Drugs@FDA: FDA-Approved Drugs

Recent New and Generic Drug Approvals

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

January 22, 2020

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Afinitor
NDA #022334
Everolimus Tablet; Oral SUPPL-45 Novartis Labeling Approved
Afinitor Disperz
NDA #203985
Everolimus Tablet, For Suspension; Oral SUPPL-17 Novartis Pharm Labeling Approved
Tetrabenazine
ANDA #213316
Tetrabenazine Tablet; Oral ORIG-1 Piramal Hlthcare Uk Approved

January 21, 2020

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Bimatoprost
ANDA #210515
Bimatoprost Solution/Drops; Topical ORIG-1 Alembic Pharms Ltd Approved
Desipramine Hydrochloride
ANDA #071588
Desipramine Hydrochloride Tablet; Oral SUPPL-31 Actavis Totowa Labeling Approved
Desipramine Hydrochloride
ANDA #071588
Desipramine Hydrochloride Tablet; Oral SUPPL-31 Actavis Totowa Labeling Approved
Desipramine Hydrochloride
ANDA #071601
Desipramine Hydrochloride Tablet; Oral SUPPL-32 Actavis Totowa Labeling Approved
Desipramine Hydrochloride
ANDA #071601
Desipramine Hydrochloride Tablet; Oral SUPPL-32 Actavis Totowa Labeling Approved
Desipramine Hydrochloride
ANDA #071602
Desipramine Hydrochloride Tablet; Oral SUPPL-29 Actavis Totowa Labeling Approved
Desipramine Hydrochloride
ANDA #071602
Desipramine Hydrochloride Tablet; Oral SUPPL-29 Actavis Totowa Labeling Approved
Desipramine Hydrochloride
ANDA #071766
Desipramine Hydrochloride Tablet; Oral SUPPL-30 Actavis Totowa Labeling Approved
Desipramine Hydrochloride
ANDA #071766
Desipramine Hydrochloride Tablet; Oral SUPPL-30 Actavis Totowa Labeling Approved
Desipramine Hydrochloride
ANDA #074430
Desipramine Hydrochloride Tablet; Oral SUPPL-19 Actavis Totowa Labeling Approved
Desipramine Hydrochloride
ANDA #074430
Desipramine Hydrochloride Tablet; Oral SUPPL-19 Actavis Totowa Labeling Approved
Divalproex Sodium
ANDA #078979
Divalproex Sodium Capsule, Delayed Rel Pellets; Oral SUPPL-18 Dr Reddys Labs Ltd Labeling Approved
Divalproex Sodium
ANDA #078979
Divalproex Sodium Capsule, Delayed Rel Pellets; Oral SUPPL-18 Dr Reddys Labs Ltd Labeling Approved
Divalproex Sodium
ANDA #078979
Divalproex Sodium Capsule, Delayed Rel Pellets; Oral SUPPL-19 Dr Reddys Labs Ltd Labeling Approved
Divalproex Sodium
ANDA #078979
Divalproex Sodium Capsule, Delayed Rel Pellets; Oral SUPPL-20 Dr Reddys Labs Ltd Labeling Approved
Divalproex Sodium
ANDA #078979
Divalproex Sodium Capsule, Delayed Rel Pellets; Oral SUPPL-21 Dr Reddys Labs Ltd Labeling Approved
Divalproex Sodium
ANDA #078979
Divalproex Sodium Capsule, Delayed Rel Pellets; Oral SUPPL-22 Dr Reddys Labs Ltd Labeling Approved
Divalproex Sodium
ANDA #078979
Divalproex Sodium Capsule, Delayed Rel Pellets; Oral SUPPL-18 Dr Reddys Labs Ltd Labeling Approved
Divalproex Sodium
ANDA #078979
Divalproex Sodium Capsule, Delayed Rel Pellets; Oral SUPPL-19 Dr Reddys Labs Ltd Labeling Approved
Divalproex Sodium
ANDA #078979
Divalproex Sodium Capsule, Delayed Rel Pellets; Oral SUPPL-20 Dr Reddys Labs Ltd Labeling Approved
Divalproex Sodium
ANDA #078979
Divalproex Sodium Capsule, Delayed Rel Pellets; Oral SUPPL-21 Dr Reddys Labs Ltd Labeling Approved
Divalproex Sodium
ANDA #078979
Divalproex Sodium Capsule, Delayed Rel Pellets; Oral SUPPL-22 Dr Reddys Labs Ltd Labeling Approved
Esomeprazole Magnesium
ANDA #207193
Esomeprazole Magnesium Capsule, Delayed Release; Oral SUPPL-3 Perrigo R and D Labeling Approved
Esomeprazole Magnesium
ANDA #207193
Esomeprazole Magnesium Capsule, Delayed Release; Oral SUPPL-11 Perrigo R and D Labeling Approved
Esomeprazole Magnesium
ANDA #207193
Esomeprazole Magnesium Capsule, Delayed Release; Oral SUPPL-3 Perrigo R and D Labeling Approved
Esomeprazole Magnesium
ANDA #207193
Esomeprazole Magnesium Capsule, Delayed Release; Oral SUPPL-11 Perrigo R and D Labeling Approved
Esomeprazole Magnesium
ANDA #207673
Esomeprazole Magnesium Capsule, Delayed Release; Oral SUPPL-3 Dr Reddys Labs Ltd Labeling Approved
Esomeprazole Magnesium
ANDA #207673
Esomeprazole Magnesium Capsule, Delayed Release; Oral SUPPL-3 Dr Reddys Labs Ltd Labeling Approved
Hydrocodone Bitartrate
ANDA #206986
Hydrocodone Bitartrate Capsule, Extended Release; Oral ORIG-1 Alvogen Approved
Kisqali
NDA #209092
Ribociclib Succinate Tablet; Oral SUPPL-3 Novartis Labeling Approved
Kisqali Femara Co-Pack (Copackaged)
NDA #209935
Letrozole; Ribociclib Succinate Tablet, Tablet; Oral SUPPL-6 Novartis Labeling Approved
Lamotrigine
ANDA #078691
Lamotrigine Tablet; Oral SUPPL-5 Lupin Ltd Labeling Approved
Lamotrigine
ANDA #078691
Lamotrigine Tablet; Oral SUPPL-6 Lupin Ltd Labeling Approved
Lamotrigine
ANDA #078691
Lamotrigine Tablet; Oral SUPPL-7 Lupin Ltd Labeling Approved
Lamotrigine
ANDA #078691
Lamotrigine Tablet; Oral SUPPL-8 Lupin Ltd Labeling Approved
Lamotrigine
ANDA #078691
Lamotrigine Tablet; Oral SUPPL-5 Lupin Ltd Labeling Approved
Lamotrigine
ANDA #078691
Lamotrigine Tablet; Oral SUPPL-6 Lupin Ltd Labeling Approved
Lamotrigine
ANDA #078691
Lamotrigine Tablet; Oral SUPPL-7 Lupin Ltd Labeling Approved
Lamotrigine
ANDA #078691
Lamotrigine Tablet; Oral SUPPL-8 Lupin Ltd Labeling Approved
Montelukast Sodium
ANDA #090655
Montelukast Sodium Tablet; Oral SUPPL-3 Hikma Labeling Approved
Montelukast Sodium
ANDA #090655
Montelukast Sodium Tablet; Oral SUPPL-4 Hikma Labeling Approved
Montelukast Sodium
ANDA #090655
Montelukast Sodium Tablet; Oral SUPPL-5 Hikma Labeling Approved
Montelukast Sodium
ANDA #091128
Montelukast Sodium Tablet, Chewable; Oral SUPPL-3 Hikma Labeling Approved
Montelukast Sodium
ANDA #091128
Montelukast Sodium Tablet, Chewable; Oral SUPPL-4 Hikma Labeling Approved
Montelukast Sodium
ANDA #091128
Montelukast Sodium Tablet, Chewable; Oral SUPPL-5 Hikma Labeling Approved
Risperidone
ANDA #078269
Risperidone Tablet; Oral SUPPL-12 Rising Labeling Approved
Risperidone
ANDA #078269
Risperidone Tablet; Oral SUPPL-13 Rising Labeling Approved
Risperidone
ANDA #078269
Risperidone Tablet; Oral SUPPL-14 Rising Labeling Approved
Spectazole
NDA #018751
Econazole Nitrate Cream; Topical SUPPL-25 Alvogen Labeling Approved
Tepezza
BLA #761143
Teprotumumab-Trbw Injectable; Injection ORIG-1 Horizon Therapeutics Ireland Type 1 - New Molecular Entity Approved
Tobramycin
ANDA #201422
Tobramycin Solution; Inhalation SUPPL-1 Akorn Inc Labeling Approved
Tobramycin
ANDA #201422
Tobramycin Solution; Inhalation SUPPL-3 Akorn Inc Labeling Approved
Tobramycin
ANDA #201422
Tobramycin Solution; Inhalation SUPPL-4 Akorn Inc Labeling Approved

January 17, 2020

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Benlysta
BLA #125370
Belimumab Injectable; Injection SUPPL-68 Human Genome Sciences Inc. Efficacy Approved
Benlysta
BLA #761043
Belimumab Injectable; Injection SUPPL-8 Glaxosmithkline Llc Labeling Approved
Chlorpromazine Hydrochloride
ANDA #213368
Chlorpromazine Hydrochloride Tablet; Oral ORIG-1 Zydus Approved
Erythromycin Ethylsuccinate
ANDA #061904
Erythromycin Ethylsuccinate Tablet; Oral SUPPL-23 Arbor Pharms Llc Labeling Approved
Erythromycin Ethylsuccinate
ANDA #061904
Erythromycin Ethylsuccinate Tablet; Oral SUPPL-25 Arbor Pharms Llc Labeling Approved
Fenofibrate
ANDA #213252
Fenofibrate Tablet; Oral ORIG-1 Alembic Pharms Ltd Approved
Lamotrigine
ANDA #090170
Lamotrigine Tablet; Oral SUPPL-15 Unichem Labs Ltd Labeling Approved
Lamotrigine
ANDA #090170
Lamotrigine Tablet; Oral SUPPL-15 Unichem Labs Ltd Labeling Approved
Lamotrigine
ANDA #090170
Lamotrigine Tablet; Oral SUPPL-21 Unichem Labs Ltd Labeling Approved
Lamotrigine
ANDA #090170
Lamotrigine Tablet; Oral SUPPL-23 Unichem Labs Ltd Labeling Approved
Lamotrigine
ANDA #090170
Lamotrigine Tablet; Oral SUPPL-15 Unichem Labs Ltd Labeling Approved
Lamotrigine
ANDA #090170
Lamotrigine Tablet; Oral SUPPL-21 Unichem Labs Ltd Labeling Approved
Lamotrigine
ANDA #090170
Lamotrigine Tablet; Oral SUPPL-23 Unichem Labs Ltd Labeling Approved
Lamotrigine
ANDA #090170
Lamotrigine Tablet; Oral SUPPL-25 Unichem Labs Ltd Labeling Approved
Naloxone Hydrochloride
ANDA #211286
Naloxone Hydrochloride Injectable; Injection ORIG-1 Par Sterile Products Approved
Omeprazole and Clarithromycin and Amoxicillin
NDA #050824
Amoxicillin; Clarithromycin; Omeprazole Capsule, Tablet, Capsule, Delayed Release; Oral SUPPL-7 Cumberland Pharms Labeling Approved

January 16, 2020

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Amantadine
ANDA #211493
Amantadine Unknown ORIG-1 Sandoz Inc Tentative Approval
Bupropion Hydrochloride
ANDA #208606
Bupropion Hydrochloride Unknown ORIG-1 Cadila Pharms Ltd Approved
Calomist
NDA #022102
Cyanocobalamin Spray, Metered; Nasal SUPPL-4 Par Pharm Labeling Approved
Ixifi
BLA #761072
Infliximab-Qbtx Injectable; Injection SUPPL-6 Pfizer Inc Efficacy Approved
Monoferric
NDA #208171
Ferric Derisomaltose Injectable; Injection ORIG-1 Pharmacosmos As Type 5 - New Formulation or New Manufacturer Approved
Ozempic
NDA #209637
Semaglutide Solution; Subcutaneous SUPPL-3 Novo Efficacy Approved
Perjeta
BLA #125409
Pertuzumab Vial; Single-Use SUPPL-124 Genentech Efficacy Approved
Phenylephrine Hydrochloride
ANDA #209967
Phenylephrine Hydrochloride Solution; Intravenous ORIG-1 Riconpharma Llc Approved
Rybelsus
NDA #213051
Semaglutide Tablet; Oral SUPPL-1 Novo Labeling Approved
Rybelsus
NDA #213051
Semaglutide Tablet; Oral SUPPL-1 Novo Labeling Approved
Rybelsus
NDA #213182
Semaglutide Tablet; Oral ORIG-1 Novo Nordisk Inc Type 9 - New Indication Submitted as Distinct NDA, Consolidated with Original NDA after Approval Approved
Tygacil
NDA #021821
Tigecycline Powder; Intravenous SUPPL-48 Pf Prism Cv Labeling Approved

January 15, 2020

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Bosentan
ANDA #205173
Bosentan Tablet; Oral ORIG-1 Mylan Approved
Bosutinib
ANDA #209624
Bosutinib Unknown ORIG-1 Msn Laboratories Private Ltd Tentative Approval
Dapagliflozin
ANDA #211470
Dapagliflozin Unknown ORIG-1 Biocon Pharma Ltd Tentative Approval
Esomeprazole Magnesium
ANDA #209339
Esomeprazole Magnesium Capsule, Delayed Release; Oral SUPPL-6 Aurobindo Pharma Ltd Labeling Approved
Esomeprazole Magnesium
ANDA #209339
Esomeprazole Magnesium Capsule, Delayed Release; Oral SUPPL-2 Aurobindo Pharma Ltd Labeling Approved
Esomeprazole Magnesium
ANDA #209339
Esomeprazole Magnesium Capsule, Delayed Release; Oral SUPPL-6 Aurobindo Pharma Ltd Labeling Approved
Lamotrigine
ANDA #090607
Lamotrigine Tablet; Oral SUPPL-17 Alembic Pharms Ltd Labeling Approved
Lamotrigine
ANDA #090607
Lamotrigine Tablet; Oral SUPPL-19 Alembic Pharms Ltd Labeling Approved
Lamotrigine
ANDA #090607
Lamotrigine Tablet; Oral SUPPL-17 Alembic Pharms Ltd Labeling Approved
Lamotrigine
ANDA #090607
Lamotrigine Tablet; Oral SUPPL-17 Alembic Pharms Ltd Labeling Approved
Lamotrigine
ANDA #090607
Lamotrigine Tablet; Oral SUPPL-19 Alembic Pharms Ltd Labeling Approved
Lamotrigine
ANDA #090607
Lamotrigine Tablet; Oral SUPPL-20 Alembic Pharms Ltd Labeling Approved
Loratadine
ANDA #211926
Loratadine Capsule; Oral ORIG-1 Strides Pharma Approved
Signifor
NDA #200677
Pasireotide Diaspartate Solution; Subcutaneous SUPPL-6 Novartis Efficacy Approved
Sildenafil Citrate
ANDA #202025
Sildenafil Citrate Tablet; Oral SUPPL-3 Amneal Pharms Labeling Approved
Sildenafil Citrate
ANDA #202025
Sildenafil Citrate Tablet; Oral SUPPL-3 Amneal Pharms Labeling Approved
Sildenafil Citrate
ANDA #202025
Sildenafil Citrate Tablet; Oral SUPPL-4 Amneal Pharms Labeling Approved
Sildenafil Citrate
ANDA #202025
Sildenafil Citrate Tablet; Oral SUPPL-3 Amneal Pharms Labeling Approved
Sildenafil Citrate
ANDA #202025
Sildenafil Citrate Tablet; Oral SUPPL-4 Amneal Pharms Labeling Approved
Succinylcholine Chloride
ANDA #211589
Succinylcholine Chloride Injectable; Injection ORIG-1 Somerset Theraps Llc Approved

January 22, 2020

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Afinitor
NDA #022334
Everolimus Tablet; Oral SUPPL-45 Novartis Labeling Approved
Afinitor Disperz
NDA #203985
Everolimus Tablet, For Suspension; Oral SUPPL-17 Novartis Pharm Labeling Approved
Tetrabenazine
ANDA #213316
Tetrabenazine Tablet; Oral ORIG-1 Piramal Hlthcare Uk Approved

January 21, 2020

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Bimatoprost
ANDA #210515
Bimatoprost Solution/Drops; Topical ORIG-1 Alembic Pharms Ltd Approved
Desipramine Hydrochloride
ANDA #071588
Desipramine Hydrochloride Tablet; Oral SUPPL-31 Actavis Totowa Labeling Approved
Desipramine Hydrochloride
ANDA #071588
Desipramine Hydrochloride Tablet; Oral SUPPL-31 Actavis Totowa Labeling Approved
Desipramine Hydrochloride
ANDA #071601
Desipramine Hydrochloride Tablet; Oral SUPPL-32 Actavis Totowa Labeling Approved
Desipramine Hydrochloride
ANDA #071601
Desipramine Hydrochloride Tablet; Oral SUPPL-32 Actavis Totowa Labeling Approved
Desipramine Hydrochloride
ANDA #071602
Desipramine Hydrochloride Tablet; Oral SUPPL-29 Actavis Totowa Labeling Approved
Desipramine Hydrochloride
ANDA #071602
Desipramine Hydrochloride Tablet; Oral SUPPL-29 Actavis Totowa Labeling Approved
Desipramine Hydrochloride
ANDA #071766
Desipramine Hydrochloride Tablet; Oral SUPPL-30 Actavis Totowa Labeling Approved
Desipramine Hydrochloride
ANDA #071766
Desipramine Hydrochloride Tablet; Oral SUPPL-30 Actavis Totowa Labeling Approved
Desipramine Hydrochloride
ANDA #074430
Desipramine Hydrochloride Tablet; Oral SUPPL-19 Actavis Totowa Labeling Approved
Desipramine Hydrochloride
ANDA #074430
Desipramine Hydrochloride Tablet; Oral SUPPL-19 Actavis Totowa Labeling Approved
Divalproex Sodium
ANDA #078979
Divalproex Sodium Capsule, Delayed Rel Pellets; Oral SUPPL-18 Dr Reddys Labs Ltd Labeling Approved
Divalproex Sodium
ANDA #078979
Divalproex Sodium Capsule, Delayed Rel Pellets; Oral SUPPL-18 Dr Reddys Labs Ltd Labeling Approved
Divalproex Sodium
ANDA #078979
Divalproex Sodium Capsule, Delayed Rel Pellets; Oral SUPPL-19 Dr Reddys Labs Ltd Labeling Approved
Divalproex Sodium
ANDA #078979
Divalproex Sodium Capsule, Delayed Rel Pellets; Oral SUPPL-20 Dr Reddys Labs Ltd Labeling Approved
Divalproex Sodium
ANDA #078979
Divalproex Sodium Capsule, Delayed Rel Pellets; Oral SUPPL-21 Dr Reddys Labs Ltd Labeling Approved
Divalproex Sodium
ANDA #078979
Divalproex Sodium Capsule, Delayed Rel Pellets; Oral SUPPL-22 Dr Reddys Labs Ltd Labeling Approved
Divalproex Sodium
ANDA #078979
Divalproex Sodium Capsule, Delayed Rel Pellets; Oral SUPPL-18 Dr Reddys Labs Ltd Labeling Approved
Divalproex Sodium
ANDA #078979
Divalproex Sodium Capsule, Delayed Rel Pellets; Oral SUPPL-19 Dr Reddys Labs Ltd Labeling Approved
Divalproex Sodium
ANDA #078979
Divalproex Sodium Capsule, Delayed Rel Pellets; Oral SUPPL-20 Dr Reddys Labs Ltd Labeling Approved
Divalproex Sodium
ANDA #078979
Divalproex Sodium Capsule, Delayed Rel Pellets; Oral SUPPL-21 Dr Reddys Labs Ltd Labeling Approved
Divalproex Sodium
ANDA #078979
Divalproex Sodium Capsule, Delayed Rel Pellets; Oral SUPPL-22 Dr Reddys Labs Ltd Labeling Approved
Esomeprazole Magnesium
ANDA #207193
Esomeprazole Magnesium Capsule, Delayed Release; Oral SUPPL-3 Perrigo R and D Labeling Approved
Esomeprazole Magnesium
ANDA #207193
Esomeprazole Magnesium Capsule, Delayed Release; Oral SUPPL-11 Perrigo R and D Labeling Approved
Esomeprazole Magnesium
ANDA #207193
Esomeprazole Magnesium Capsule, Delayed Release; Oral SUPPL-3 Perrigo R and D Labeling Approved
Esomeprazole Magnesium
ANDA #207193
Esomeprazole Magnesium Capsule, Delayed Release; Oral SUPPL-11 Perrigo R and D Labeling Approved
Esomeprazole Magnesium
ANDA #207673
Esomeprazole Magnesium Capsule, Delayed Release; Oral SUPPL-3 Dr Reddys Labs Ltd Labeling Approved
Esomeprazole Magnesium
ANDA #207673
Esomeprazole Magnesium Capsule, Delayed Release; Oral SUPPL-3 Dr Reddys Labs Ltd Labeling Approved
Hydrocodone Bitartrate
ANDA #206986
Hydrocodone Bitartrate Capsule, Extended Release; Oral ORIG-1 Alvogen Approved
Kisqali
NDA #209092
Ribociclib Succinate Tablet; Oral SUPPL-3 Novartis Labeling Approved
Kisqali Femara Co-Pack (Copackaged)
NDA #209935
Letrozole; Ribociclib Succinate Tablet, Tablet; Oral SUPPL-6 Novartis Labeling Approved
Lamotrigine
ANDA #078691
Lamotrigine Tablet; Oral SUPPL-5 Lupin Ltd Labeling Approved
Lamotrigine
ANDA #078691
Lamotrigine Tablet; Oral SUPPL-6 Lupin Ltd Labeling Approved
Lamotrigine
ANDA #078691
Lamotrigine Tablet; Oral SUPPL-7 Lupin Ltd Labeling Approved
Lamotrigine
ANDA #078691
Lamotrigine Tablet; Oral SUPPL-8 Lupin Ltd Labeling Approved
Lamotrigine
ANDA #078691
Lamotrigine Tablet; Oral SUPPL-5 Lupin Ltd Labeling Approved
Lamotrigine
ANDA #078691
Lamotrigine Tablet; Oral SUPPL-6 Lupin Ltd Labeling Approved
Lamotrigine
ANDA #078691
Lamotrigine Tablet; Oral SUPPL-7 Lupin Ltd Labeling Approved
Lamotrigine
ANDA #078691
Lamotrigine Tablet; Oral SUPPL-8 Lupin Ltd Labeling Approved
Montelukast Sodium
ANDA #090655
Montelukast Sodium Tablet; Oral SUPPL-3 Hikma Labeling Approved
Montelukast Sodium
ANDA #090655
Montelukast Sodium Tablet; Oral SUPPL-4 Hikma Labeling Approved
Montelukast Sodium
ANDA #090655
Montelukast Sodium Tablet; Oral SUPPL-5 Hikma Labeling Approved
Montelukast Sodium
ANDA #091128
Montelukast Sodium Tablet, Chewable; Oral SUPPL-3 Hikma Labeling Approved
Montelukast Sodium
ANDA #091128
Montelukast Sodium Tablet, Chewable; Oral SUPPL-4 Hikma Labeling Approved
Montelukast Sodium
ANDA #091128
Montelukast Sodium Tablet, Chewable; Oral SUPPL-5 Hikma Labeling Approved
Risperidone
ANDA #078269
Risperidone Tablet; Oral SUPPL-12 Rising Labeling Approved
Risperidone
ANDA #078269
Risperidone Tablet; Oral SUPPL-13 Rising Labeling Approved
Risperidone
ANDA #078269
Risperidone Tablet; Oral SUPPL-14 Rising Labeling Approved
Spectazole
NDA #018751
Econazole Nitrate Cream; Topical SUPPL-25 Alvogen Labeling Approved
Tepezza
BLA #761143
Teprotumumab-Trbw Injectable; Injection ORIG-1 Horizon Therapeutics Ireland Type 1 - New Molecular Entity Approved
Tobramycin
ANDA #201422
Tobramycin Solution; Inhalation SUPPL-1 Akorn Inc Labeling Approved
Tobramycin
ANDA #201422
Tobramycin Solution; Inhalation SUPPL-3 Akorn Inc Labeling Approved
Tobramycin
ANDA #201422
Tobramycin Solution; Inhalation SUPPL-4 Akorn Inc Labeling Approved

January 17, 2020

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Benlysta
BLA #125370
Belimumab Injectable; Injection SUPPL-68 Human Genome Sciences Inc. Efficacy Approved
Benlysta
BLA #761043
Belimumab Injectable; Injection SUPPL-8 Glaxosmithkline Llc Labeling Approved
Chlorpromazine Hydrochloride
ANDA #213368
Chlorpromazine Hydrochloride Tablet; Oral ORIG-1 Zydus Approved
Erythromycin Ethylsuccinate
ANDA #061904
Erythromycin Ethylsuccinate Tablet; Oral SUPPL-23 Arbor Pharms Llc Labeling Approved
Erythromycin Ethylsuccinate
ANDA #061904
Erythromycin Ethylsuccinate Tablet; Oral SUPPL-25 Arbor Pharms Llc Labeling Approved
Fenofibrate
ANDA #213252
Fenofibrate Tablet; Oral ORIG-1 Alembic Pharms Ltd Approved
Lamotrigine
ANDA #090170
Lamotrigine Tablet; Oral SUPPL-15 Unichem Labs Ltd Labeling Approved
Lamotrigine
ANDA #090170
Lamotrigine Tablet; Oral SUPPL-15 Unichem Labs Ltd Labeling Approved
Lamotrigine
ANDA #090170
Lamotrigine Tablet; Oral SUPPL-21 Unichem Labs Ltd Labeling Approved
Lamotrigine
ANDA #090170
Lamotrigine Tablet; Oral SUPPL-23 Unichem Labs Ltd Labeling Approved
Lamotrigine
ANDA #090170
Lamotrigine Tablet; Oral SUPPL-15 Unichem Labs Ltd Labeling Approved
Lamotrigine
ANDA #090170
Lamotrigine Tablet; Oral SUPPL-21 Unichem Labs Ltd Labeling Approved
Lamotrigine
ANDA #090170
Lamotrigine Tablet; Oral SUPPL-23 Unichem Labs Ltd Labeling Approved
Lamotrigine
ANDA #090170
Lamotrigine Tablet; Oral SUPPL-25 Unichem Labs Ltd Labeling Approved
Naloxone Hydrochloride
ANDA #211286
Naloxone Hydrochloride Injectable; Injection ORIG-1 Par Sterile Products Approved
Omeprazole and Clarithromycin and Amoxicillin
NDA #050824
Amoxicillin; Clarithromycin; Omeprazole Capsule, Tablet, Capsule, Delayed Release; Oral SUPPL-7 Cumberland Pharms Labeling Approved

January 16, 2020

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Amantadine
ANDA #211493
Amantadine Unknown ORIG-1 Sandoz Inc Tentative Approval
Bupropion Hydrochloride
ANDA #208606
Bupropion Hydrochloride Unknown ORIG-1 Cadila Pharms Ltd Approved
Calomist
NDA #022102
Cyanocobalamin Spray, Metered; Nasal SUPPL-4 Par Pharm Labeling Approved
Ixifi
BLA #761072
Infliximab-Qbtx Injectable; Injection SUPPL-6 Pfizer Inc Efficacy Approved
Monoferric
NDA #208171
Ferric Derisomaltose Injectable; Injection ORIG-1 Pharmacosmos As Type 5 - New Formulation or New Manufacturer Approved
Ozempic
NDA #209637
Semaglutide Solution; Subcutaneous SUPPL-3 Novo Efficacy Approved
Perjeta
BLA #125409
Pertuzumab Vial; Single-Use SUPPL-124 Genentech Efficacy Approved
Phenylephrine Hydrochloride
ANDA #209967
Phenylephrine Hydrochloride Solution; Intravenous ORIG-1 Riconpharma Llc Approved
Rybelsus
NDA #213051
Semaglutide Tablet; Oral SUPPL-1 Novo Labeling Approved
Rybelsus
NDA #213051
Semaglutide Tablet; Oral SUPPL-1 Novo Labeling Approved
Rybelsus
NDA #213182
Semaglutide Tablet; Oral ORIG-1 Novo Nordisk Inc Type 9 - New Indication Submitted as Distinct NDA, Consolidated with Original NDA after Approval Approved
Tygacil
NDA #021821
Tigecycline Powder; Intravenous SUPPL-48 Pf Prism Cv Labeling Approved

January 15, 2020

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Bosentan
ANDA #205173
Bosentan Tablet; Oral ORIG-1 Mylan Approved
Bosutinib
ANDA #209624
Bosutinib Unknown ORIG-1 Msn Laboratories Private Ltd Tentative Approval
Dapagliflozin
ANDA #211470
Dapagliflozin Unknown ORIG-1 Biocon Pharma Ltd Tentative Approval
Esomeprazole Magnesium
ANDA #209339
Esomeprazole Magnesium Capsule, Delayed Release; Oral SUPPL-6 Aurobindo Pharma Ltd Labeling Approved
Esomeprazole Magnesium
ANDA #209339
Esomeprazole Magnesium Capsule, Delayed Release; Oral SUPPL-2 Aurobindo Pharma Ltd Labeling Approved
Esomeprazole Magnesium
ANDA #209339
Esomeprazole Magnesium Capsule, Delayed Release; Oral SUPPL-6 Aurobindo Pharma Ltd Labeling Approved
Lamotrigine
ANDA #090607
Lamotrigine Tablet; Oral SUPPL-17 Alembic Pharms Ltd Labeling Approved
Lamotrigine
ANDA #090607
Lamotrigine Tablet; Oral SUPPL-19 Alembic Pharms Ltd Labeling Approved
Lamotrigine
ANDA #090607
Lamotrigine Tablet; Oral SUPPL-17 Alembic Pharms Ltd Labeling Approved
Lamotrigine
ANDA #090607
Lamotrigine Tablet; Oral SUPPL-17 Alembic Pharms Ltd Labeling Approved
Lamotrigine
ANDA #090607
Lamotrigine Tablet; Oral SUPPL-19 Alembic Pharms Ltd Labeling Approved
Lamotrigine
ANDA #090607
Lamotrigine Tablet; Oral SUPPL-20 Alembic Pharms Ltd Labeling Approved
Loratadine
ANDA #211926
Loratadine Capsule; Oral ORIG-1 Strides Pharma Approved
Signifor
NDA #200677
Pasireotide Diaspartate Solution; Subcutaneous SUPPL-6 Novartis Efficacy Approved
Sildenafil Citrate
ANDA #202025
Sildenafil Citrate Tablet; Oral SUPPL-3 Amneal Pharms Labeling Approved
Sildenafil Citrate
ANDA #202025
Sildenafil Citrate Tablet; Oral SUPPL-3 Amneal Pharms Labeling Approved
Sildenafil Citrate
ANDA #202025
Sildenafil Citrate Tablet; Oral SUPPL-4 Amneal Pharms Labeling Approved
Sildenafil Citrate
ANDA #202025
Sildenafil Citrate Tablet; Oral SUPPL-3 Amneal Pharms Labeling Approved
Sildenafil Citrate
ANDA #202025
Sildenafil Citrate Tablet; Oral SUPPL-4 Amneal Pharms Labeling Approved
Succinylcholine Chloride
ANDA #211589
Succinylcholine Chloride Injectable; Injection ORIG-1 Somerset Theraps Llc Approved

January 14, 2020

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Empagliflozin
ANDA #212355
Empagliflozin Unknown ORIG-1 Alembic Ltd Tentative Approval
Emtricitabine and Tenofovir Disoproxil Fumarate
ANDA #090513
Emtricitabine; Tenofovir Disoproxil Fumarate Tablet; Oral SUPPL-10 Aurobindo Pharma Ltd Labeling Approved
Emtricitabine and Tenofovir Disoproxil Fumarate
ANDA #090513
Emtricitabine; Tenofovir Disoproxil Fumarate Tablet; Oral SUPPL-10 Aurobindo Pharma Ltd Labeling Approved
Jakafi
NDA #202192
Ruxolitinib Phosphate Tablet; Oral SUPPL-19 Incyte Corp Labeling Approved
Potassium Citrate
ANDA #212779
Potassium Citrate Tablet, Extended Release; Oral ORIG-1 Ani Pharms Inc Approved
Tranexamic Acid
ANDA #209860
Tranexamic Acid Injectable; Injection ORIG-1 Apotex Approved

January 13, 2020

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Azithromycin
ANDA #065246
Azithromycin For Suspension; Oral SUPPL-25 Pliva Labeling Approved
Azithromycin
ANDA #065246
Azithromycin For Suspension; Oral SUPPL-26 Pliva Labeling Approved
Azithromycin
ANDA #065246
Azithromycin For Suspension; Oral SUPPL-25 Pliva Labeling Approved
Azithromycin
ANDA #065246
Azithromycin For Suspension; Oral SUPPL-26 Pliva Labeling Approved
Azithromycin
ANDA #211147
Azithromycin For Suspension; Oral SUPPL-3 Zydus Labeling Approved
Azithromycin
ANDA #211147
Azithromycin For Suspension; Oral SUPPL-3 Zydus Labeling Approved
Bortezomib
ANDA #212825
Bortezomib Unknown ORIG-1 Eugia Pharma Tentative Approval
Levocetirizine Dihydrochloride
ANDA #202673
Levocetirizine Dihydrochloride Solution; Oral SUPPL-3 Taro Pharm Inds Ltd Labeling Approved
Levocetirizine Dihydrochloride
ANDA #202673
Levocetirizine Dihydrochloride Solution; Oral SUPPL-4 Taro Pharm Inds Ltd Labeling Approved
Levocetirizine Dihydrochloride
ANDA #202673
Levocetirizine Dihydrochloride Solution; Oral SUPPL-5 Taro Pharm Inds Ltd Labeling Approved
Levocetirizine Dihydrochloride
ANDA #202673
Levocetirizine Dihydrochloride Solution; Oral SUPPL-6 Taro Pharm Inds Ltd Labeling Approved
Levocetirizine Dihydrochloride
ANDA #202673
Levocetirizine Dihydrochloride Solution; Oral SUPPL-7 Taro Pharm Inds Ltd Labeling Approved
Licart
NDA #206976
Diclofenac Epolamine System; Topical SUPPL-3 Ibsa Inst Bio Labeling Approved
Tizanidine Hydrochloride
ANDA #213223
Tizanidine Hydrochloride Capsule; Oral ORIG-1 Alembic Pharms Ltd Approved
Topotecan Hydrochloride
ANDA #090620
Topotecan Hydrochloride Injectable; Injection SUPPL-8 Actavis Totowa Labeling Approved
Topotecan Hydrochloride
ANDA #090620
Topotecan Hydrochloride Injectable; Injection SUPPL-9 Actavis Totowa Labeling Approved
Valchlor
NDA #202317
Mechlorethamine Hydrochloride Gel; Topical SUPPL-9 Helsinn Labeling Approved
Valganciclovir Hydrochloride
ANDA #212890
Valganciclovir Hydrochloride For Solution; Oral ORIG-1 Ajanta Pharma Ltd Approved
Vyxeos
NDA #209401
Cytarabine; Daunorubicin Powder; Intravenous SUPPL-2 Celator Pharms Labeling Approved
Zolmitriptan
ANDA #201779
Zolmitriptan Tablet; Oral SUPPL-2 Glenmark Generics Labeling Approved
Zolmitriptan
ANDA #201779
Zolmitriptan Tablet; Oral SUPPL-2 Glenmark Generics Labeling Approved

January 10, 2020

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Atrovent Hfa
NDA #021527
Ipratropium Bromide Aerosol, Metered; Inhalation SUPPL-33 Boehringer Ingelheim Labeling Approved
Iclusig
NDA #203469
Ponatinib Hydrochloride Tablet; Oral SUPPL-31 Ariad Labeling Approved
Neuraceq
NDA #204677
Florbetaben F-18 Solution; Intravenous SUPPL-19 Life Molecular Labeling Approved
Numbrino
NDA #209575
Cocaine Hydrochloride Solution; Nasal ORIG-1 Cody Laboratories, Inc. Type 7 - Drug Already Marketed without Approved NDA Approved
Ocrevus
BLA #761053
Ocrelizumab Injectable; Injection SUPPL-20 Genentech Inc Labeling Approved
Pregabalin
ANDA #212280
Pregabalin Capsule; Oral ORIG-1 Cipla Approved
Pyridostigmine Bromide
ANDA #212702
Pyridostigmine Bromide Syrup; Oral ORIG-1 Amneal Pharms Llc Approved
Thiotepa
ANDA #208242
Thiotepa Injectable; Injection ORIG-1 Sti Pharma Llc Approved
Valtoco
NDA #211635
Diazepam Spray; Nasal ORIG-1 Neurelis Inc Type 3 - New Dosage Form Approved
Vilazodone Hydrochloride
ANDA #208202
Vilazodone Hydrochloride Tablet; Oral ORIG-1 Alembic Pharms Ltd Approved
Vizamyl
NDA #203137
Flutemetamol F-18 Injectable; Intravenous SUPPL-13 Ge Healthcare Labeling Approved

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