsule; Oral SUPPL-13 Auxilium Pharms Llc Labeling Approved

April 10, 2018

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Afinitor
NDA #022334
Everolimus Tablet; Oral SUPPL-40 Novartis Efficacy Approved
Afinitor Disperz
NDA #203985
Everolimus Tablet, For Suspension; Oral SUPPL-13 Novartis Pharm Efficacy Approved
Blincyto
BLA #125557
Blinatumomab Injectable; Injection SUPPL-14 Amgen Manufacturing (CMC) Approved
Celestone Soluspan
NDA #014602
Betamethasone Acetate; Betamethasone Sodium Phosphate Injectable; Injection SUPPL-62 Merck Sharp Dohme Labeling Approved
Dofetilide
ANDA #208625
Dofetilide Capsule; Oral ORIG-1 Apicore Us Approved
Dupixent
BLA #761055
Dupilumab Injectable; Injection SUPPL-3 Regeneron Pharmaceuticals Efficacy Approved
Lamivudine and Zidovudine
ANDA #206375
Lamivudine; Zidovudine Tablet; Oral ORIG-1 Shanghai Desano Approved
Metformin Hydrochloride; Sitagliptin Phosphate
ANDA #205078
Metformin Hydrochloride;Sitagliptin Phosphate Unknown ORIG-1 Sun Pharma Global Tentative Approval

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