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.

July 2, 2020

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Byfavo
NDA #212295
Remimazolam Injectable; Injection ORIG-1 Cosmo Technologies Ltd Type 1 - New Molecular Entity and Type 4 - New Combination Approved

July 1, 2020

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Atorvastatin Calcium
ANDA #205519
Atorvastatin Calcium Tablet; Oral SUPPL-21 Sciegen Pharms Inc Labeling Approved
Atorvastatin Calcium
ANDA #205519
Atorvastatin Calcium Tablet; Oral SUPPL-21 Sciegen Pharms Inc Labeling Approved
Bumetanide
ANDA #074332
Bumetanide Injectable; Injection SUPPL-15 Hospira Labeling Approved
Doxepin Hydrochloride
ANDA #213063
Doxepin Hydrochloride Capsule; Oral ORIG-1 Taro Pharm Inds Ltd Approved
Furosemide
ANDA #213902
Furosemide Injectable; Injection ORIG-1 Gland Pharma Ltd Approved
Natpara
BLA #125511
Parathyroid Hormone Injectable; Injection SUPPL-20 Nps Pharms Inc Labeling Approved
Pradaxa
NDA #022512
Dabigatran Etexilate Mesylate Capsule; Oral SUPPL-39 Boehringer Ingelheim Labeling Approved

June 30, 2020

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Aveed
NDA #022219
Testosterone Undecanoate Injectable; Intramuscular SUPPL-14 Endo Pharms Inc Labeling Approved
Bavencio
BLA #761049
Avelumab Injectable; Injection SUPPL-9 Emd Serono Inc Efficacy Approved
Bupropion Hydrochloride
ANDA #206556
Bupropion Hydrochloride Tablet, Extended Release; Oral SUPPL-14 Invagen Pharms Labeling Approved
Bupropion Hydrochloride
ANDA #206556
Bupropion Hydrochloride Tablet, Extended Release; Oral SUPPL-14 Invagen Pharms Labeling Approved
Bupropion Hydrochloride
ANDA #208652
Bupropion Hydrochloride Tablet, Extended Release; Oral SUPPL-5 Sinotherapeutics Inc Labeling Approved
Bupropion Hydrochloride
ANDA #208652
Bupropion Hydrochloride Tablet, Extended Release; Oral SUPPL-5 Sinotherapeutics Inc Labeling Approved
Bupropion Hydrochloride
ANDA #211020
Bupropion Hydrochloride Tablet, Extended Release; Oral SUPPL-4 Graviti Pharms Labeling Approved
Dojolvi
NDA #213687
Triheptanoin Liquid; Oral ORIG-1 Ultragenyx Pharm Inc Type 1 - New Molecular Entity Approved
Doxycycline Hyclate
ANDA #211744
Doxycycline Hyclate Tablet; Oral ORIG-1 Alembic Pharms Ltd Approved
Fortesta
NDA #021463
Testosterone Gel, Metered; Transdermal SUPPL-25 Endo Pharms Labeling Approved
Pantoprazole Sodium
ANDA #213725
Pantoprazole Sodium For Suspension, Delayed Release; Oral ORIG-1 Sun Pharm Approved
Retacrit
BLA #125545
Epoetin Alfa-Epbx Injectable; Injection SUPPL-5 Hospira Inc Efficacy Approved

June 29, 2020

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Campath
BLA #103948
Alemtuzumab Vial; Intravenous SUPPL-5176 Genzyme Labeling Approved
Dacogen
NDA #021790
Decitabine Injectable; Intravenous SUPPL-25 Otsuka Pharm Co Ltd Labeling Approved
Darzalex
BLA #761036
Daratumumab Injectable; Injection SUPPL-26 Janssen Biotech Efficacy Approved
Fingolimod Hydrochloride
ANDA #207971
Fingolimod Hydrochloride Capsule; Oral ORIG-1 Strides Pharma Approved
Granisetron Hydrochloride
ANDA #202648
Granisetron Hydrochloride Injectable; Injection ORIG-1 Yung Shin Pharm Approved
Keytruda
BLA #125514
Pembrolizumab Powder, For Injection Solution, Lyophilized Powder SUPPL-84 Merck Sharp Dohme Efficacy Approved
Lemtrada
BLA #103948
Alemtuzumab Injectable; Injection SUPPL-5176 Genzyme Labeling Approved
Nevirapine
ANDA #078644
Nevirapine Tablet; Oral SUPPL-3 Prinston Inc Labeling Approved
Nevirapine
ANDA #078644
Nevirapine Tablet; Oral SUPPL-3 Prinston Inc Labeling Approved
Nevirapine
ANDA #078644
Nevirapine Tablet; Oral SUPPL-5 Prinston Inc Labeling Approved
Nevirapine
ANDA #078644
Nevirapine Tablet; Oral SUPPL-3 Prinston Inc Labeling Approved
Nevirapine
ANDA #078644
Nevirapine Tablet; Oral SUPPL-5 Prinston Inc Labeling Approved
Nitrogen, Nf
NDA #214858
Nitrogen Gas; Inhalation ORIG-1 Air Liquide Canada Inc Approved
Phesgo
BLA #761170
Pertuzumab;Trastuzumab;Hyaluronidase-Zzxf Injectable; Intravenous, Subcutaneous ORIG-1 Genentech Inc Type 4 - New Combination Approved
Potassium Citrate
ANDA #212799
Potassium Citrate Tablet, Extended Release; Oral ORIG-1 Bionpharma Inc Approved
Yervoy
BLA #125377
Ipilimumab Injectable; Injection SUPPL-106 Bristol Myers Squibb Labeling Approved

June 26, 2020

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Cytarabine
ANDA #206189
Cytarabine Injectable; Injection ORIG-1 Hong Kong Approved
Doxorubicin Hydrochloride (Liposomal)
ANDA #203263
Doxorubicin Hydrochloride Injectable, Liposomal; Injection SUPPL-27 Sun Pharm Labeling Approved
Doxorubicin Hydrochloride (Liposomal)
ANDA #203263
Doxorubicin Hydrochloride Injectable, Liposomal; Injection SUPPL-27 Sun Pharm Labeling Approved
Doxorubicin Hydrochloride (Liposomal)
ANDA #208657
Doxorubicin Hydrochloride Injectable, Liposomal; Injection SUPPL-4 Dr Reddys Labs Ltd Labeling Approved
Fragmin
NDA #020287
Dalteparin Sodium Injectable; Injection SUPPL-74 Pfizer Inc Labeling Approved
Fragmin
NDA #020287
Dalteparin Sodium Injectable; Injection SUPPL-75 Pfizer Inc Labeling Approved
Fragmin
NDA #020287
Dalteparin Sodium Injectable; Subcutaneous SUPPL-74 Pfizer Inc Labeling Approved
Fragmin
NDA #020287
Dalteparin Sodium Injectable; Subcutaneous SUPPL-75 Pfizer Inc Labeling Approved
Lialda
NDA #022000
Mesalamine Tablet, Delayed Release; Oral SUPPL-19 Shire Efficacy Approved
Mycapssa
NDA #208232
Octreotide Capsule, Delayed Release; Oral ORIG-1 Chiasma Inc Type 5 - New Formulation or New Manufacturer Approved

July 2, 2020

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Byfavo
NDA #212295
Remimazolam Injectable; Injection ORIG-1 Cosmo Technologies Ltd Type 1 - New Molecular Entity and Type 4 - New Combination Approved

July 1, 2020

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Atorvastatin Calcium
ANDA #205519
Atorvastatin Calcium Tablet; Oral SUPPL-21 Sciegen Pharms Inc Labeling Approved
Atorvastatin Calcium
ANDA #205519
Atorvastatin Calcium Tablet; Oral SUPPL-21 Sciegen Pharms Inc Labeling Approved
Bumetanide
ANDA #074332
Bumetanide Injectable; Injection SUPPL-15 Hospira Labeling Approved
Doxepin Hydrochloride
ANDA #213063
Doxepin Hydrochloride Capsule; Oral ORIG-1 Taro Pharm Inds Ltd Approved
Furosemide
ANDA #213902
Furosemide Injectable; Injection ORIG-1 Gland Pharma Ltd Approved
Natpara
BLA #125511
Parathyroid Hormone Injectable; Injection SUPPL-20 Nps Pharms Inc Labeling Approved
Pradaxa
NDA #022512
Dabigatran Etexilate Mesylate Capsule; Oral SUPPL-39 Boehringer Ingelheim Labeling Approved

June 30, 2020

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Aveed
NDA #022219
Testosterone Undecanoate Injectable; Intramuscular SUPPL-14 Endo Pharms Inc Labeling Approved
Bavencio
BLA #761049
Avelumab Injectable; Injection SUPPL-9 Emd Serono Inc Efficacy Approved
Bupropion Hydrochloride
ANDA #206556
Bupropion Hydrochloride Tablet, Extended Release; Oral SUPPL-14 Invagen Pharms Labeling Approved
Bupropion Hydrochloride
ANDA #206556
Bupropion Hydrochloride Tablet, Extended Release; Oral SUPPL-14 Invagen Pharms Labeling Approved
Bupropion Hydrochloride
ANDA #208652
Bupropion Hydrochloride Tablet, Extended Release; Oral SUPPL-5 Sinotherapeutics Inc Labeling Approved
Bupropion Hydrochloride
ANDA #208652
Bupropion Hydrochloride Tablet, Extended Release; Oral SUPPL-5 Sinotherapeutics Inc Labeling Approved
Bupropion Hydrochloride
ANDA #211020
Bupropion Hydrochloride Tablet, Extended Release; Oral SUPPL-4 Graviti Pharms Labeling Approved
Dojolvi
NDA #213687
Triheptanoin Liquid; Oral ORIG-1 Ultragenyx Pharm Inc Type 1 - New Molecular Entity Approved
Doxycycline Hyclate
ANDA #211744
Doxycycline Hyclate Tablet; Oral ORIG-1 Alembic Pharms Ltd Approved
Fortesta
NDA #021463
Testosterone Gel, Metered; Transdermal SUPPL-25 Endo Pharms Labeling Approved
Pantoprazole Sodium
ANDA #213725
Pantoprazole Sodium For Suspension, Delayed Release; Oral ORIG-1 Sun Pharm Approved
Retacrit
BLA #125545
Epoetin Alfa-Epbx Injectable; Injection SUPPL-5 Hospira Inc Efficacy Approved

June 29, 2020

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Campath
BLA #103948
Alemtuzumab Vial; Intravenous SUPPL-5176 Genzyme Labeling Approved
Dacogen
NDA #021790
Decitabine Injectable; Intravenous SUPPL-25 Otsuka Pharm Co Ltd Labeling Approved
Darzalex
BLA #761036
Daratumumab Injectable; Injection SUPPL-26 Janssen Biotech Efficacy Approved
Fingolimod Hydrochloride
ANDA #207971
Fingolimod Hydrochloride Capsule; Oral ORIG-1 Strides Pharma Approved
Granisetron Hydrochloride
ANDA #202648
Granisetron Hydrochloride Injectable; Injection ORIG-1 Yung Shin Pharm Approved
Keytruda
BLA #125514
Pembrolizumab Powder, For Injection Solution, Lyophilized Powder SUPPL-84 Merck Sharp Dohme Efficacy Approved
Lemtrada
BLA #103948
Alemtuzumab Injectable; Injection SUPPL-5176 Genzyme Labeling Approved
Nevirapine
ANDA #078644
Nevirapine Tablet; Oral SUPPL-3 Prinston Inc Labeling Approved
Nevirapine
ANDA #078644
Nevirapine Tablet; Oral SUPPL-3 Prinston Inc Labeling Approved
Nevirapine
ANDA #078644
Nevirapine Tablet; Oral SUPPL-5 Prinston Inc Labeling Approved
Nevirapine
ANDA #078644
Nevirapine Tablet; Oral SUPPL-3 Prinston Inc Labeling Approved
Nevirapine
ANDA #078644
Nevirapine Tablet; Oral SUPPL-5 Prinston Inc Labeling Approved
Nitrogen, Nf
NDA #214858
Nitrogen Gas; Inhalation ORIG-1 Air Liquide Canada Inc Approved
Phesgo
BLA #761170
Pertuzumab;Trastuzumab;Hyaluronidase-Zzxf Injectable; Intravenous, Subcutaneous ORIG-1 Genentech Inc Type 4 - New Combination Approved
Potassium Citrate
ANDA #212799
Potassium Citrate Tablet, Extended Release; Oral ORIG-1 Bionpharma Inc Approved
Yervoy
BLA #125377
Ipilimumab Injectable; Injection SUPPL-106 Bristol Myers Squibb Labeling Approved

June 26, 2020

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Cytarabine
ANDA #206189
Cytarabine Injectable; Injection ORIG-1 Hong Kong Approved
Doxorubicin Hydrochloride (Liposomal)
ANDA #203263
Doxorubicin Hydrochloride Injectable, Liposomal; Injection SUPPL-27 Sun Pharm Labeling Approved
Doxorubicin Hydrochloride (Liposomal)
ANDA #203263
Doxorubicin Hydrochloride Injectable, Liposomal; Injection SUPPL-27 Sun Pharm Labeling Approved
Doxorubicin Hydrochloride (Liposomal)
ANDA #208657
Doxorubicin Hydrochloride Injectable, Liposomal; Injection SUPPL-4 Dr Reddys Labs Ltd Labeling Approved
Fragmin
NDA #020287
Dalteparin Sodium Injectable; Injection SUPPL-74 Pfizer Inc Labeling Approved
Fragmin
NDA #020287
Dalteparin Sodium Injectable; Injection SUPPL-75 Pfizer Inc Labeling Approved
Fragmin
NDA #020287
Dalteparin Sodium Injectable; Subcutaneous SUPPL-74 Pfizer Inc Labeling Approved
Fragmin
NDA #020287
Dalteparin Sodium Injectable; Subcutaneous SUPPL-75 Pfizer Inc Labeling Approved
Lialda
NDA #022000
Mesalamine Tablet, Delayed Release; Oral SUPPL-19 Shire Efficacy Approved
Mycapssa
NDA #208232
Octreotide Capsule, Delayed Release; Oral ORIG-1 Chiasma Inc Type 5 - New Formulation or New Manufacturer Approved

June 25, 2020

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Amoxicillin
ANDA #205274
Amoxicillin Tablet, Chewable; Oral ORIG-1 Hikma Approved
Divalproex Sodium
ANDA #090407
Divalproex Sodium Capsule, Delayed Rel Pellets; Oral SUPPL-9 Mylan Labeling Approved
Divalproex Sodium
ANDA #090407
Divalproex Sodium Capsule, Delayed Rel Pellets; Oral SUPPL-13 Mylan Labeling Approved
Divalproex Sodium
ANDA #090407
Divalproex Sodium Capsule, Delayed Rel Pellets; Oral SUPPL-14 Mylan Labeling Approved
Divalproex Sodium
ANDA #090407
Divalproex Sodium Capsule, Delayed Rel Pellets; Oral SUPPL-8 Mylan Labeling Approved
Divalproex Sodium
ANDA #090407
Divalproex Sodium Capsule, Delayed Rel Pellets; Oral SUPPL-9 Mylan Labeling Approved
Divalproex Sodium
ANDA #090407
Divalproex Sodium Capsule, Delayed Rel Pellets; Oral SUPPL-10 Mylan Labeling Approved
Divalproex Sodium
ANDA #090407
Divalproex Sodium Capsule, Delayed Rel Pellets; Oral SUPPL-11 Mylan Labeling Approved
Divalproex Sodium
ANDA #090407
Divalproex Sodium Capsule, Delayed Rel Pellets; Oral SUPPL-12 Mylan Labeling Approved
Divalproex Sodium
ANDA #090407
Divalproex Sodium Capsule, Delayed Rel Pellets; Oral SUPPL-13 Mylan Labeling Approved
Divalproex Sodium
ANDA #090407
Divalproex Sodium Capsule, Delayed Rel Pellets; Oral SUPPL-14 Mylan Labeling Approved
Esomeprazole Magnesium
ANDA #212088
Esomeprazole Magnesium Tablet, Delayed Release; Oral ORIG-1 Mylan Approved
Fintepla
NDA #212102
Fenfluamine Solution; Oral ORIG-1 Zogenix Inc Type 3 - New Dosage Form Approved
Haloperidol Decanoate
ANDA #075393
Haloperidol Decanoate Injectable; Injection SUPPL-33 Teva Pharms Usa Labeling Approved
Haloperidol Decanoate
ANDA #075393
Haloperidol Decanoate Injectable; Injection SUPPL-33 Teva Pharms Usa Labeling Approved
Libtayo
BLA #761097
Cemiplimab-Rwlc Injectable; Intravenous SUPPL-5 Regeneron Pharmaceuticals Efficacy Approved
Nitroglycerin
ANDA #087355
Nitroglycerin Ointment; Transdermal SUPPL-33 Fougera Pharms Inc Labeling Approved
Prochlorperazine Edisylate
ANDA #204147
Prochlorperazine Edisylate Injectable; Injection SUPPL-25 Emcure Pharms Ltd Labeling Approved
Propafenone Hydrochloride
ANDA #212744
Propafenone Hydrochloride Capsule, Extended Release; Oral ORIG-1 Upsher Smith Labs Approved
Rocuronium Bromide
ANDA #091458
Rocuronium Bromide Injectable; Injection SUPPL-13 Sagent Pharms Inc Labeling Approved
Rocuronium Bromide
ANDA #091458
Rocuronium Bromide Injectable; Injection SUPPL-13 Sagent Pharms Inc Labeling Approved
Sumatriptan Succinate
ANDA #200263
Sumatriptan Succinate Tablet; Oral SUPPL-1 Corepharma Labeling Approved
Tranexamic Acid
ANDA #201580
Tranexamic Acid Injectable; Injection SUPPL-3 Xgen Pharms Labeling Approved

June 24, 2020

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Amiodarone Hydrochloride
ANDA #074739
Amiodarone Hydrochloride Tablet; Oral SUPPL-36 Teva Pharms Labeling Approved
Amiodarone Hydrochloride
ANDA #074739
Amiodarone Hydrochloride Tablet; Oral SUPPL-37 Teva Pharms Labeling Approved
Amiodarone Hydrochloride
ANDA #074739
Amiodarone Hydrochloride Tablet; Oral SUPPL-35 Teva Pharms Labeling Approved
Amiodarone Hydrochloride
ANDA #074739
Amiodarone Hydrochloride Tablet; Oral SUPPL-36 Teva Pharms Labeling Approved
Amiodarone Hydrochloride
ANDA #074739
Amiodarone Hydrochloride Tablet; Oral SUPPL-37 Teva Pharms Labeling Approved
Ammonia N 13
ANDA #203779
Ammonia N-13 Injectable; Intravenous SUPPL-1 3d Imaging Drug Manufacturing (CMC) Approved
Asparlas
BLA #761102
Calaspargase Pegol-Mknl Injectable; Intravenous SUPPL-3 Servier Pharma Llc Labeling Approved
Atacand
NDA #020838
Candesartan Cilexetil Tablet; Oral SUPPL-41 Ani Pharms Inc Labeling Approved
Atropine Sulfate Ansyr Plastic Syringe
NDA #021146
Atropine Sulfate Solution; Intravenous, Intramuscular, Subcutaneous, Endotracheal SUPPL-22 Hospira Labeling Approved
Atropine Sulfate Ansyr Plastic Syringe
NDA #021146
Atropine Sulfate Solution; Intravenous, Intramuscular, Subcutaneous, Endotracheal SUPPL-22 Hospira Labeling Approved
Atropine Sulfate Lifeshield Abboject Syringe
NDA #021146
Atropine Sulfate Solution; Intravenous SUPPL-22 Hospira Labeling Approved
Atropine Sulfate Lifeshield Abboject Syringe
NDA #021146
Atropine Sulfate Solution; Intravenous SUPPL-22 Hospira Labeling Approved
Benazepril Hydrochloride
ANDA #076344
Benazepril Hydrochloride Tablet; Oral SUPPL-18 Sun Pharm Inds Ltd Labeling Approved
Dexmedetomidine Hydrochloride
ANDA #205867
Dexmedetomidine Hydrochloride Injectable; Injection SUPPL-1 Aurobindo Pharma Ltd Labeling Approved
Dexmedetomidine Hydrochloride
ANDA #205867
Dexmedetomidine Hydrochloride Injectable; Injection SUPPL-2 Aurobindo Pharma Ltd Labeling Approved
Dexmedetomidine Hydrochloride
ANDA #205867
Dexmedetomidine Hydrochloride Injectable; Injection SUPPL-4 Aurobindo Pharma Ltd Labeling Approved
Dextroamp Saccharate, Amp Aspartate, Dextroamp Sulfate and Amp Sulfate
ANDA #211876
Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate Capsule, Extended Release; Oral ORIG-1 Mylan Approved
Drizalma Sprinkle
NDA #212516
Duloxetine Hydrochloride Capsule, Delayed Release; Oral SUPPL-1 Sun Pharma Global Labeling Approved
Fludeoxyglucose F18
ANDA #203778
Fludeoxyglucose F-18 Injectable; Intravenous SUPPL-2 3d Imaging Drug Manufacturing (CMC) Approved
Keytruda
BLA #125514
Pembrolizumab Powder, For Injection Solution, Lyophilized Powder SUPPL-92 Merck Sharp Dohme Efficacy Approved
Keytruda
BLA #125514
Pembrolizumab Powder, For Injection Solution, Lyophilized Powder SUPPL-68 Merck Sharp Dohme Efficacy Approved
Nevirapine
ANDA #078584
Nevirapine Tablet; Oral SUPPL-18 Hetero Labs Ltd Iii Labeling Approved
Nevirapine
ANDA #078584
Nevirapine Tablet; Oral SUPPL-19 Hetero Labs Ltd Iii Labeling Approved
Pitavastatin Calcium
ANDA #206015
Pitavastatin Calcium Tablet; Oral SUPPL-3 Aurobindo Pharma Ltd Labeling Approved
Pitavastatin Calcium
ANDA #206015
Pitavastatin Calcium Tablet; Oral SUPPL-4 Aurobindo Pharma Ltd Labeling Approved
Prasugrel
ANDA #205927
Prasugrel Hydrochloride Tablet; Oral SUPPL-3 Mylan Labeling Approved
Prasugrel
ANDA #205927
Prasugrel Hydrochloride Tablet; Oral SUPPL-3 Mylan Labeling Approved
Prednisone
ANDA #213386
Prednisone Tablet; Oral ORIG-1 Amneal Approved
Procysbi
NDA #203389
Cysteamine Bitartrate Capsule, Delayed Release; Oral SUPPL-23 Horizon Pharma Usa Labeling Approved
Procysbi
NDA #203389
Cysteamine Bitartrate Capsule, Delayed Release; Oral SUPPL-23 Horizon Pharma Usa Labeling Approved
Sodium Fluoride F-18
ANDA #203777
Sodium Fluoride F-18 Injectable; Intravenous SUPPL-1 3d Imaging Drug Manufacturing (CMC) Approved
Sumatriptan and Naproxen Sodium
ANDA #207457
Naproxen Sodium; Sumatriptan Succinate Tablet; Oral SUPPL-6 Aurobindo Pharma Ltd Labeling Approved
Sumatriptan and Naproxen Sodium
ANDA #207457
Naproxen Sodium; Sumatriptan Succinate Tablet; Oral SUPPL-6 Aurobindo Pharma Ltd Labeling Approved

June 23, 2020

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Amiodarone Hydrochloride
ANDA #075424
Amiodarone Hydrochloride Tablet; Oral SUPPL-31 Taro Labeling Approved
Amiodarone Hydrochloride
ANDA #075424
Amiodarone Hydrochloride Tablet; Oral SUPPL-31 Taro Labeling Approved
Amiodarone Hydrochloride
ANDA #076217
Amiodarone Hydrochloride Injectable; Injection SUPPL-33 Mylan Institutional Labeling Approved
Amiodarone Hydrochloride
ANDA #076362
Amiodarone Hydrochloride Tablet; Oral SUPPL-25 Taro Labeling Approved
Amiodarone Hydrochloride
ANDA #076362
Amiodarone Hydrochloride Tablet; Oral SUPPL-25 Taro Labeling Approved
Amiodarone Hydrochloride
ANDA #077161
Amiodarone Hydrochloride Injectable; Injection SUPPL-10 Gland Pharma Ltd Labeling Approved
Atorvastatin Calcium
ANDA #208478
Atorvastatin Calcium Tablet; Oral ORIG-1 Perrigo R and D Approved
Betamethasone Dipropionate
ANDA #206389
Betamethasone Dipropionate Lotion, Augmented; Topical SUPPL-1 Teligent Pharma Inc Labeling Approved
Betamethasone Dipropionate
ANDA #206389
Betamethasone Dipropionate Lotion, Augmented; Topical SUPPL-2 Teligent Pharma Inc Labeling Approved
Betamethasone Dipropionate
ANDA #206389
Betamethasone Dipropionate Lotion, Augmented; Topical SUPPL-2 Teligent Pharma Inc Labeling Approved
Buprenorphine Hydrochloride
ANDA #078331
Buprenorphine Hydrochloride Injectable; Injection SUPPL-7 Am Regent Labeling Approved
Buprenorphine Hydrochloride
ANDA #078331
Buprenorphine Hydrochloride Injectable; Injection SUPPL-9 Am Regent Labeling Approved
Buprenorphine Hydrochloride
ANDA #206586
Buprenorphine Hydrochloride Injectable; Injection SUPPL-1 Par Sterile Products Labeling Approved
Buprenorphine Hydrochloride
ANDA #206586
Buprenorphine Hydrochloride Injectable; Injection SUPPL-5 Par Sterile Products Labeling Approved
Gemcitabine Hydrochloride
ANDA #204549
Gemcitabine Hydrochloride Injectable; Injection SUPPL-3 Actavis Inc Labeling Approved
Meclizine Hydrochloride
ANDA #213957
Meclizine Hydrochloride Tablet; Oral ORIG-1 Zydus Approved
Mekinist
NDA #204114
Trametinib Dimethyl Sulfoxide Tablet; Oral SUPPL-16 Novartis Labeling Approved
Opdivo
BLA #125554
Nivolumab Injectable; Injection SUPPL-83 Bristol Myers Squibb Labeling Approved
Pantoprazole Sodium
NDA #209463
Pantoprazole Sodium Powder; Iv (Infusion) SUPPL-6 Hikma Labeling Approved
Simvastatin
ANDA #078155
Simvastatin Tablet; Oral SUPPL-35 Accord Hlthcare Labeling Approved
Teriflunomide
ANDA #209638
Teriflunomide Tablet; Oral SUPPL-3 Aurobindo Pharma Ltd Labeling Approved
Truvada
NDA #021752
Emtricitabine; Tenofovir Disoproxil Fumarate Tablet; Oral SUPPL-61 Gilead Labeling Approved
Tygacil
NDA #021821
Tigecycline Powder; Intravenous SUPPL-49 Pf Prism Cv Labeling Approved

June 22, 2020

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Amiodarone Hydrochloride
ANDA #076163
Amiodarone Hydrochloride Injectable; Injection SUPPL-17 Dr Reddys Labeling Approved
Amiodarone Hydrochloride
ANDA #076232
Amiodarone Hydrochloride Injectable; Injection SUPPL-1 Akorn Labeling Approved
Amiodarone Hydrochloride
ANDA #077834
Amiodarone Hydrochloride Injectable; Injection SUPPL-3 Wockhardt Labeling Approved
Clomipramine Hydrochloride
ANDA #213219
Clomipramine Hydrochloride Capsule; Oral ORIG-1 Micro Labs Approved
Clomipramine Hydrochloride
ANDA #213221
Clomipramine Hydrochloride Capsule; Oral ORIG-1 Vgyaan Approved
Dexmedetomidine Hydrochloride
ANDA #091465
Dexmedetomidine Hydrochloride Injectable; Injection SUPPL-2 Sandoz Inc Labeling Approved
Fluconazole
ANDA #076665
Fluconazole Tablet; Oral SUPPL-10 Chartwell Labeling Approved
Fluconazole
ANDA #076665
Fluconazole Tablet; Oral SUPPL-9 Chartwell Labeling Approved
Fluconazole
ANDA #076665
Fluconazole Tablet; Oral SUPPL-10 Chartwell Labeling Approved
Fluconazole
ANDA #076665
Fluconazole Tablet; Oral SUPPL-11 Chartwell Labeling Approved
Fluconazole
ANDA #076957
Fluconazole Tablet; Oral SUPPL-6 Unique Pharm Labs Labeling Approved
Fluconazole
ANDA #076957
Fluconazole Tablet; Oral SUPPL-8 Unique Pharm Labs Labeling Approved
Fluconazole
ANDA #076957
Fluconazole Tablet; Oral SUPPL-5 Unique Pharm Labs Labeling Approved
Fluconazole
ANDA #076957
Fluconazole Tablet; Oral SUPPL-6 Unique Pharm Labs Labeling Approved
Fluconazole
ANDA #076957
Fluconazole Tablet; Oral SUPPL-8 Unique Pharm Labs Labeling Approved
Gemfibrozil
ANDA #078599
Gemfibrozil Tablet; Oral SUPPL-3 Hikma Pharms Labeling Approved
Levaquin
NDA #020634
Levofloxacin Tablet; Oral SUPPL-73 Janssen Pharms Labeling Approved
Loperamide Hydrochloride
NDA #021855
Loperamide Hydrochloride Capsule; Oral SUPPL-14 Bionpharma Inc Labeling Approved
Lorazepam
ANDA #074793
Lorazepam Injectable; Injection SUPPL-2 Dava Pharms Inc Labeling Approved
Penicillin G Sodium
ANDA #065068
Penicillin G Sodium Injectable; Intramuscular, Intravenous SUPPL-22 Sandoz Labeling Approved
Teriflunomide
ANDA #209702
Teriflunomide Tablet; Oral SUPPL-1 Mylan Labeling Approved
Teriflunomide
ANDA #209702
Teriflunomide Tablet; Oral SUPPL-1 Mylan Labeling Approved
Xpovio
NDA #212306
Selinexor Tablet; Oral SUPPL-1 Karyopharm Theraps Efficacy Approved
Zolpidem Tartrate
ANDA #078184
Zolpidem Tartrate Tablet; Oral SUPPL-5 Invagen Pharms Labeling Approved
Zolpidem Tartrate
ANDA #078184
Zolpidem Tartrate Tablet; Oral SUPPL-5 Invagen Pharms Labeling Approved

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