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.

July 22, 2019

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Anaprox
NDA #018164
Naproxen Sodium Tablet; Oral SUPPL-64 Atnahs Pharma Us Labeling Approved
Anaprox Ds
NDA #018164
Naproxen Sodium Tablet; Oral SUPPL-64 Atnahs Pharma Us Labeling Approved
Caldolor
NDA #022348
Ibuprofen Solution; Intravenous SUPPL-14 Cumberland Pharms Labeling Approved
Droxia
NDA #016295
Hydroxyurea Capsule; Oral SUPPL-51 Bristol Myers Squibb Labeling Approved
Duexis
NDA #022519
Famotidine; Ibuprofen Tablet; Oral SUPPL-12 Horizon Labeling Approved
Ec-Naprosyn
NDA #020067
Naproxen Tablet, Delayed Release; Oral SUPPL-21 Atnahs Pharma Us Labeling Approved
Hydrea
NDA #016295
Hydroxyurea Capsule; Oral SUPPL-51 Bristol Myers Squibb Labeling Approved
Metformin Hydrochloride
ANDA #202917
Metformin Hydrochloride Tablet, Extended Release; Oral SUPPL-7 Sun Pharm Manufacturing (CMC) Approved
Morphine Sulfate
ANDA #210610
Morphine Sulfate Tablet; Oral ORIG-1 Upsher Smith Labs Approved
Naprelan
NDA #020353
Naproxen Sodium Tablet, Extended Release; Oral SUPPL-36 Alvogen Labeling Approved
Naprelan
NDA #020353
Naproxen Sodium Tablet, Extended Release; Oral SUPPL-36 Alvogen Labeling Approved
Naprelan
NDA #020353
Naproxen Sodium Tablet, Extended Release; Oral SUPPL-36 Alvogen Labeling Approved
Naprosyn
NDA #017581
Naproxen Tablet; Oral SUPPL-114 Atnahs Pharma Us Labeling Approved
Naprosyn
NDA #018965
Naproxen Suspension; Oral SUPPL-26 Atnahs Pharma Us Labeling Approved
Ramelteon
ANDA #211567
Ramelteon Tablet; Oral ORIG-1 Zydus Pharms Approved
Serevent
NDA #020692
Salmeterol Xinafoate Powder; Inhalation SUPPL-47 Glaxosmithkline Labeling Approved
Vimovo
NDA #022511
Esomeprazole Magnesium; Naproxen Tablet, Delayed Release; Oral SUPPL-24 Horizon Labeling Approved

July 21, 2019

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Meropenem
ANDA #091404
Meropenem Injectable; Injection SUPPL-15 Acs Dobfar Labeling Approved
Meropenem
ANDA #091404
Meropenem Injectable; Injection SUPPL-16 Acs Dobfar Labeling Approved
Meropenem
ANDA #091404
Meropenem Injectable; Injection SUPPL-18 Acs Dobfar Labeling Approved
Meropenem
ANDA #091404
Meropenem Injectable; Injection SUPPL-19 Acs Dobfar Labeling Approved
Meropenem
ANDA #091404
Meropenem Injectable; Injection SUPPL-20 Acs Dobfar Labeling Approved
Meropenem
ANDA #205883
Meropenem Injectable; Injection SUPPL-1 Amneal Pharms Labeling Approved
Meropenem
ANDA #205883
Meropenem Injectable; Injection SUPPL-3 Amneal Pharms Labeling Approved
Meropenem
ANDA #205883
Meropenem Injectable; Injection SUPPL-4 Amneal Pharms Labeling Approved
Meropenem
ANDA #205883
Meropenem Injectable; Injection SUPPL-5 Amneal Pharms Labeling Approved
Meropenem
ANDA #205883
Meropenem Injectable; Injection SUPPL-6 Amneal Pharms Labeling Approved
Meropenem
ANDA #206141
Meropenem Injectable; Injection SUPPL-1 Gland Pharma Ltd Labeling Approved
Meropenem
ANDA #206141
Meropenem Injectable; Injection SUPPL-2 Gland Pharma Ltd Labeling Approved
Meropenem
ANDA #206141
Meropenem Injectable; Injection SUPPL-3 Gland Pharma Ltd Labeling Approved
Meropenem
ANDA #206141
Meropenem Injectable; Injection SUPPL-4 Gland Pharma Ltd Labeling Approved
Meropenem
ANDA #206141
Meropenem Injectable; Injection SUPPL-5 Gland Pharma Ltd Labeling Approved

July 19, 2019

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Apremilast
ANDA #211782
Apremilast Unknown ORIG-1 Amneal Pharms Co Tentative Approval
Clobazam
ANDA #211259
Clobazam Suspension; Oral SUPPL-1 Mylan Manufacturing (CMC) Approved
Clopidogrel Bisulfate
ANDA #202925
Clopidogrel Bisulfate Tablet; Oral SUPPL-7 Accord Hlthcare Labeling Approved
Clopidogrel Bisulfate
ANDA #202925
Clopidogrel Bisulfate Tablet; Oral SUPPL-8 Accord Hlthcare Labeling Approved
Clopidogrel Bisulfate
ANDA #202925
Clopidogrel Bisulfate Tablet; Oral SUPPL-9 Accord Hlthcare Labeling Approved
Clopidogrel Bisulfate
ANDA #202925
Clopidogrel Bisulfate Tablet; Oral SUPPL-10 Accord Hlthcare Labeling Approved
Copaxone
NDA #020622
Glatiramer Acetate For Solution; Subcutaneous SUPPL-106 Teva Pharms Usa Labeling Approved
Copaxone
NDA #020622
Glatiramer Acetate Injectable; Subcutaneous SUPPL-106 Teva Pharms Usa Labeling Approved
Dapagliflozin
ANDA #211560
Dapagliflozin Unknown ORIG-1 Alembic Pharms Ltd Tentative Approval
Dexmethylphenidate Hydrochloride
ANDA #212631
Dexmethylphenidate Hydrochloride Tablet; Oral ORIG-1 Alkem Labs Ltd Approved
Drizalma Sprinkle
NDA #212516
Duloxetine Capsule, Delayed Release; Oral ORIG-1 Sun Pharma Global Type 5 - New Formulation or New Manufacturer Approved
Erlotinib
ANDA #210300
Erlotinib Unknown ORIG-1 Sun Pharm Industries Tentative Approval
Imfinzi
BLA #761069
Durvalumab Injectable; Injection SUPPL-13 Astrazeneca Uk Ltd Efficacy Approved
Otezla
NDA #205437
Apremilast Tablet; Oral SUPPL-7 Celgene Corp Efficacy Approved
Pregabalin
ANDA #203459
Pregabalin Capsule; Oral ORIG-1 Alembic Pharms Ltd Approved
Pregabalin
ANDA #207623
Pregabalin Solution; Oral ORIG-1 Alkem Labs Ltd Approved
Pregabalin
ANDA #207799
Pregabalin Capsule; Oral ORIG-1 Alkem Labs Ltd Approved
Pregabalin
ANDA #208677
Pregabalin Capsule; Oral ORIG-1 Sciegen Pharms Inc Approved
Pregabalin
ANDA #209357
Pregabalin Capsule; Oral ORIG-1 Msn Labs Pvt Ltd Approved
Pregabalin
ANDA #209664
Pregabalin Capsule; Oral ORIG-1 Dr Reddys Approved
Pregabalin
ANDA #209743
Pregabalin Capsule; Oral ORIG-1 Amneal Pharms Co Approved
Pregabalin
ANDA #210432
Pregabalin Capsule; Oral ORIG-1 Rising Approved
Pregabalin
ANDA #211384
Pregabalin Capsule; Oral ORIG-1 Invagen Pharms Approved
Zyban
NDA #020711
Bupropion Hydrochloride Tablet, Extended Release; Oral SUPPL-48 Glaxosmithkline Labeling Approved

July 18, 2019

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Bevyxxa
NDA #208383
Betrixaban Capsule; Oral SUPPL-6 Portola Pharms Inc Labeling Approved
Fenofibric Acid
ANDA #211626
Choline Fenofibrate Capsule, Delayed Release; Oral ORIG-1 Graviti Pharms Approved
Lamisil At
NDA #021124
Terbinafine Hydrochloride Solution; Topical SUPPL-15 Glaxosmithkline Cons Manufacturing (CMC) Approved
Lamisil At
NDA #021124
Terbinafine Hydrochloride Spray; Topical SUPPL-15 Glaxosmithkline Cons Manufacturing (CMC) Approved
Lialda
NDA #022000
Mesalamine Tablet, Delayed Release; Oral SUPPL-18 Shire Labeling Approved
Megace
NDA #020264
Megestrol Acetate Suspension; Oral SUPPL-21 Bristol Myers Squibb Labeling Approved
Mepron
NDA #020500
Atovaquone Suspension; Oral SUPPL-19 Glaxosmithkline Llc Labeling Approved
Olmesartan Medoxomil
ANDA #207135
Olmesartan Medoxomil Tablet; Oral ORIG-1 Umedica Labs Pvt Ltd Approved
Prostin Vr Pediatric
NDA #018484
Alprostadil Injectable; Injection SUPPL-28 Pharmacia and Upjohn Labeling Approved
Zinc Sulfate
NDA #209377
Zinc Sulfate Injectable; Injection ORIG-1 American Regent Inc Type 5 - New Formulation or New Manufacturer Approved

July 17, 2019

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Dapagliflozin
ANDA #211312
Dapagliflozin Unknown ORIG-1 Sandoz Inc Tentative Approval
Dextroamp Saccharate, Amp Aspartate, Dextroamp Sulfate and Amp Sulfate
ANDA #210080
Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate Capsule, Extended Release; Oral ORIG-1 Nesher Pharms Approved
Lamisil
NDA #020980
Terbinafine Hydrochloride Cream; Topical SUPPL-12 Glaxosmithkline Labeling Approved
Rivastigmine Tartrate
ANDA #091072
Rivastigmine Tartrate Capsule; Oral SUPPL-8 Apotex Inc Labeling Approved
Rivastigmine Tartrate
ANDA #091072
Rivastigmine Tartrate Capsule; Oral SUPPL-7 Apotex Inc Labeling Approved
Rivastigmine Tartrate
ANDA #091072
Rivastigmine Tartrate Capsule; Oral SUPPL-8 Apotex Inc Labeling Approved
Tranexamic Acid
ANDA #212360
Tranexamic Acid Injectable; Injection ORIG-1 Caplin Approved
Tranexamic Acid
ANDA #212676
Tranexamic Acid Injectable; Injection ORIG-1 Apollo Pharms Inc Approved

July 16, 2019

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Dactinomycin
ANDA #207232
Dactinomycin Injectable; Injection ORIG-1 Hisun Pharm Hangzhou Approved
Darzalex
BLA #761036
Daratumumab Injectable; Injection SUPPL-19 Janssen Biotech Labeling Approved
Enzalutamide
ANDA #211465
Enzalutamide Unknown ORIG-1 Eugia Pharma Tentative Approval
Everolimus
ANDA #207486
Everolimus Tablet; Oral ORIG-1 West-Ward Pharms Int Tentative Approval
Fluconazole
ANDA #076077
Fluconazole Tablet; Oral SUPPL-13 Ivax Sub Teva Pharms Labeling Approved
Fluconazole
ANDA #076077
Fluconazole Tablet; Oral SUPPL-14 Ivax Sub Teva Pharms Labeling Approved
Fluconazole
ANDA #076077
Fluconazole Tablet; Oral SUPPL-15 Ivax Sub Teva Pharms Labeling Approved
Fluconazole
ANDA #076077
Fluconazole Tablet; Oral SUPPL-16 Ivax Sub Teva Pharms Labeling Approved
Fluconazole
ANDA #076077
Fluconazole Tablet; Oral SUPPL-13 Ivax Sub Teva Pharms Labeling Approved
Fluconazole
ANDA #076077
Fluconazole Tablet; Oral SUPPL-14 Ivax Sub Teva Pharms Labeling Approved
Fluconazole
ANDA #076077
Fluconazole Tablet; Oral SUPPL-15 Ivax Sub Teva Pharms Labeling Approved
Fluconazole
ANDA #076077
Fluconazole Tablet; Oral SUPPL-16 Ivax Sub Teva Pharms Labeling Approved
Fluconazole
ANDA #076658
Fluconazole Tablet; Oral SUPPL-14 Dr Reddys Labs Inc Labeling Approved
Fluconazole
ANDA #076658
Fluconazole Tablet; Oral SUPPL-15 Dr Reddys Labs Inc Labeling Approved
Fluconazole
ANDA #076658
Fluconazole Tablet; Oral SUPPL-16 Dr Reddys Labs Inc Labeling Approved
Fluconazole
ANDA #076658
Fluconazole Tablet; Oral SUPPL-17 Dr Reddys Labs Inc Labeling Approved
Fluconazole
ANDA #076658
Fluconazole Tablet; Oral SUPPL-14 Dr Reddys Labs Inc Labeling Approved
Fluconazole
ANDA #076658
Fluconazole Tablet; Oral SUPPL-15 Dr Reddys Labs Inc Labeling Approved
Fluconazole
ANDA #076658
Fluconazole Tablet; Oral SUPPL-16 Dr Reddys Labs Inc Labeling Approved
Fluconazole
ANDA #076658
Fluconazole Tablet; Oral SUPPL-17 Dr Reddys Labs Inc Labeling Approved
Fluconazole
ANDA #208963
Fluconazole Tablet; Oral SUPPL-1 Zydus Pharms Labeling Approved
Fluconazole
ANDA #208963
Fluconazole Tablet; Oral SUPPL-2 Zydus Pharms Labeling Approved
Fluconazole
ANDA #208963
Fluconazole Tablet; Oral SUPPL-3 Zydus Pharms Labeling Approved
Fluconazole
ANDA #208963
Fluconazole Tablet; Oral SUPPL-5 Zydus Pharms Labeling Approved
Fluconazole
ANDA #208963
Fluconazole Tablet; Oral SUPPL-1 Zydus Pharms Labeling Approved
Fluconazole
ANDA #208963
Fluconazole Tablet; Oral SUPPL-2 Zydus Pharms Labeling Approved
Fluconazole
ANDA #208963
Fluconazole Tablet; Oral SUPPL-3 Zydus Pharms Labeling Approved
Fluconazole
ANDA #208963
Fluconazole Tablet; Oral SUPPL-5 Zydus Pharms Labeling Approved
Gefitinib
ANDA #211826
Gefitinib Unknown ORIG-1 Cipla Ltd Tentative Approval
Lamivudine and Zidovudine
ANDA #079128
Lamivudine; Zidovudine Tablet; Oral SUPPL-13 Strides Pharma Labeling Approved
Lamivudine and Zidovudine
ANDA #079128
Lamivudine; Zidovudine Tablet; Oral SUPPL-14 Strides Pharma Labeling Approved
Linezolid
ANDA #204764
Linezolid Solution; Intravenous SUPPL-3 Fresenius Kabi Usa Labeling Approved
Mekinist
NDA #204114
Trametinib Dimethyl Sulfoxide Tablet; Oral SUPPL-13 Novartis Pharms Corp Labeling Approved
Methadone Hydrochloride
ANDA #090635
Methadone Hydrochloride Tablet; Oral SUPPL-19 Thepharmanetwork Llc Labeling Approved
Methadone Hydrochloride
ANDA #090635
Methadone Hydrochloride Tablet; Oral SUPPL-19 Thepharmanetwork Llc Labeling Approved
Methadone Hydrochloride
ANDA #090635
Methadone Hydrochloride Tablet; Oral SUPPL-21 Thepharmanetwork Llc Labeling Approved
Methadone Hydrochloride
ANDA #090635
Methadone Hydrochloride Tablet; Oral SUPPL-19 Thepharmanetwork Llc Labeling Approved
Methadone Hydrochloride
ANDA #090635
Methadone Hydrochloride Tablet; Oral SUPPL-21 Thepharmanetwork Llc Labeling Approved
Methadone Hydrochloride
ANDA #090635
Methadone Hydrochloride Tablet; Oral SUPPL-22 Thepharmanetwork Llc Labeling Approved
Metoclopramide Hydrochloride
ANDA #070184
Metoclopramide Hydrochloride Tablet; Oral SUPPL-69 Teva Labeling Approved
Metoclopramide Hydrochloride
ANDA #070184
Metoclopramide Hydrochloride Tablet; Oral SUPPL-69 Teva Labeling Approved
Metoclopramide Hydrochloride
ANDA #071250
Metoclopramide Hydrochloride Tablet; Oral SUPPL-37 Impax Labs Inc Labeling Approved
Metoclopramide Hydrochloride
ANDA #072801
Metoclopramide Hydrochloride Tablet; Oral SUPPL-44 Teva Labeling Approved
Metoclopramide Hydrochloride
ANDA #072801
Metoclopramide Hydrochloride Tablet; Oral SUPPL-44 Teva Labeling Approved
Metoclopramide Hydrochloride
ANDA #077878
Metoclopramide Hydrochloride Tablet; Oral SUPPL-12 Vintage Pharms Labeling Approved
Mupirocin
ANDA #201587
Mupirocin Calcium Cream; Topical SUPPL-9 Glenmark Pharms Inc Labeling Approved
Ocrevus
BLA #761053
Ocrelizumab Injectable; Injection SUPPL-18 Genentech Inc Labeling Approved
Pentasa
NDA #020049
Mesalamine Capsule, Extended Release; Oral SUPPL-32 Shire Labeling Approved
Recarbrio
NDA #212819
Imipenem;Cilastatin;Relebactam Injectable; Intravenous ORIG-1 Merck Sharp Dohme Type 1 - New Molecular Entity and Type 4 - New Combination Approved
Rivastigmine Tartrate
ANDA #077130
Rivastigmine Tartrate Capsule; Oral SUPPL-5 Dr Reddys Labs Inc Labeling Approved
Rivastigmine Tartrate
ANDA #077130
Rivastigmine Tartrate Capsule; Oral SUPPL-6 Dr Reddys Labs Inc Labeling Approved
Tafinlar
NDA #202806
Dabrafenib Mesylate Capsule; Oral SUPPL-13 Novartis Pharms Corp Labeling Approved
Temozolomide
ANDA #203691
Temozolomide Capsule; Oral SUPPL-4 Amneal Pharms Labeling Approved
Temozolomide
ANDA #203691
Temozolomide Capsule; Oral SUPPL-4 Amneal Pharms Labeling Approved

July 15, 2019

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Austedo
NDA #208082
Deutetrabenazine Tablet; Oral SUPPL-4 Teva Branded Pharm Labeling Approved
Dextrose 5% and Potassium Chloride 0.075% In Plastic Container
NDA #017634
Dextrose; Potassium Chloride Injectable; Injection SUPPL-76 Baxter Hlthcare Labeling Approved
Dextrose 5% and Potassium Chloride 0.15% In Plastic Container
NDA #017634
Dextrose; Potassium Chloride Injectable; Injection SUPPL-76 Baxter Hlthcare Labeling Approved
Dextrose 5% and Potassium Chloride 0.224% In Plastic Container
NDA #017634
Dextrose; Potassium Chloride Injectable; Injection SUPPL-76 Baxter Hlthcare Labeling Approved
Dextrose 5% and Potassium Chloride 0.3% In Plastic Container
NDA #017634
Dextrose; Potassium Chloride Injectable; Injection SUPPL-76 Baxter Hlthcare Labeling Approved
Heparin Sodium 1,000 Units and Sodium Chloride 0.9% In Plastic Container
NDA #018609
Heparin Sodium Injectable; Injection SUPPL-54 Baxter Hlthcare Labeling Approved
Heparin Sodium 2,000 Units and Sodium Chloride 0.9% In Plastic Container
NDA #018609
Heparin Sodium Injectable; Injection SUPPL-54 Baxter Hlthcare Labeling Approved
Heparin Sodium 5,000 Units and Sodium Chloride 0.9% In Plastic Container
NDA #018609
Heparin Sodium Injectable; Injection SUPPL-54 Baxter Hlthcare Labeling Approved
Icatibant Acetate
ANDA #210118
Icatibant Acetate Injectable; Subcutaneous ORIG-1 Teva Pharms Usa Approved
Imbruvica
NDA #205552
Ibrutinib Capsule; Oral SUPPL-28 Pharmacyclics Inc Labeling Approved
Imbruvica
NDA #210563
Ibrutinib Tablet; Oral SUPPL-3 Pharmacyclics Inc Labeling Approved
Ingrezza
NDA #209241
Valbenazine Tosylate Capsule; Oral SUPPL-12 Neurocrine Labeling Approved
Methylphenidate Hydrochloride
ANDA #204659
Methylphenidate Hydrochloride Tablet, Extended Release; Oral ORIG-1 Par Pharm Approved
Rapamune
NDA #021083
Sirolimus Solution; Oral SUPPL-64 Pf Prism Cv Labeling Approved
Rapamune
NDA #021110
Sirolimus Tablet; Oral SUPPL-83 Pf Prism Cv Labeling Approved

July 22, 2019

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Anaprox
NDA #018164
Naproxen Sodium Tablet; Oral SUPPL-64 Atnahs Pharma Us Labeling Approved
Anaprox Ds
NDA #018164
Naproxen Sodium Tablet; Oral SUPPL-64 Atnahs Pharma Us Labeling Approved
Caldolor
NDA #022348
Ibuprofen Solution; Intravenous SUPPL-14 Cumberland Pharms Labeling Approved
Droxia
NDA #016295
Hydroxyurea Capsule; Oral SUPPL-51 Bristol Myers Squibb Labeling Approved
Duexis
NDA #022519
Famotidine; Ibuprofen Tablet; Oral SUPPL-12 Horizon Labeling Approved
Ec-Naprosyn
NDA #020067
Naproxen Tablet, Delayed Release; Oral SUPPL-21 Atnahs Pharma Us Labeling Approved
Hydrea
NDA #016295
Hydroxyurea Capsule; Oral SUPPL-51 Bristol Myers Squibb Labeling Approved
Metformin Hydrochloride
ANDA #202917
Metformin Hydrochloride Tablet, Extended Release; Oral SUPPL-7 Sun Pharm Manufacturing (CMC) Approved
Morphine Sulfate
ANDA #210610
Morphine Sulfate Tablet; Oral ORIG-1 Upsher Smith Labs Approved
Naprelan
NDA #020353
Naproxen Sodium Tablet, Extended Release; Oral SUPPL-36 Alvogen Labeling Approved
Naprelan
NDA #020353
Naproxen Sodium Tablet, Extended Release; Oral SUPPL-36 Alvogen Labeling Approved
Naprelan
NDA #020353
Naproxen Sodium Tablet, Extended Release; Oral SUPPL-36 Alvogen Labeling Approved
Naprosyn
NDA #017581
Naproxen Tablet; Oral SUPPL-114 Atnahs Pharma Us Labeling Approved
Naprosyn
NDA #018965
Naproxen Suspension; Oral SUPPL-26 Atnahs Pharma Us Labeling Approved
Ramelteon
ANDA #211567
Ramelteon Tablet; Oral ORIG-1 Zydus Pharms Approved
Serevent
NDA #020692
Salmeterol Xinafoate Powder; Inhalation SUPPL-47 Glaxosmithkline Labeling Approved
Vimovo
NDA #022511
Esomeprazole Magnesium; Naproxen Tablet, Delayed Release; Oral SUPPL-24 Horizon Labeling Approved

July 21, 2019

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Meropenem
ANDA #091404
Meropenem Injectable; Injection SUPPL-15 Acs Dobfar Labeling Approved
Meropenem
ANDA #091404
Meropenem Injectable; Injection SUPPL-16 Acs Dobfar Labeling Approved
Meropenem
ANDA #091404
Meropenem Injectable; Injection SUPPL-18 Acs Dobfar Labeling Approved
Meropenem
ANDA #091404
Meropenem Injectable; Injection SUPPL-19 Acs Dobfar Labeling Approved
Meropenem
ANDA #091404
Meropenem Injectable; Injection SUPPL-20 Acs Dobfar Labeling Approved
Meropenem
ANDA #205883
Meropenem Injectable; Injection SUPPL-1 Amneal Pharms Labeling Approved
Meropenem
ANDA #205883
Meropenem Injectable; Injection SUPPL-3 Amneal Pharms Labeling Approved
Meropenem
ANDA #205883
Meropenem Injectable; Injection SUPPL-4 Amneal Pharms Labeling Approved
Meropenem
ANDA #205883
Meropenem Injectable; Injection SUPPL-5 Amneal Pharms Labeling Approved
Meropenem
ANDA #205883
Meropenem Injectable; Injection SUPPL-6 Amneal Pharms Labeling Approved
Meropenem
ANDA #206141
Meropenem Injectable; Injection SUPPL-1 Gland Pharma Ltd Labeling Approved
Meropenem
ANDA #206141
Meropenem Injectable; Injection SUPPL-2 Gland Pharma Ltd Labeling Approved
Meropenem
ANDA #206141
Meropenem Injectable; Injection SUPPL-3 Gland Pharma Ltd Labeling Approved
Meropenem
ANDA #206141
Meropenem Injectable; Injection SUPPL-4 Gland Pharma Ltd Labeling Approved
Meropenem
ANDA #206141
Meropenem Injectable; Injection SUPPL-5 Gland Pharma Ltd Labeling Approved

July 19, 2019

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Apremilast
ANDA #211782
Apremilast Unknown ORIG-1 Amneal Pharms Co Tentative Approval
Clobazam
ANDA #211259
Clobazam Suspension; Oral SUPPL-1 Mylan Manufacturing (CMC) Approved
Clopidogrel Bisulfate
ANDA #202925
Clopidogrel Bisulfate Tablet; Oral SUPPL-7 Accord Hlthcare Labeling Approved
Clopidogrel Bisulfate
ANDA #202925
Clopidogrel Bisulfate Tablet; Oral SUPPL-8 Accord Hlthcare Labeling Approved
Clopidogrel Bisulfate
ANDA #202925
Clopidogrel Bisulfate Tablet; Oral SUPPL-9 Accord Hlthcare Labeling Approved
Clopidogrel Bisulfate
ANDA #202925
Clopidogrel Bisulfate Tablet; Oral SUPPL-10 Accord Hlthcare Labeling Approved
Copaxone
NDA #020622
Glatiramer Acetate For Solution; Subcutaneous SUPPL-106 Teva Pharms Usa Labeling Approved
Copaxone
NDA #020622
Glatiramer Acetate Injectable; Subcutaneous SUPPL-106 Teva Pharms Usa Labeling Approved
Dapagliflozin
ANDA #211560
Dapagliflozin Unknown ORIG-1 Alembic Pharms Ltd Tentative Approval
Dexmethylphenidate Hydrochloride
ANDA #212631
Dexmethylphenidate Hydrochloride Tablet; Oral ORIG-1 Alkem Labs Ltd Approved
Drizalma Sprinkle
NDA #212516
Duloxetine Capsule, Delayed Release; Oral ORIG-1 Sun Pharma Global Type 5 - New Formulation or New Manufacturer Approved
Erlotinib
ANDA #210300
Erlotinib Unknown ORIG-1 Sun Pharm Industries Tentative Approval
Imfinzi
BLA #761069
Durvalumab Injectable; Injection SUPPL-13 Astrazeneca Uk Ltd Efficacy Approved
Otezla
NDA #205437
Apremilast Tablet; Oral SUPPL-7 Celgene Corp Efficacy Approved
Pregabalin
ANDA #203459
Pregabalin Capsule; Oral ORIG-1 Alembic Pharms Ltd Approved
Pregabalin
ANDA #207623
Pregabalin Solution; Oral ORIG-1 Alkem Labs Ltd Approved
Pregabalin
ANDA #207799
Pregabalin Capsule; Oral ORIG-1 Alkem Labs Ltd Approved
Pregabalin
ANDA #208677
Pregabalin Capsule; Oral ORIG-1 Sciegen Pharms Inc Approved
Pregabalin
ANDA #209357
Pregabalin Capsule; Oral ORIG-1 Msn Labs Pvt Ltd Approved
Pregabalin
ANDA #209664
Pregabalin Capsule; Oral ORIG-1 Dr Reddys Approved
Pregabalin
ANDA #209743
Pregabalin Capsule; Oral ORIG-1 Amneal Pharms Co Approved
Pregabalin
ANDA #210432
Pregabalin Capsule; Oral ORIG-1 Rising Approved
Pregabalin
ANDA #211384
Pregabalin Capsule; Oral ORIG-1 Invagen Pharms Approved
Zyban
NDA #020711
Bupropion Hydrochloride Tablet, Extended Release; Oral SUPPL-48 Glaxosmithkline Labeling Approved

July 18, 2019

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Bevyxxa
NDA #208383
Betrixaban Capsule; Oral SUPPL-6 Portola Pharms Inc Labeling Approved
Fenofibric Acid
ANDA #211626
Choline Fenofibrate Capsule, Delayed Release; Oral ORIG-1 Graviti Pharms Approved
Lamisil At
NDA #021124
Terbinafine Hydrochloride Solution; Topical SUPPL-15 Glaxosmithkline Cons Manufacturing (CMC) Approved
Lamisil At
NDA #021124
Terbinafine Hydrochloride Spray; Topical SUPPL-15 Glaxosmithkline Cons Manufacturing (CMC) Approved
Lialda
NDA #022000
Mesalamine Tablet, Delayed Release; Oral SUPPL-18 Shire Labeling Approved
Megace
NDA #020264
Megestrol Acetate Suspension; Oral SUPPL-21 Bristol Myers Squibb Labeling Approved
Mepron
NDA #020500
Atovaquone Suspension; Oral SUPPL-19 Glaxosmithkline Llc Labeling Approved
Olmesartan Medoxomil
ANDA #207135
Olmesartan Medoxomil Tablet; Oral ORIG-1 Umedica Labs Pvt Ltd Approved
Prostin Vr Pediatric
NDA #018484
Alprostadil Injectable; Injection SUPPL-28 Pharmacia and Upjohn Labeling Approved
Zinc Sulfate
NDA #209377
Zinc Sulfate Injectable; Injection ORIG-1 American Regent Inc Type 5 - New Formulation or New Manufacturer Approved

July 17, 2019

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Dapagliflozin
ANDA #211312
Dapagliflozin Unknown ORIG-1 Sandoz Inc Tentative Approval
Dextroamp Saccharate, Amp Aspartate, Dextroamp Sulfate and Amp Sulfate
ANDA #210080
Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate Capsule, Extended Release; Oral ORIG-1 Nesher Pharms Approved
Lamisil
NDA #020980
Terbinafine Hydrochloride Cream; Topical SUPPL-12 Glaxosmithkline Labeling Approved
Rivastigmine Tartrate
ANDA #091072
Rivastigmine Tartrate Capsule; Oral SUPPL-8 Apotex Inc Labeling Approved
Rivastigmine Tartrate
ANDA #091072
Rivastigmine Tartrate Capsule; Oral SUPPL-7 Apotex Inc Labeling Approved
Rivastigmine Tartrate
ANDA #091072
Rivastigmine Tartrate Capsule; Oral SUPPL-8 Apotex Inc Labeling Approved
Tranexamic Acid
ANDA #212360
Tranexamic Acid Injectable; Injection ORIG-1 Caplin Approved
Tranexamic Acid
ANDA #212676
Tranexamic Acid Injectable; Injection ORIG-1 Apollo Pharms Inc Approved

July 16, 2019

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Dactinomycin
ANDA #207232
Dactinomycin Injectable; Injection ORIG-1 Hisun Pharm Hangzhou Approved
Darzalex
BLA #761036
Daratumumab Injectable; Injection SUPPL-19 Janssen Biotech Labeling Approved
Enzalutamide
ANDA #211465
Enzalutamide Unknown ORIG-1 Eugia Pharma Tentative Approval
Everolimus
ANDA #207486
Everolimus Tablet; Oral ORIG-1 West-Ward Pharms Int Tentative Approval
Fluconazole
ANDA #076077
Fluconazole Tablet; Oral SUPPL-13 Ivax Sub Teva Pharms Labeling Approved
Fluconazole
ANDA #076077
Fluconazole Tablet; Oral SUPPL-14 Ivax Sub Teva Pharms Labeling Approved
Fluconazole
ANDA #076077
Fluconazole Tablet; Oral SUPPL-15 Ivax Sub Teva Pharms Labeling Approved
Fluconazole
ANDA #076077
Fluconazole Tablet; Oral SUPPL-16 Ivax Sub Teva Pharms Labeling Approved
Fluconazole
ANDA #076077
Fluconazole Tablet; Oral SUPPL-13 Ivax Sub Teva Pharms Labeling Approved
Fluconazole
ANDA #076077
Fluconazole Tablet; Oral SUPPL-14 Ivax Sub Teva Pharms Labeling Approved
Fluconazole
ANDA #076077
Fluconazole Tablet; Oral SUPPL-15 Ivax Sub Teva Pharms Labeling Approved
Fluconazole
ANDA #076077
Fluconazole Tablet; Oral SUPPL-16 Ivax Sub Teva Pharms Labeling Approved
Fluconazole
ANDA #076658
Fluconazole Tablet; Oral SUPPL-14 Dr Reddys Labs Inc Labeling Approved
Fluconazole
ANDA #076658
Fluconazole Tablet; Oral SUPPL-15 Dr Reddys Labs Inc Labeling Approved
Fluconazole
ANDA #076658
Fluconazole Tablet; Oral SUPPL-16 Dr Reddys Labs Inc Labeling Approved
Fluconazole
ANDA #076658
Fluconazole Tablet; Oral SUPPL-17 Dr Reddys Labs Inc Labeling Approved
Fluconazole
ANDA #076658
Fluconazole Tablet; Oral SUPPL-14 Dr Reddys Labs Inc Labeling Approved
Fluconazole
ANDA #076658
Fluconazole Tablet; Oral SUPPL-15 Dr Reddys Labs Inc Labeling Approved
Fluconazole
ANDA #076658
Fluconazole Tablet; Oral SUPPL-16 Dr Reddys Labs Inc Labeling Approved
Fluconazole
ANDA #076658
Fluconazole Tablet; Oral SUPPL-17 Dr Reddys Labs Inc Labeling Approved
Fluconazole
ANDA #208963
Fluconazole Tablet; Oral SUPPL-1 Zydus Pharms Labeling Approved
Fluconazole
ANDA #208963
Fluconazole Tablet; Oral SUPPL-2 Zydus Pharms Labeling Approved
Fluconazole
ANDA #208963
Fluconazole Tablet; Oral SUPPL-3 Zydus Pharms Labeling Approved
Fluconazole
ANDA #208963
Fluconazole Tablet; Oral SUPPL-5 Zydus Pharms Labeling Approved
Fluconazole
ANDA #208963
Fluconazole Tablet; Oral SUPPL-1 Zydus Pharms Labeling Approved
Fluconazole
ANDA #208963
Fluconazole Tablet; Oral SUPPL-2 Zydus Pharms Labeling Approved
Fluconazole
ANDA #208963
Fluconazole Tablet; Oral SUPPL-3 Zydus Pharms Labeling Approved
Fluconazole
ANDA #208963
Fluconazole Tablet; Oral SUPPL-5 Zydus Pharms Labeling Approved
Gefitinib
ANDA #211826
Gefitinib Unknown ORIG-1 Cipla Ltd Tentative Approval
Lamivudine and Zidovudine
ANDA #079128
Lamivudine; Zidovudine Tablet; Oral SUPPL-13 Strides Pharma Labeling Approved
Lamivudine and Zidovudine
ANDA #079128
Lamivudine; Zidovudine Tablet; Oral SUPPL-14 Strides Pharma Labeling Approved
Linezolid
ANDA #204764
Linezolid Solution; Intravenous SUPPL-3 Fresenius Kabi Usa Labeling Approved
Mekinist
NDA #204114
Trametinib Dimethyl Sulfoxide Tablet; Oral SUPPL-13 Novartis Pharms Corp Labeling Approved
Methadone Hydrochloride
ANDA #090635
Methadone Hydrochloride Tablet; Oral SUPPL-19 Thepharmanetwork Llc Labeling Approved
Methadone Hydrochloride
ANDA #090635
Methadone Hydrochloride Tablet; Oral SUPPL-19 Thepharmanetwork Llc Labeling Approved
Methadone Hydrochloride
ANDA #090635
Methadone Hydrochloride Tablet; Oral SUPPL-21 Thepharmanetwork Llc Labeling Approved
Methadone Hydrochloride
ANDA #090635
Methadone Hydrochloride Tablet; Oral SUPPL-19 Thepharmanetwork Llc Labeling Approved
Methadone Hydrochloride
ANDA #090635
Methadone Hydrochloride Tablet; Oral SUPPL-21 Thepharmanetwork Llc Labeling Approved
Methadone Hydrochloride
ANDA #090635
Methadone Hydrochloride Tablet; Oral SUPPL-22 Thepharmanetwork Llc Labeling Approved
Metoclopramide Hydrochloride
ANDA #070184
Metoclopramide Hydrochloride Tablet; Oral SUPPL-69 Teva Labeling Approved
Metoclopramide Hydrochloride
ANDA #070184
Metoclopramide Hydrochloride Tablet; Oral SUPPL-69 Teva Labeling Approved
Metoclopramide Hydrochloride
ANDA #071250
Metoclopramide Hydrochloride Tablet; Oral SUPPL-37 Impax Labs Inc Labeling Approved
Metoclopramide Hydrochloride
ANDA #072801
Metoclopramide Hydrochloride Tablet; Oral SUPPL-44 Teva Labeling Approved
Metoclopramide Hydrochloride
ANDA #072801
Metoclopramide Hydrochloride Tablet; Oral SUPPL-44 Teva Labeling Approved
Metoclopramide Hydrochloride
ANDA #077878
Metoclopramide Hydrochloride Tablet; Oral SUPPL-12 Vintage Pharms Labeling Approved
Mupirocin
ANDA #201587
Mupirocin Calcium Cream; Topical SUPPL-9 Glenmark Pharms Inc Labeling Approved
Ocrevus
BLA #761053
Ocrelizumab Injectable; Injection SUPPL-18 Genentech Inc Labeling Approved
Pentasa
NDA #020049
Mesalamine Capsule, Extended Release; Oral SUPPL-32 Shire Labeling Approved
Recarbrio
NDA #212819
Imipenem;Cilastatin;Relebactam Injectable; Intravenous ORIG-1 Merck Sharp Dohme Type 1 - New Molecular Entity and Type 4 - New Combination Approved
Rivastigmine Tartrate
ANDA #077130
Rivastigmine Tartrate Capsule; Oral SUPPL-5 Dr Reddys Labs Inc Labeling Approved
Rivastigmine Tartrate
ANDA #077130
Rivastigmine Tartrate Capsule; Oral SUPPL-6 Dr Reddys Labs Inc Labeling Approved
Tafinlar
NDA #202806
Dabrafenib Mesylate Capsule; Oral SUPPL-13 Novartis Pharms Corp Labeling Approved
Temozolomide
ANDA #203691
Temozolomide Capsule; Oral SUPPL-4 Amneal Pharms Labeling Approved
Temozolomide
ANDA #203691
Temozolomide Capsule; Oral SUPPL-4 Amneal Pharms Labeling Approved

July 15, 2019

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Austedo
NDA #208082
Deutetrabenazine Tablet; Oral SUPPL-4 Teva Branded Pharm Labeling Approved
Dextrose 5% and Potassium Chloride 0.075% In Plastic Container
NDA #017634
Dextrose; Potassium Chloride Injectable; Injection SUPPL-76 Baxter Hlthcare Labeling Approved
Dextrose 5% and Potassium Chloride 0.15% In Plastic Container
NDA #017634
Dextrose; Potassium Chloride Injectable; Injection SUPPL-76 Baxter Hlthcare Labeling Approved
Dextrose 5% and Potassium Chloride 0.224% In Plastic Container
NDA #017634
Dextrose; Potassium Chloride Injectable; Injection SUPPL-76 Baxter Hlthcare Labeling Approved
Dextrose 5% and Potassium Chloride 0.3% In Plastic Container
NDA #017634
Dextrose; Potassium Chloride Injectable; Injection SUPPL-76 Baxter Hlthcare Labeling Approved
Heparin Sodium 1,000 Units and Sodium Chloride 0.9% In Plastic Container
NDA #018609
Heparin Sodium Injectable; Injection SUPPL-54 Baxter Hlthcare Labeling Approved
Heparin Sodium 2,000 Units and Sodium Chloride 0.9% In Plastic Container
NDA #018609
Heparin Sodium Injectable; Injection SUPPL-54 Baxter Hlthcare Labeling Approved
Heparin Sodium 5,000 Units and Sodium Chloride 0.9% In Plastic Container
NDA #018609
Heparin Sodium Injectable; Injection SUPPL-54 Baxter Hlthcare Labeling Approved
Icatibant Acetate
ANDA #210118
Icatibant Acetate Injectable; Subcutaneous ORIG-1 Teva Pharms Usa Approved
Imbruvica
NDA #205552
Ibrutinib Capsule; Oral SUPPL-28 Pharmacyclics Inc Labeling Approved
Imbruvica
NDA #210563
Ibrutinib Tablet; Oral SUPPL-3 Pharmacyclics Inc Labeling Approved
Ingrezza
NDA #209241
Valbenazine Tosylate Capsule; Oral SUPPL-12 Neurocrine Labeling Approved
Methylphenidate Hydrochloride
ANDA #204659
Methylphenidate Hydrochloride Tablet, Extended Release; Oral ORIG-1 Par Pharm Approved
Rapamune
NDA #021083
Sirolimus Solution; Oral SUPPL-64 Pf Prism Cv Labeling Approved
Rapamune
NDA #021110
Sirolimus Tablet; Oral SUPPL-83 Pf Prism Cv Labeling Approved

July 12, 2019

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Acyclovir
ANDA #209000
Acyclovir Ointment; Topical SUPPL-1 Alembic Pharms Ltd Manufacturing (CMC) Approved
Aemcolo
NDA #210910
Rifamycin Tablet, Delayed Release; Oral SUPPL-1 Cosmo Technologies Labeling Approved
Avonex
BLA #103628
Interferon Beta-1a Vial SUPPL-5264 Biogen Labeling Approved
Avonex
BLA #103628
Interferon Beta-1a Vial SUPPL-5264 Biogen Labeling Approved
Buprenorphine Hydrochloride
ANDA #076931
Buprenorphine Hydrochloride Injectable; Injection SUPPL-11 West-Ward Pharms Int Manufacturing (CMC) Approved
Cerebyx
NDA #020450
Fosphenytoin Sodium Injectable; Injection SUPPL-39 Parke Davis Labeling Approved
Daptomycin
ANDA #212667
Daptomycin Powder; Iv (Infusion) ORIG-1 Accord Hlthcare Approved
Dilantin-125
NDA #008762
Phenytoin Suspension; Oral SUPPL-63 Parke Davis Labeling Approved
Dilantin-30
NDA #008762
Phenytoin Suspension; Oral SUPPL-63 Parke Davis Labeling Approved
Ethacrynic Acid
ANDA #211809
Ethacrynic Acid Tablet; Oral ORIG-1 Agnitio Approved
Gadavist
NDA #201277
Gadobutrol Solution; Intravenous SUPPL-17 Bayer Hlthcare Efficacy Approved
Isosulfan Blue
ANDA #210558
Isosulfan Blue Injectable; Injection ORIG-1 Somerset Theraps Llc Approved
Ivermectin
ANDA #212485
Ivermectin Unknown ORIG-1 Teva Pharms Usa Tentative Approval
Jeuveau
BLA #761085
Prabotulinumtoxina-Xvfs Injectable; Injection SUPPL-1 Evolus Inc Labeling Approved
Sildenafil
ANDA #212440
Sildenafil Unknown ORIG-1 Alkem Labs Ltd Tentative Approval
Technetium Tc99m Mertiatide Kit
ANDA #208994
Technetium Tc-99m Mertiatide Kit Injectable; Injection ORIG-1 Pharmalucence Approved

July 11, 2019

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Albenza
NDA #020666
Albendazole Tablet; Oral SUPPL-12 Impax Labs Inc Labeling Approved

July 10, 2019

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Abiraterone Acetate
ANDA #210686
Abiraterone Acetate Tablet; Oral ORIG-1 Msn Labs Pvt Ltd Approved
Clobazam
ANDA #210746
Clobazam Suspension; Oral ORIG-1 Vistapharm Approved
Cyclosporine
ANDA #210721
Cyclosporine Capsule; Oral ORIG-1 Apotex Inc Approved
Intelence
NDA #022187
Etravirine Tablet; Oral SUPPL-25 Janssen R and D Labeling Approved
Intelence
NDA #022187
Etravirine Tablet; Oral SUPPL-25 Janssen R and D Labeling Approved
Omega-3-Acid Ethyl Esters
ANDA #211355
Omega-3-Acid Ethyl Esters Capsule; Oral ORIG-1 Sofgen Pharms Approved
Plegridy
BLA #125499
Peginterferon Beta-1a Injectable; Injection SUPPL-19 Biogen Idec Inc Labeling Approved
Plegridy
BLA #125499
Peginterferon Beta-1a Injectable; Injection SUPPL-19 Biogen Idec Inc Labeling Approved
Potassium Chloride
NDA #208019
Potassium Chloride For Solution; Oral SUPPL-2 Pharma Res Software Labeling Approved
Sorafenib Tosylate
ANDA #209050
Sorafenib Tosylate Unknown ORIG-1 Yabao Pharm Tentative Approval
Tecfidera
NDA #204063
Dimethyl Fumarate Capsule, Delayed Release; Oral SUPPL-24 Biogen Idec Inc Labeling Approved
Triferic
NDA #206317
Ferric Pyrophosphate Citrate Solution; Intravenous SUPPL-12 Rockwell Medical Inc Labeling Approved

July 9, 2019

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Adapalene
ANDA #091314
Adapalene Gel; Topical SUPPL-5 Glenmark Generics Labeling Approved
Adapalene
ANDA #091314
Adapalene Gel; Topical SUPPL-5 Glenmark Generics Labeling Approved
Advil Allergy and Congestion Relief
NDA #022113
Chlorpheniramine Maleate; Ibuprofen; Phenylephrine Hydrochloride Tablet; Oral SUPPL-7 Pfizer Labeling Approved
Advil Congestion Relief
NDA #022565
Ibuprofen; Phenylephrine Hydrochloride Tablet; Oral SUPPL-5 Pfizer Labeling Approved
Advil Multi-Symptom Cold & Flu
NDA #022113
Chlorpheniramine Maleate; Ibuprofen; Phenylephrine Hydrochloride Tablet; Oral SUPPL-7 Pfizer Labeling Approved
Atropine (Autoinjector)
NDA #212319
Atropine Solution; Intramuscular SUPPL-2 Rafa Labs Ltd Labeling Approved
Bupivacaine Hydrochloride Preservative Free
ANDA #203895
Bupivacaine Hydrochloride Injectable; Injection SUPPL-2 Aurobindo Pharma Ltd Labeling Approved
Docetaxel
NDA #203551
Docetaxel Injectable; Injection SUPPL-7 Actavis Llc Labeling Approved
Docetaxel
NDA #203551
Docetaxel Injectable; Injection SUPPL-7 Actavis Llc Labeling Approved
Imipenem and Cilastatin
ANDA #090577
Cilastatin Sodium; Imipenem Powder; Intravenous SUPPL-10 Acs Dobfar Labeling Approved
Imipenem and Cilastatin
ANDA #090577
Cilastatin Sodium; Imipenem Powder; Intravenous SUPPL-12 Acs Dobfar Labeling Approved
Rebif
BLA #103780
Interferon Beta-1a Syringe SUPPL-5204 Serono Inc Labeling Approved
Rebif
BLA #103780
Interferon Beta-1a Syringe SUPPL-5204 Serono Inc Labeling Approved
Risedronate Sodium
ANDA #203925
Risedronate Sodium Tablet, Delayed Release; Oral ORIG-1 Sun Pharm Approved
Sildenafil Citrate
ANDA #211092
Sildenafil Citrate Unknown ORIG-1 Amneal Pharms Ny Tentative Approval
Telmisartan
ANDA #205150
Telmisartan Tablet; Oral SUPPL-7 Inventia Hlthcare Labeling Approved
Telmisartan
ANDA #205150
Telmisartan Tablet; Oral SUPPL-5 Inventia Hlthcare Labeling Approved
Telmisartan
ANDA #205150
Telmisartan Tablet; Oral SUPPL-7 Inventia Hlthcare Labeling Approved
Voriconazole
ANDA #200265
Voriconazole Tablet; Oral SUPPL-10 Sandoz Inc Labeling Approved
Voriconazole
ANDA #206747
Voriconazole Tablet; Oral SUPPL-1 Cadila Labeling Approved
Voriconazole
ANDA #206747
Voriconazole Tablet; Oral SUPPL-2 Cadila Labeling Approved
Voriconazole
ANDA #206747
Voriconazole Tablet; Oral SUPPL-4 Cadila Labeling Approved
Voriconazole
ANDA #206747
Voriconazole Tablet; Oral SUPPL-1 Cadila Labeling Approved
Voriconazole
ANDA #206747
Voriconazole Tablet; Oral SUPPL-2 Cadila Labeling Approved
Voriconazole
ANDA #206747
Voriconazole Tablet; Oral SUPPL-3 Cadila Labeling Approved
Voriconazole
ANDA #206747
Voriconazole Tablet; Oral SUPPL-4 Cadila Labeling Approved

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