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.

March 15, 2019

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Albuterol Sulfate
ANDA #210948
Albuterol Sulfate Tablet; Oral ORIG-1 Aizant Approved
Aptiom
NDA #022416
Eslicarbazepine Acetate Tablet; Oral SUPPL-11 Sunovion Pharms Inc Efficacy Approved
Clarinex
NDA #021165
Desloratadine Tablet; Oral SUPPL-22 Merck Sharp Dohme Labeling Approved
Clarinex
NDA #021300
Desloratadine Solution; Oral SUPPL-19 Merck Sharp Dohme Labeling Approved
Clarinex
NDA #021312
Desloratadine Tablet, Orally Disintegrating; Oral SUPPL-20 Merck Sharp Dohme Labeling Approved
Clarinex
NDA #021563
Desloratadine Syrup; Oral SUPPL-8 Schering Labeling Approved
Clarinex D 24 Hour
NDA #021605
Desloratadine; Pseudoephedrine Sulfate Tablet, Extended Release; Oral SUPPL-17 Merck Sharp Dohme Labeling Approved
Clarinex-D 12 Hour
NDA #021313
Desloratadine; Pseudoephedrine Sulfate Tablet, Extended Release; Oral SUPPL-12 Merck Sharp Dohme Labeling Approved
Dificid
NDA #201699
Fidaxomicin Tablet; Oral SUPPL-10 Cubist Pharms Llc Labeling Approved
Efavirenz; Lamivudine; Tenofovir Disoproxil Fumarate
NDA #210649
Efavirenz;Lamivudine;Tenofovir Disoproxil Fumarate Tablet; Oral ORIG-1 Macleods Pharms Ltd Type 5 - New Formulation or New Manufacturer Approved
Valsartan and Hydrochlorothiazide
ANDA #203000
Hydrochlorothiazide; Valsartan Tablet; Oral ORIG-1 Zydus Pharms Usa Inc Approved

March 14, 2019

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Avycaz
NDA #206494
Avibactam Sodium; Ceftazidime Powder; Iv (Infusion) SUPPL-5 Allergan Sales Llc Efficacy Approved
Avycaz
NDA #206494
Avibactam Sodium; Ceftazidime Powder; Iv (Infusion) SUPPL-6 Allergan Sales Llc Efficacy Approved
Clindamycin Phosphate and Benzoyl Peroxide
ANDA #209252
Benzoyl Peroxide; Clindamycin Phosphate Gel; Topical ORIG-1 Glenmark Pharms Approved
Enoxaparin Sodium
ANDA #208600
Enoxaparin Sodium Injectable; Intravenous, Subcutaneous ORIG-1 Amphastar Pharms Inc Approved
Eptifibatide
ANDA #204361
Eptifibatide Injectable; Injection ORIG-1 Usv Approved
Helidac
NDA #050719
Bismuth Subsalicylate; Metronidazole; Tetracycline Hydrochloride Tablet, Chewable, Tablet, Capsule; Oral SUPPL-22 Casper Pharma Llc Labeling Approved

March 13, 2019

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Children's Cetirizine Hydrochloride Allergy
ANDA #210622
Cetirizine Hydrochloride Syrup; Oral ORIG-1 Hetero Labs Ltd Iii Approved
Docetaxel
ANDA #209634
Docetaxel Injectable; Injection SUPPL-2 Cipla Labeling Approved
Fenoglide
NDA #022118
Fenofibrate Tablet; Oral SUPPL-9 Santarus Inc Labeling Approved
Metformin Hydrochloride;Sitagliptin Phosphate
ANDA #209573
Metformin Hydrochloride;Sitagliptin Phosphate Unknown ORIG-1 Zydus Pharms Usa Inc Tentative Approval
Nordette-28
NDA #018782
Ethinyl Estradiol; Levonorgestrel Tablet; Oral-28 SUPPL-39 Teva Branded Pharm Labeling Approved
Sodium Chloride 3% In Plastic Container
ANDA #209476
Sodium Chloride Injectable; Injection ORIG-1 Fresenius Kabi Usa Approved
Solifenacin Succinate
ANDA #211423
Solifenacin Succinate Unknown ORIG-1 Cspc Ouyi Pharm Co Tentative Approval

March 12, 2019

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Allopurinol
ANDA #211820
Allopurinol Tablet; Oral ORIG-1 Unichem Labs Ltd Approved
Apriso
NDA #022301
Mesalamine Capsule, Extended Release; Oral SUPPL-14 Valeant Pharms Intl Labeling Approved
Bidil
NDA #020727
Hydralazine Hydrochloride; Isosorbide Dinitrate Tablet; Oral SUPPL-10 Arbor Pharms Llc Labeling Approved
Desonide
ANDA #212002
Desonide Ointment; Topical ORIG-1 Teligent Pharma Inc Approved
Loratadine
ANDA #207569
Loratadine Tablet; Oral ORIG-1 Newgen Pharms Llc Approved
Nifedipine
ANDA #210614
Nifedipine Tablet, Extended Release; Oral ORIG-1 Novast Labs Approved
Rocklatan
NDA #208259
Netarsudil;Latanoprost Solution; Ophthalmic ORIG-1 Aerie Pharms Inc Approved
Tetracaine Hydrochloride
NDA #210821
Tetracaine Hydrochloride Solution; Ophthalmic ORIG-1 Bausch Health Ireland Limited Type 5 - New Formulation or New Manufacturer Approved
Tizanidine Hydrochloride
ANDA #210267
Tizanidine Hydrochloride Capsule; Oral ORIG-1 Riconpharma Llc Approved
Valsartan
ANDA #205536
Valsartan Tablet; Oral ORIG-1 Alkem Labs Ltd Approved
Visipaque 270
NDA #020351
Iodixanol Injectable; Injection SUPPL-48 Ge Healthcare Labeling Approved
Visipaque 270
NDA #020808
Iodixanol Injectable; Injection SUPPL-28 Ge Healthcare Labeling Approved
Visipaque 320
NDA #020351
Iodixanol Injectable; Injection SUPPL-48 Ge Healthcare Labeling Approved
Visipaque 320
NDA #020808
Iodixanol Injectable; Injection SUPPL-28 Ge Healthcare Labeling Approved

March 11, 2019

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Aimovig
BLA #761077
Erenumab-Aooe Injectable; Injection SUPPL-1 Amgen Inc Efficacy Approved
Bleomycin Sulfate
ANDA #209439
Bleomycin Sulfate Injectable; Injection ORIG-1 Cipla Approved
Brimonidine Tartrate
ANDA #208992
Brimonidine Tartrate Solution/Drops; Ophthalmic ORIG-1 Somerset Theraps Llc Approved
Dalfampridine
ANDA #210158
Dalfampridine Tablet, Extended Release; Oral ORIG-1 Micro Labs Approved
Dupixent
BLA #761055
Dupilumab Injectable; Injection SUPPL-12 Regeneron Pharmaceuticals Efficacy Approved
Enzalutamide
ANDA #209614
Enzalutamide Unknown ORIG-1 Actavis Labs Fl Inc Tentative Approval
Eptifibatide
ANDA #204362
Eptifibatide Injectable; Injection ORIG-1 Usv Approved
Faslodex
NDA #021344
Fulvestrant Injectable; Intramuscular SUPPL-37 Astrazeneca Efficacy Approved
Nikki
ANDA #201661
Drospirenone; Ethinyl Estradiol Tablet; Oral SUPPL-1 Lupin Ltd Labeling Approved
Nikki
ANDA #201661
Drospirenone; Ethinyl Estradiol Tablet; Oral SUPPL-4 Lupin Ltd Labeling Approved
Nikki
ANDA #201661
Drospirenone; Ethinyl Estradiol Tablet; Oral SUPPL-6 Lupin Ltd Manufacturing (CMC) Approved
Nikki
ANDA #201661
Drospirenone; Ethinyl Estradiol Tablet; Oral SUPPL-4 Lupin Ltd Labeling Approved
Noxafil
NDA #022003
Posaconazole Suspension; Oral SUPPL-24 Schering Labeling Approved
Noxafil
NDA #205053
Posaconazole Tablet, Delayed Release; Oral SUPPL-8 Merck Sharp Dohme Labeling Approved
Noxafil
NDA #205596
Posaconazole Solution; Intravenous SUPPL-7 Merck Sharp Dohme Labeling Approved
Potassium Chloride
ANDA #208445
Potassium Chloride Capsule, Extended Release; Oral ORIG-1 Zydus Pharms Usa Inc Approved
Prochlorperazine Edisylate
ANDA #040540
Prochlorperazine Edisylate Injectable; Injection SUPPL-16 Athenex Inc Manufacturing (CMC) Approved
Trazimera
BLA #761081
Trastuzumab-Qyyp Injectable; Injection ORIG-1 Pfizer Inc Approved

March 10, 2019

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Aspirin and Dipyridamole
ANDA #206753
Aspirin; Dipyridamole Capsule, Extended Release; Oral SUPPL-2 Zydus Pharms Usa Inc Labeling Approved
Aspirin and Dipyridamole
ANDA #206753
Aspirin; Dipyridamole Capsule, Extended Release; Oral SUPPL-2 Zydus Pharms Usa Inc Labeling Approved
Aspirin and Dipyridamole
ANDA #209048
Aspirin; Dipyridamole Capsule, Extended Release; Oral SUPPL-1 Dr Reddys Labs Ltd Labeling Approved
Aspirin and Dipyridamole
ANDA #209048
Aspirin; Dipyridamole Capsule, Extended Release; Oral SUPPL-1 Dr Reddys Labs Ltd Labeling Approved
Entecavir
ANDA #206217
Entecavir Tablet; Oral SUPPL-5 Aurobindo Pharma Ltd Labeling Approved
Entecavir
ANDA #206217
Entecavir Tablet; Oral SUPPL-2 Aurobindo Pharma Ltd Labeling Approved
Entecavir
ANDA #206217
Entecavir Tablet; Oral SUPPL-5 Aurobindo Pharma Ltd Labeling Approved
Entecavir
ANDA #206217
Entecavir Tablet; Oral SUPPL-6 Aurobindo Pharma Ltd Labeling Approved
Entecavir
ANDA #206217
Entecavir Tablet; Oral SUPPL-7 Aurobindo Pharma Ltd Labeling Approved
Torsemide
ANDA #076110
Torsemide Tablet; Oral SUPPL-6 Teva Labeling Approved

March 15, 2019

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Albuterol Sulfate
ANDA #210948
Albuterol Sulfate Tablet; Oral ORIG-1 Aizant Approved
Aptiom
NDA #022416
Eslicarbazepine Acetate Tablet; Oral SUPPL-11 Sunovion Pharms Inc Efficacy Approved
Clarinex
NDA #021165
Desloratadine Tablet; Oral SUPPL-22 Merck Sharp Dohme Labeling Approved
Clarinex
NDA #021300
Desloratadine Solution; Oral SUPPL-19 Merck Sharp Dohme Labeling Approved
Clarinex
NDA #021312
Desloratadine Tablet, Orally Disintegrating; Oral SUPPL-20 Merck Sharp Dohme Labeling Approved
Clarinex
NDA #021563
Desloratadine Syrup; Oral SUPPL-8 Schering Labeling Approved
Clarinex D 24 Hour
NDA #021605
Desloratadine; Pseudoephedrine Sulfate Tablet, Extended Release; Oral SUPPL-17 Merck Sharp Dohme Labeling Approved
Clarinex-D 12 Hour
NDA #021313
Desloratadine; Pseudoephedrine Sulfate Tablet, Extended Release; Oral SUPPL-12 Merck Sharp Dohme Labeling Approved
Dificid
NDA #201699
Fidaxomicin Tablet; Oral SUPPL-10 Cubist Pharms Llc Labeling Approved
Efavirenz; Lamivudine; Tenofovir Disoproxil Fumarate
NDA #210649
Efavirenz;Lamivudine;Tenofovir Disoproxil Fumarate Tablet; Oral ORIG-1 Macleods Pharms Ltd Type 5 - New Formulation or New Manufacturer Approved
Valsartan and Hydrochlorothiazide
ANDA #203000
Hydrochlorothiazide; Valsartan Tablet; Oral ORIG-1 Zydus Pharms Usa Inc Approved

March 14, 2019

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Avycaz
NDA #206494
Avibactam Sodium; Ceftazidime Powder; Iv (Infusion) SUPPL-5 Allergan Sales Llc Efficacy Approved
Avycaz
NDA #206494
Avibactam Sodium; Ceftazidime Powder; Iv (Infusion) SUPPL-6 Allergan Sales Llc Efficacy Approved
Clindamycin Phosphate and Benzoyl Peroxide
ANDA #209252
Benzoyl Peroxide; Clindamycin Phosphate Gel; Topical ORIG-1 Glenmark Pharms Approved
Enoxaparin Sodium
ANDA #208600
Enoxaparin Sodium Injectable; Intravenous, Subcutaneous ORIG-1 Amphastar Pharms Inc Approved
Eptifibatide
ANDA #204361
Eptifibatide Injectable; Injection ORIG-1 Usv Approved
Helidac
NDA #050719
Bismuth Subsalicylate; Metronidazole; Tetracycline Hydrochloride Tablet, Chewable, Tablet, Capsule; Oral SUPPL-22 Casper Pharma Llc Labeling Approved

March 13, 2019

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Children's Cetirizine Hydrochloride Allergy
ANDA #210622
Cetirizine Hydrochloride Syrup; Oral ORIG-1 Hetero Labs Ltd Iii Approved
Docetaxel
ANDA #209634
Docetaxel Injectable; Injection SUPPL-2 Cipla Labeling Approved
Fenoglide
NDA #022118
Fenofibrate Tablet; Oral SUPPL-9 Santarus Inc Labeling Approved
Metformin Hydrochloride;Sitagliptin Phosphate
ANDA #209573
Metformin Hydrochloride;Sitagliptin Phosphate Unknown ORIG-1 Zydus Pharms Usa Inc Tentative Approval
Nordette-28
NDA #018782
Ethinyl Estradiol; Levonorgestrel Tablet; Oral-28 SUPPL-39 Teva Branded Pharm Labeling Approved
Sodium Chloride 3% In Plastic Container
ANDA #209476
Sodium Chloride Injectable; Injection ORIG-1 Fresenius Kabi Usa Approved
Solifenacin Succinate
ANDA #211423
Solifenacin Succinate Unknown ORIG-1 Cspc Ouyi Pharm Co Tentative Approval

March 12, 2019

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Allopurinol
ANDA #211820
Allopurinol Tablet; Oral ORIG-1 Unichem Labs Ltd Approved
Apriso
NDA #022301
Mesalamine Capsule, Extended Release; Oral SUPPL-14 Valeant Pharms Intl Labeling Approved
Bidil
NDA #020727
Hydralazine Hydrochloride; Isosorbide Dinitrate Tablet; Oral SUPPL-10 Arbor Pharms Llc Labeling Approved
Desonide
ANDA #212002
Desonide Ointment; Topical ORIG-1 Teligent Pharma Inc Approved
Loratadine
ANDA #207569
Loratadine Tablet; Oral ORIG-1 Newgen Pharms Llc Approved
Nifedipine
ANDA #210614
Nifedipine Tablet, Extended Release; Oral ORIG-1 Novast Labs Approved
Rocklatan
NDA #208259
Netarsudil;Latanoprost Solution; Ophthalmic ORIG-1 Aerie Pharms Inc Approved
Tetracaine Hydrochloride
NDA #210821
Tetracaine Hydrochloride Solution; Ophthalmic ORIG-1 Bausch Health Ireland Limited Type 5 - New Formulation or New Manufacturer Approved
Tizanidine Hydrochloride
ANDA #210267
Tizanidine Hydrochloride Capsule; Oral ORIG-1 Riconpharma Llc Approved
Valsartan
ANDA #205536
Valsartan Tablet; Oral ORIG-1 Alkem Labs Ltd Approved
Visipaque 270
NDA #020351
Iodixanol Injectable; Injection SUPPL-48 Ge Healthcare Labeling Approved
Visipaque 270
NDA #020808
Iodixanol Injectable; Injection SUPPL-28 Ge Healthcare Labeling Approved
Visipaque 320
NDA #020351
Iodixanol Injectable; Injection SUPPL-48 Ge Healthcare Labeling Approved
Visipaque 320
NDA #020808
Iodixanol Injectable; Injection SUPPL-28 Ge Healthcare Labeling Approved

March 11, 2019

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Aimovig
BLA #761077
Erenumab-Aooe Injectable; Injection SUPPL-1 Amgen Inc Efficacy Approved
Bleomycin Sulfate
ANDA #209439
Bleomycin Sulfate Injectable; Injection ORIG-1 Cipla Approved
Brimonidine Tartrate
ANDA #208992
Brimonidine Tartrate Solution/Drops; Ophthalmic ORIG-1 Somerset Theraps Llc Approved
Dalfampridine
ANDA #210158
Dalfampridine Tablet, Extended Release; Oral ORIG-1 Micro Labs Approved
Dupixent
BLA #761055
Dupilumab Injectable; Injection SUPPL-12 Regeneron Pharmaceuticals Efficacy Approved
Enzalutamide
ANDA #209614
Enzalutamide Unknown ORIG-1 Actavis Labs Fl Inc Tentative Approval
Eptifibatide
ANDA #204362
Eptifibatide Injectable; Injection ORIG-1 Usv Approved
Faslodex
NDA #021344
Fulvestrant Injectable; Intramuscular SUPPL-37 Astrazeneca Efficacy Approved
Nikki
ANDA #201661
Drospirenone; Ethinyl Estradiol Tablet; Oral SUPPL-1 Lupin Ltd Labeling Approved
Nikki
ANDA #201661
Drospirenone; Ethinyl Estradiol Tablet; Oral SUPPL-4 Lupin Ltd Labeling Approved
Nikki
ANDA #201661
Drospirenone; Ethinyl Estradiol Tablet; Oral SUPPL-6 Lupin Ltd Manufacturing (CMC) Approved
Nikki
ANDA #201661
Drospirenone; Ethinyl Estradiol Tablet; Oral SUPPL-4 Lupin Ltd Labeling Approved
Noxafil
NDA #022003
Posaconazole Suspension; Oral SUPPL-24 Schering Labeling Approved
Noxafil
NDA #205053
Posaconazole Tablet, Delayed Release; Oral SUPPL-8 Merck Sharp Dohme Labeling Approved
Noxafil
NDA #205596
Posaconazole Solution; Intravenous SUPPL-7 Merck Sharp Dohme Labeling Approved
Potassium Chloride
ANDA #208445
Potassium Chloride Capsule, Extended Release; Oral ORIG-1 Zydus Pharms Usa Inc Approved
Prochlorperazine Edisylate
ANDA #040540
Prochlorperazine Edisylate Injectable; Injection SUPPL-16 Athenex Inc Manufacturing (CMC) Approved
Trazimera
BLA #761081
Trastuzumab-Qyyp Injectable; Injection ORIG-1 Pfizer Inc Approved

March 10, 2019

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Aspirin and Dipyridamole
ANDA #206753
Aspirin; Dipyridamole Capsule, Extended Release; Oral SUPPL-2 Zydus Pharms Usa Inc Labeling Approved
Aspirin and Dipyridamole
ANDA #206753
Aspirin; Dipyridamole Capsule, Extended Release; Oral SUPPL-2 Zydus Pharms Usa Inc Labeling Approved
Aspirin and Dipyridamole
ANDA #209048
Aspirin; Dipyridamole Capsule, Extended Release; Oral SUPPL-1 Dr Reddys Labs Ltd Labeling Approved
Aspirin and Dipyridamole
ANDA #209048
Aspirin; Dipyridamole Capsule, Extended Release; Oral SUPPL-1 Dr Reddys Labs Ltd Labeling Approved
Entecavir
ANDA #206217
Entecavir Tablet; Oral SUPPL-5 Aurobindo Pharma Ltd Labeling Approved
Entecavir
ANDA #206217
Entecavir Tablet; Oral SUPPL-2 Aurobindo Pharma Ltd Labeling Approved
Entecavir
ANDA #206217
Entecavir Tablet; Oral SUPPL-5 Aurobindo Pharma Ltd Labeling Approved
Entecavir
ANDA #206217
Entecavir Tablet; Oral SUPPL-6 Aurobindo Pharma Ltd Labeling Approved
Entecavir
ANDA #206217
Entecavir Tablet; Oral SUPPL-7 Aurobindo Pharma Ltd Labeling Approved
Torsemide
ANDA #076110
Torsemide Tablet; Oral SUPPL-6 Teva Labeling Approved

March 8, 2019

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Atenolol and Chlorthalidone
ANDA #210028
Atenolol; Chlorthalidone Tablet; Oral ORIG-1 Zydus Pharms Usa Inc Approved
Folic Acid
ANDA #211064
Folic Acid Tablet; Oral ORIG-1 Invatech Pharma Approved
Haldol
NDA #015923
Haloperidol Lactate Injectable; Injection SUPPL-95 Janssen Pharms Labeling Approved
Haldol
NDA #018701
Haloperidol Decanoate Injectable; Injection SUPPL-73 Janssen Pharms Labeling Approved
Hydrocodone Bitartrate and Acetaminophen
ANDA #211023
Acetaminophen; Hydrocodone Bitartrate Solution; Oral ORIG-1 Wes Pharma Inc Approved
Parsabiv
NDA #208325
Etelcalcetide Solution; Intravenous SUPPL-2 Kai Pharms Inc Labeling Approved
Pyridostigmine Bromide
ANDA #211694
Pyridostigmine Bromide Syrup; Oral ORIG-1 Novitium Pharma Approved
Sporanox
NDA #020083
Itraconazole Capsule; Oral SUPPL-63 Janssen Pharms Labeling Approved
Sporanox
NDA #020657
Itraconazole Solution; Oral SUPPL-37 Janssen Pharms Labeling Approved
Tecentriq
BLA #761034
Atezolizumab Injectable; Injection SUPPL-18 Genentech Inc Efficacy Approved
Tofacitinib
ANDA #209790
Tofacitinib Unknown ORIG-1 Sun Pharm Inds Ltd Tentative Approval

March 7, 2019

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Abacavir; Dolutegravir; Lamivudine
ANDA #210899
Abacavir;Dolutegravir;Lamivudine Unknown ORIG-1 Laurus Labs Ltd Tentative Approval
Imodium A-D
NDA #019860
Loperamide Hydrochloride Tablet; Oral SUPPL-33 J and J Consumer Inc Labeling Approved
Opdivo
BLA #125554
Nivolumab Injectable; Injection SUPPL-42 Bristol Myers Squibb Efficacy Approved

March 6, 2019

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Atorvastatin Calcium
ANDA #204991
Atorvastatin Calcium Tablet; Oral ORIG-1 Lupin Ltd Approved
Bumetanide
ANDA #202900
Bumetanide Tablet; Oral SUPPL-1 Zydus Pharms Usa Inc Labeling Approved
Calcitriol
ANDA #211030
Calcitriol Unknown ORIG-1 Gland Pharma Ltd Tentative Approval
Carvedilol
ANDA #078251
Carvedilol Tablet; Oral SUPPL-18 Glenmark Generics Labeling Approved
Pioglitazone Hydrochloride and Metformin Hydrochloride
ANDA #204802
Metformin Hydrochloride; Pioglitazone Hydrochloride Tablet; Oral SUPPL-5 Macleods Pharms Ltd Labeling Approved
Pioglitazone Hydrochloride and Metformin Hydrochloride
ANDA #204802
Metformin Hydrochloride; Pioglitazone Hydrochloride Tablet; Oral SUPPL-8 Macleods Pharms Ltd Labeling Approved
Pioglitazone Hydrochloride and Metformin Hydrochloride
ANDA #204802
Metformin Hydrochloride; Pioglitazone Hydrochloride Tablet; Oral SUPPL-5 Macleods Pharms Ltd Labeling Approved
Pioglitazone Hydrochloride and Metformin Hydrochloride
ANDA #204802
Metformin Hydrochloride; Pioglitazone Hydrochloride Tablet; Oral SUPPL-8 Macleods Pharms Ltd Labeling Approved
Simvastatin
ANDA #078034
Simvastatin Tablet; Oral SUPPL-12 Biocon Limited Labeling Approved
Sivextro
NDA #205435
Tedizolid Phosphate Tablet; Oral SUPPL-10 Cubist Pharms Llc Efficacy Approved
Sivextro
NDA #205436
Tedizolid Phosphate Powder; Intravenous SUPPL-5 Cubist Pharms Llc Efficacy Approved
Solifenacin Succinate
ANDA #211657
Solifenacin Succinate Unknown ORIG-1 Sciegen Pharms Inc Tentative Approval
Tranexamic Acid
ANDA #201885
Tranexamic Acid Injectable; Injection SUPPL-6 Luitpold Labeling Approved

March 5, 2019

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Bepotastine Besilate
ANDA #206066
Bepotastine Besilate Solution/Drops; Ophthalmic ORIG-1 Apotex Inc Approved
Clonidine Hydrochloride
ANDA #209675
Clonidine Hydrochloride Tablet, Extended Release; Oral ORIG-1 Novast Labs Approved
Esomeprazole Magnesium
ANDA #209202
Esomeprazole Magnesium Tablet, Delayed Release; Oral ORIG-1 Actavis Elizabeth Approved
Prevymis
NDA #209939
Letermovir Tablet; Oral SUPPL-3 Merck Sharp Dohme Labeling Approved
Prevymis
NDA #209940
Letermovir Solution; Intravenous SUPPL-1 Merck Sharp Dohme Labeling Approved
Spravato
NDA #211243
Esketamine Spray; Nasal ORIG-1 Janssen Pharms Type 2 - New Active Ingredient Approved
Zykadia
NDA #205755
Ceritinib Capsule; Oral SUPPL-16 Novartis Pharms Corp Labeling Approved

March 4, 2019

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Aliskiren Hemifumarate; Hydrochlorothiazide
ANDA #205769
Aliskiren Hemifumarate;Hydrochlorothiazide Unknown ORIG-1 Par Pharm Inc Tentative Approval
Clobetasol Propionate
ANDA #211800
Clobetasol Propionate Ointment; Topical ORIG-1 Aleor Dermaceuticals Approved
Desvenlafaxine Succinate
ANDA #204003
Desvenlafaxine Succinate Tablet, Extended Release; Oral SUPPL-6 Alembic Pharms Ltd Labeling Approved
Fulvestrant
ANDA #210044
Fulvestrant Injectable; Intramuscular ORIG-1 Amneal Pharms Co Approved
Lupron Depot
NDA #019732
Leuprolide Acetate Injectable; Injection SUPPL-44 Abbvie Endocrine Inc Labeling Approved
Lupron Depot
NDA #020517
Leuprolide Acetate Injectable; Injection SUPPL-42 Abbvie Endocrine Inc Labeling Approved
Nuplazid
NDA #207318
Pimavanserin Tartrate Tablet; Oral SUPPL-6 Acadia Pharms Inc Labeling Approved
Nuplazid
NDA #210793
Pimavanserin Tartrate Capsule; Oral SUPPL-1 Acadia Pharms Inc Labeling Approved
Rivastigmine
ANDA #206318
Rivastigmine Film, Extended Release; Transdermal ORIG-1 Zydus Noveltech Inc Approved
Telmisartan and Hydrochlorothiazide
ANDA #202544
Hydrochlorothiazide; Telmisartan Tablet; Oral ORIG-1 Glenmark Pharms Ltd Approved

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English