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.

June 21, 2021

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Methylphenidate Hydrochloride
ANDA #204772
Methylphenidate Hydrochloride Tablet, Extended Release; Oral SUPPL-3 Cnty Line Pharms Labeling Approved
Methylphenidate Hydrochloride
ANDA #207488
Methylphenidate Hydrochloride Tablet, Extended Release; Oral SUPPL-7 Abhai Llc Labeling Approved
Oxcarbazepine
ANDA #212428
Oxcarbazepine Suspension; Oral ORIG-1 Glasshouse Pharmaceuticals Ltd Canada Approved
Pradaxa
NDA #022512
Dabigatran Etexilate Mesylate Capsule; Oral SUPPL-41 Boehringer Ingelheim Efficacy Approved
Pradaxa
NDA #214358
Dabigatran Pellets; Oral ORIG-1 Boehringer Ingelheim Type 3 - New Dosage Form Approved

June 17, 2021

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Astepro Allergy
NDA #213872
Azelastine Hydrochloride Spray, Metered; Nasal ORIG-1 Bayer Healthcare Llc Type 8 - Partial Rx to OTC Switch Approved
Byetta
NDA #021773
Exenatide Synthetic Injectable; Subcutaneous SUPPL-44 Astrazeneca Ab Labeling Approved
Calcium Gluconate
NDA #208418
Calcium Gluconate Solution; Intravenous SUPPL-7 Fresenius Kabi Usa Labeling Approved
Children’S Astepro Allergy
NDA #213872
Azelastine Hydrochloride Spray, Metered; Nasal ORIG-1 Bayer Healthcare Llc Type 8 - Partial Rx to OTC Switch Approved
Dimethyl Fumarate
ANDA #210531
Dimethyl Fumarate Capsule, Delayed Release; Oral SUPPL-1 Mylan Manufacturing (CMC) Approved
Fentanyl Citrate
ANDA #212086
Fentanyl Citrate Injectable; Injection SUPPL-1 Fresenius Kabi Usa Manufacturing (CMC) Approved
Fentanyl Citrate
ANDA #212086
Fentanyl Citrate Injectable; Injection SUPPL-1 Fresenius Kabi Usa Manufacturing (CMC) Approved
Inflectra
BLA #125544
Infliximab-Dyyb Injectable; Injection SUPPL-18 Celltrion Inc Labeling Approved
Levorphanol Tartrate
ANDA #213906
Levorphanol Tartrate Tablet; Oral ORIG-1 Sun Pharm Inds Inc Approved
Loperamide Hydrochloride and Simethicone
ANDA #211438
Loperamide Hydrochloride; Simethicone Tablet; Oral ORIG-1 Hetero Labs Ltd V Approved
Noxafil
NDA #205053
Posaconazole Tablet, Delayed Release; Oral SUPPL-11 Merck Sharp Dohme Efficacy Approved
Noxafil
NDA #205596
Posaconazole Solution; Intravenous SUPPL-13 Merck Sharp Dohme Efficacy Approved
Olanzapine
ANDA #090881
Olanzapine Tablet, Orally Disintegrating; Oral SUPPL-8 Sun Pharm Inds Labeling Approved
Olanzapine
ANDA #090881
Olanzapine Tablet, Orally Disintegrating; Oral SUPPL-8 Sun Pharm Inds Labeling Approved
Perampanel
ANDA #209538
Perampanel Tablet; Oral ORIG-1 Taro Pharm Inds Ltd Tentative Approval
Qinlock
NDA #213973
Ripretinib Tablet; Oral SUPPL-1 Deciphera Pharms Labeling Approved
Rifadin
NDA #050420
Rifampin Capsule; Oral SUPPL-85 Sanofi Aventis Us Labeling Approved
Rifadin
NDA #050627
Rifampin Injectable; Injection SUPPL-28 Sanofi Aventis Us Labeling Approved
Rifater
NDA #050705
Isoniazid; Pyrazinamide; Rifampin Tablet; Oral SUPPL-19 Sanofi Aventis Us Labeling Approved
Sublocade
NDA #209819
Buprenorphine Solution, Extended Release; Subcutaneous SUPPL-18 Indivior Inc Labeling Approved
Toviaz
NDA #022030
Fesoterodine Fumarate Tablet, Extended Release; Oral SUPPL-19 Pfizer Efficacy Approved
Zoladex
NDA #019726
Goserelin Acetate Implant; Implantation SUPPL-66 Tersera Labeling Approved
Zoladex
NDA #019726
Goserelin Acetate Implant; Implantation SUPPL-66 Tersera Labeling Approved
Zoladex
NDA #020578
Goserelin Acetate Implant; Implantation SUPPL-44 Tersera Labeling Approved
Zoladex
NDA #020578
Goserelin Acetate Implant; Implantation SUPPL-44 Tersera Labeling Approved

June 16, 2021

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Alprazolam
ANDA #074312
Alprazolam Concentrate; Oral SUPPL-16 Hikma Manufacturing (CMC) Approved
Ayvakit
NDA #212608
Avapritinib Tablet; Oral SUPPL-6 Blueprint Medicines Efficacy Approved
Ayvakit
NDA #212608
Avapritinib Tablet; Oral SUPPL-7 Blueprint Medicines Efficacy Approved
Emtricitabine and Tenofovir Disoproxil Fumarate
ANDA #208740
Emtricitabine; Tenofovir Disoproxil Fumarate Tablet; Oral ORIG-1 Apotex Approved
Ibandronate Sodium
ANDA #204329
Ibandronate Sodium Injectable; Intravenous ORIG-1 Nang Kuang Pharm Co Approved
Ibuprofen
ANDA #209179
Ibuprofen Suspension; Oral SUPPL-1 Aurobindo Pharma Ltd Manufacturing (CMC) Approved
Micafungin
NDA #212156
Micafungin Sodium Injectable; Intravenous ORIG-1 Par Sterile Products Type 5 - New Formulation or New Manufacturer Approved
Sevelamer Hydrochloride
ANDA #213145
Sevelamer Hydrochloride Tablet; Oral ORIG-1 Lupin Ltd Approved
Talzenna
NDA #211651
Talazoparib Tosylate Capsule; Oral SUPPL-1 Pfizer Labeling Approved
Zelapar
NDA #021479
Selegiline Hydrochloride Tablet, Orally Disintegrating; Oral SUPPL-10 Bausch Labeling Approved

June 15, 2021

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Buprenorphine Hydrochloride and Naloxone Hydrochloride
ANDA #214930
Buprenorphine Hydrochloride; Naloxone Hydrochloride Tablet; Sublingual ORIG-1 Alkem Labs Ltd Approved
Cyramza
BLA #125477
Ramucirumab Injectable; Injection SUPPL-39 Eli Lilly and Co Labeling Approved
Lysodren
NDA #016885
Mitotane Tablet; Oral SUPPL-29 Hra Pharma Labeling Approved
Propecia
NDA #020788
Finasteride Tablet; Oral SUPPL-28 Merck Labeling Approved
Propecia
NDA #020788
Finasteride Tablet; Oral SUPPL-28 Merck Labeling Approved
Proscar
NDA #020180
Finasteride Tablet; Oral SUPPL-47 Merck Labeling Approved
Proscar
NDA #020180
Finasteride Tablet; Oral SUPPL-47 Merck Labeling Approved
Sapropterin Dihydrochloride
ANDA #207685
Sapropterin Dihydrochloride Tablet; Oral ORIG-1 Dr Reddys Approved
Sildenafil Citrate
ANDA #209302
Sildenafil Citrate Tablet; Oral SUPPL-3 Umedica Labs Pvt Ltd Manufacturing (CMC) Approved
Sodium Sulfate; Potassium Sulfate; Magnesium Sulfate
ANDA #212903
Sodium Sulfate;Potassium Sulfate;Magnesium Sulfate Unknown ORIG-1 Annora Pharma Tentative Approval

June 14, 2021

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Aminocaproic Acid
ANDA #212110
Aminocaproic Acid Tablet; Oral ORIG-1 Edenbridge Pharms Approved
Clobetasol Propionate
ANDA #214895
Clobetasol Propionate Shampoo; Topical ORIG-1 Amneal Approved
Diazepam
ANDA #070313
Diazepam Injectable; Injection SUPPL-24 West-Ward Pharms Int Labeling Approved
Dronabinol
ANDA #201463
Dronabinol Capsule; Oral SUPPL-6 Lannett Co Inc Manufacturing (CMC) Approved
Dupixent
BLA #761055
Dupilumab Injectable; Injection SUPPL-16 Regeneron Pharmaceuticals Efficacy Approved
Ephedrine Sulfate
ANDA #214579
Ephedrine Sulfate Solution; Intravenous ORIG-1 Aurobindo Pharma Ltd Approved
Etravirine
ANDA #214196
Etravirine Tablet; Oral ORIG-1 Amneal Approved
Lidocaine Hydrochloride
ANDA #083158
Lidocaine Hydrochloride Injectable; Injection SUPPL-122 Hospira Manufacturing (CMC) Approved
Lidocaine Hydrochloride 0.2% In Dextrose 5%
ANDA #083158
Lidocaine Hydrochloride Injectable; Injection SUPPL-122 Hospira Manufacturing (CMC) Approved
Lidocaine Hydrochloride 0.4% In Dextrose 5%
ANDA #083158
Lidocaine Hydrochloride Injectable; Injection SUPPL-122 Hospira Manufacturing (CMC) Approved
Methylin Er
ANDA #075629
Methylphenidate Hydrochloride Tablet, Extended Release; Oral SUPPL-18 Specgx Llc Labeling Approved
Methylin Er
ANDA #075629
Methylphenidate Hydrochloride Tablet, Extended Release; Oral SUPPL-20 Specgx Llc Labeling Approved
Rezipres
NDA #213536
Ephedrine Hydrochloride Injectable; Injection ORIG-1 Sintetica, Sa Type 5 - New Formulation or New Manufacturer Approved
Soaanz
NDA #213218
Torsemide Tablet; Oral ORIG-1 Sarfez Pharmaceuticals Inc Type 5 - New Formulation or New Manufacturer Approved
Sodium Bicarbonate
ANDA #202494
Sodium Bicarbonate Injectable; Injection SUPPL-9 Hospira Inc Manufacturing (CMC) Approved
Sodium Bicarbonate
ANDA #202495
Sodium Bicarbonate Injectable; Injection SUPPL-9 Hospira Inc Manufacturing (CMC) Approved
Sodium Bicarbonate
ANDA #202679
Sodium Bicarbonate Injectable; Injection SUPPL-10 Hospira Inc Manufacturing (CMC) Approved
Solosec
NDA #209363
Secnidazole Granule; Oral SUPPL-15 Lupin Labeling Approved
Solosec
NDA #209363
Secnidazole Granule; Oral SUPPL-15 Lupin Labeling Approved
Testosterone
ANDA #212882
Testosterone Solution, Metered; Transdermal ORIG-1 Aleor Dermaceuticals Approved
Trexall
ANDA #040385
Methotrexate Sodium Tablet; Oral SUPPL-21 Barr Labeling Approved
Trexall
ANDA #040385
Methotrexate Sodium Tablet; Oral SUPPL-21 Barr Labeling Approved
Trexall
ANDA #040385
Methotrexate Sodium Tablet; Oral SUPPL-21 Barr Labeling Approved
Valtrex
NDA #020487
Valacyclovir Hydrochloride Tablet; Oral SUPPL-22 Glaxosmithkline Labeling Approved
Valtrex
NDA #020487
Valacyclovir Hydrochloride Tablet; Oral SUPPL-22 Glaxosmithkline Labeling Approved

June 21, 2021

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Methylphenidate Hydrochloride
ANDA #204772
Methylphenidate Hydrochloride Tablet, Extended Release; Oral SUPPL-3 Cnty Line Pharms Labeling Approved
Methylphenidate Hydrochloride
ANDA #207488
Methylphenidate Hydrochloride Tablet, Extended Release; Oral SUPPL-7 Abhai Llc Labeling Approved
Oxcarbazepine
ANDA #212428
Oxcarbazepine Suspension; Oral ORIG-1 Glasshouse Pharmaceuticals Ltd Canada Approved
Pradaxa
NDA #022512
Dabigatran Etexilate Mesylate Capsule; Oral SUPPL-41 Boehringer Ingelheim Efficacy Approved
Pradaxa
NDA #214358
Dabigatran Pellets; Oral ORIG-1 Boehringer Ingelheim Type 3 - New Dosage Form Approved

June 17, 2021

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Astepro Allergy
NDA #213872
Azelastine Hydrochloride Spray, Metered; Nasal ORIG-1 Bayer Healthcare Llc Type 8 - Partial Rx to OTC Switch Approved
Byetta
NDA #021773
Exenatide Synthetic Injectable; Subcutaneous SUPPL-44 Astrazeneca Ab Labeling Approved
Calcium Gluconate
NDA #208418
Calcium Gluconate Solution; Intravenous SUPPL-7 Fresenius Kabi Usa Labeling Approved
Children’S Astepro Allergy
NDA #213872
Azelastine Hydrochloride Spray, Metered; Nasal ORIG-1 Bayer Healthcare Llc Type 8 - Partial Rx to OTC Switch Approved
Dimethyl Fumarate
ANDA #210531
Dimethyl Fumarate Capsule, Delayed Release; Oral SUPPL-1 Mylan Manufacturing (CMC) Approved
Fentanyl Citrate
ANDA #212086
Fentanyl Citrate Injectable; Injection SUPPL-1 Fresenius Kabi Usa Manufacturing (CMC) Approved
Fentanyl Citrate
ANDA #212086
Fentanyl Citrate Injectable; Injection SUPPL-1 Fresenius Kabi Usa Manufacturing (CMC) Approved
Inflectra
BLA #125544
Infliximab-Dyyb Injectable; Injection SUPPL-18 Celltrion Inc Labeling Approved
Levorphanol Tartrate
ANDA #213906
Levorphanol Tartrate Tablet; Oral ORIG-1 Sun Pharm Inds Inc Approved
Loperamide Hydrochloride and Simethicone
ANDA #211438
Loperamide Hydrochloride; Simethicone Tablet; Oral ORIG-1 Hetero Labs Ltd V Approved
Noxafil
NDA #205053
Posaconazole Tablet, Delayed Release; Oral SUPPL-11 Merck Sharp Dohme Efficacy Approved
Noxafil
NDA #205596
Posaconazole Solution; Intravenous SUPPL-13 Merck Sharp Dohme Efficacy Approved
Olanzapine
ANDA #090881
Olanzapine Tablet, Orally Disintegrating; Oral SUPPL-8 Sun Pharm Inds Labeling Approved
Olanzapine
ANDA #090881
Olanzapine Tablet, Orally Disintegrating; Oral SUPPL-8 Sun Pharm Inds Labeling Approved
Perampanel
ANDA #209538
Perampanel Tablet; Oral ORIG-1 Taro Pharm Inds Ltd Tentative Approval
Qinlock
NDA #213973
Ripretinib Tablet; Oral SUPPL-1 Deciphera Pharms Labeling Approved
Rifadin
NDA #050420
Rifampin Capsule; Oral SUPPL-85 Sanofi Aventis Us Labeling Approved
Rifadin
NDA #050627
Rifampin Injectable; Injection SUPPL-28 Sanofi Aventis Us Labeling Approved
Rifater
NDA #050705
Isoniazid; Pyrazinamide; Rifampin Tablet; Oral SUPPL-19 Sanofi Aventis Us Labeling Approved
Sublocade
NDA #209819
Buprenorphine Solution, Extended Release; Subcutaneous SUPPL-18 Indivior Inc Labeling Approved
Toviaz
NDA #022030
Fesoterodine Fumarate Tablet, Extended Release; Oral SUPPL-19 Pfizer Efficacy Approved
Zoladex
NDA #019726
Goserelin Acetate Implant; Implantation SUPPL-66 Tersera Labeling Approved
Zoladex
NDA #019726
Goserelin Acetate Implant; Implantation SUPPL-66 Tersera Labeling Approved
Zoladex
NDA #020578
Goserelin Acetate Implant; Implantation SUPPL-44 Tersera Labeling Approved
Zoladex
NDA #020578
Goserelin Acetate Implant; Implantation SUPPL-44 Tersera Labeling Approved

June 16, 2021

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Alprazolam
ANDA #074312
Alprazolam Concentrate; Oral SUPPL-16 Hikma Manufacturing (CMC) Approved
Ayvakit
NDA #212608
Avapritinib Tablet; Oral SUPPL-6 Blueprint Medicines Efficacy Approved
Ayvakit
NDA #212608
Avapritinib Tablet; Oral SUPPL-7 Blueprint Medicines Efficacy Approved
Emtricitabine and Tenofovir Disoproxil Fumarate
ANDA #208740
Emtricitabine; Tenofovir Disoproxil Fumarate Tablet; Oral ORIG-1 Apotex Approved
Ibandronate Sodium
ANDA #204329
Ibandronate Sodium Injectable; Intravenous ORIG-1 Nang Kuang Pharm Co Approved
Ibuprofen
ANDA #209179
Ibuprofen Suspension; Oral SUPPL-1 Aurobindo Pharma Ltd Manufacturing (CMC) Approved
Micafungin
NDA #212156
Micafungin Sodium Injectable; Intravenous ORIG-1 Par Sterile Products Type 5 - New Formulation or New Manufacturer Approved
Sevelamer Hydrochloride
ANDA #213145
Sevelamer Hydrochloride Tablet; Oral ORIG-1 Lupin Ltd Approved
Talzenna
NDA #211651
Talazoparib Tosylate Capsule; Oral SUPPL-1 Pfizer Labeling Approved
Zelapar
NDA #021479
Selegiline Hydrochloride Tablet, Orally Disintegrating; Oral SUPPL-10 Bausch Labeling Approved

June 15, 2021

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Buprenorphine Hydrochloride and Naloxone Hydrochloride
ANDA #214930
Buprenorphine Hydrochloride; Naloxone Hydrochloride Tablet; Sublingual ORIG-1 Alkem Labs Ltd Approved
Cyramza
BLA #125477
Ramucirumab Injectable; Injection SUPPL-39 Eli Lilly and Co Labeling Approved
Lysodren
NDA #016885
Mitotane Tablet; Oral SUPPL-29 Hra Pharma Labeling Approved
Propecia
NDA #020788
Finasteride Tablet; Oral SUPPL-28 Merck Labeling Approved
Propecia
NDA #020788
Finasteride Tablet; Oral SUPPL-28 Merck Labeling Approved
Proscar
NDA #020180
Finasteride Tablet; Oral SUPPL-47 Merck Labeling Approved
Proscar
NDA #020180
Finasteride Tablet; Oral SUPPL-47 Merck Labeling Approved
Sapropterin Dihydrochloride
ANDA #207685
Sapropterin Dihydrochloride Tablet; Oral ORIG-1 Dr Reddys Approved
Sildenafil Citrate
ANDA #209302
Sildenafil Citrate Tablet; Oral SUPPL-3 Umedica Labs Pvt Ltd Manufacturing (CMC) Approved
Sodium Sulfate; Potassium Sulfate; Magnesium Sulfate
ANDA #212903
Sodium Sulfate;Potassium Sulfate;Magnesium Sulfate Unknown ORIG-1 Annora Pharma Tentative Approval

June 14, 2021

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Aminocaproic Acid
ANDA #212110
Aminocaproic Acid Tablet; Oral ORIG-1 Edenbridge Pharms Approved
Clobetasol Propionate
ANDA #214895
Clobetasol Propionate Shampoo; Topical ORIG-1 Amneal Approved
Diazepam
ANDA #070313
Diazepam Injectable; Injection SUPPL-24 West-Ward Pharms Int Labeling Approved
Dronabinol
ANDA #201463
Dronabinol Capsule; Oral SUPPL-6 Lannett Co Inc Manufacturing (CMC) Approved
Dupixent
BLA #761055
Dupilumab Injectable; Injection SUPPL-16 Regeneron Pharmaceuticals Efficacy Approved
Ephedrine Sulfate
ANDA #214579
Ephedrine Sulfate Solution; Intravenous ORIG-1 Aurobindo Pharma Ltd Approved
Etravirine
ANDA #214196
Etravirine Tablet; Oral ORIG-1 Amneal Approved
Lidocaine Hydrochloride
ANDA #083158
Lidocaine Hydrochloride Injectable; Injection SUPPL-122 Hospira Manufacturing (CMC) Approved
Lidocaine Hydrochloride 0.2% In Dextrose 5%
ANDA #083158
Lidocaine Hydrochloride Injectable; Injection SUPPL-122 Hospira Manufacturing (CMC) Approved
Lidocaine Hydrochloride 0.4% In Dextrose 5%
ANDA #083158
Lidocaine Hydrochloride Injectable; Injection SUPPL-122 Hospira Manufacturing (CMC) Approved
Methylin Er
ANDA #075629
Methylphenidate Hydrochloride Tablet, Extended Release; Oral SUPPL-18 Specgx Llc Labeling Approved
Methylin Er
ANDA #075629
Methylphenidate Hydrochloride Tablet, Extended Release; Oral SUPPL-20 Specgx Llc Labeling Approved
Rezipres
NDA #213536
Ephedrine Hydrochloride Injectable; Injection ORIG-1 Sintetica, Sa Type 5 - New Formulation or New Manufacturer Approved
Soaanz
NDA #213218
Torsemide Tablet; Oral ORIG-1 Sarfez Pharmaceuticals Inc Type 5 - New Formulation or New Manufacturer Approved
Sodium Bicarbonate
ANDA #202494
Sodium Bicarbonate Injectable; Injection SUPPL-9 Hospira Inc Manufacturing (CMC) Approved
Sodium Bicarbonate
ANDA #202495
Sodium Bicarbonate Injectable; Injection SUPPL-9 Hospira Inc Manufacturing (CMC) Approved
Sodium Bicarbonate
ANDA #202679
Sodium Bicarbonate Injectable; Injection SUPPL-10 Hospira Inc Manufacturing (CMC) Approved
Solosec
NDA #209363
Secnidazole Granule; Oral SUPPL-15 Lupin Labeling Approved
Solosec
NDA #209363
Secnidazole Granule; Oral SUPPL-15 Lupin Labeling Approved
Testosterone
ANDA #212882
Testosterone Solution, Metered; Transdermal ORIG-1 Aleor Dermaceuticals Approved
Trexall
ANDA #040385
Methotrexate Sodium Tablet; Oral SUPPL-21 Barr Labeling Approved
Trexall
ANDA #040385
Methotrexate Sodium Tablet; Oral SUPPL-21 Barr Labeling Approved
Trexall
ANDA #040385
Methotrexate Sodium Tablet; Oral SUPPL-21 Barr Labeling Approved
Valtrex
NDA #020487
Valacyclovir Hydrochloride Tablet; Oral SUPPL-22 Glaxosmithkline Labeling Approved
Valtrex
NDA #020487
Valacyclovir Hydrochloride Tablet; Oral SUPPL-22 Glaxosmithkline Labeling Approved

June 11, 2021

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Bortezomib
ANDA #203654
Bortezomib Unknown ORIG-1 Sandoz Inc Tentative Approval
Brivaracetam
ANDA #214501
Brivaracetam Unknown ORIG-1 Zydus Pharms Usa Tentative Approval
Carfilzomib
ANDA #209330
Carfilzomib Powder; Intravenous ORIG-1 Breckenridge Approved
Carfilzomib
ANDA #209330
Carfilzomib Powder; Intravenous ORIG-2 Breckenridge Tentative Approval
Fulvestrant
ANDA #211730
Fulvestrant Injectable; Intramuscular ORIG-1 Apotex Approved
Glyxambi
NDA #206073
Empagliflozin; Linagliptin Tablet; Oral SUPPL-30 Boehringer Ingelheim Labeling Approved
Glyxambi
NDA #206073
Empagliflozin; Linagliptin Tablet; Oral SUPPL-27 Boehringer Ingelheim Labeling Approved
Hicon
NDA #021305
Sodium Iodide I-131 Solution; Oral SUPPL-47 Jubilant Labeling Approved
Jardiance
NDA #204629
Empagliflozin Tablet; Oral SUPPL-29 Boehringer Ingelheim Labeling Approved
Jardiance
NDA #204629
Empagliflozin Tablet; Oral SUPPL-28 Boehringer Ingelheim Labeling Approved
Levetiracetam
ANDA #091668
Levetiracetam Tablet, Extended Release; Oral SUPPL-1 Sandoz Labeling Approved
Levetiracetam
ANDA #215069
Levetiracetam Tablet; Oral ORIG-1 Sciegen Pharms Inc Approved
Levetiracetam
ANDA #215069
Levetiracetam Tablet; Oral ORIG-2 Sciegen Pharms Inc Tentative Approval
Pramipexole Dihydrochloride
ANDA #212797
Pramipexole Dihydrochloride Tablet, Extended Release; Oral ORIG-1 Xiamen Lp Pharm Co Approved
Sodium Iodide I 131
NDA #021305
Sodium Iodide I-131 Capsule; Oral SUPPL-47 Jubilant Labeling Approved
Synjardy
NDA #206111
Empagliflozin; Metformin Hydrochloride Tablet; Oral SUPPL-26 Boehringer Ingelheim Labeling Approved
Synjardy
NDA #206111
Empagliflozin; Metformin Hydrochloride Tablet; Oral SUPPL-25 Boehringer Ingelheim Labeling Approved
Synjardy Xr
NDA #208658
Empagliflozin; Metformin Hydrochloride Tablet, Extended Release; Oral SUPPL-15 Boehringer Ingelheim Labeling Approved
Synjardy Xr
NDA #208658
Empagliflozin; Metformin Hydrochloride Tablet, Extended Release; Oral SUPPL-13 Boehringer Ingelheim Labeling Approved
Temazepam
ANDA #211542
Temazepam Capsule; Oral SUPPL-1 Alembic Pharms Ltd Labeling Approved
Temazepam
ANDA #211542
Temazepam Capsule; Oral SUPPL-8 Alembic Pharms Ltd Labeling Approved
Temazepam
ANDA #211542
Temazepam Capsule; Oral SUPPL-1 Alembic Pharms Ltd Labeling Approved
Temazepam
ANDA #211542
Temazepam Capsule; Oral SUPPL-8 Alembic Pharms Ltd Labeling Approved
Trijardy Xr
NDA #212614
Empagliflozin; Linagliptin; Metformin Hydrochloride Tablet, Extended Release; Oral SUPPL-10 Boehringer Ingelheim Labeling Approved
Trijardy Xr
NDA #212614
Empagliflozin; Linagliptin; Metformin Hydrochloride Tablet, Extended Release; Oral SUPPL-8 Boehringer Ingelheim Labeling Approved
Vancoled
ANDA #062682
Vancomycin Hydrochloride Injectable; Injection SUPPL-18 West-Ward Pharms Int Labeling Approved
Vancoled
ANDA #062682
Vancomycin Hydrochloride Injectable; Injection SUPPL-19 West-Ward Pharms Int Labeling Approved
Vancomycin Hydrochloride
ANDA #062879
Vancomycin Hydrochloride Injectable; Injection SUPPL-17 West-Ward Pharms Int Labeling Approved
Vancomycin Hydrochloride
ANDA #062879
Vancomycin Hydrochloride Injectable; Injection SUPPL-18 West-Ward Pharms Int Labeling Approved

June 10, 2021

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Epclusa
NDA #208341
Sofosbuvir; Velpatasvir Tablet; Oral SUPPL-17 Gilead Sciences Inc Efficacy Approved
Epclusa
NDA #214187
Sofosbuvir;Velpatasvir Pellets; Oral ORIG-1 Gilead Sciences Inc Type 3 - New Dosage Form Approved
Levetiracetam
ANDA #091557
Levetiracetam Tablet, Extended Release; Oral SUPPL-9 Actavis Elizabeth Labeling Approved
Levetiracetam
ANDA #091557
Levetiracetam Tablet, Extended Release; Oral SUPPL-9 Actavis Elizabeth Labeling Approved
Levetiracetam
ANDA #091557
Levetiracetam Tablet, Extended Release; Oral SUPPL-10 Actavis Elizabeth Labeling Approved
Levetiracetam
ANDA #091557
Levetiracetam Tablet, Extended Release; Oral SUPPL-11 Actavis Elizabeth Labeling Approved
Levetiracetam
ANDA #091557
Levetiracetam Tablet, Extended Release; Oral SUPPL-9 Actavis Elizabeth Labeling Approved
Levetiracetam
ANDA #091557
Levetiracetam Tablet, Extended Release; Oral SUPPL-10 Actavis Elizabeth Labeling Approved
Levetiracetam
ANDA #091557
Levetiracetam Tablet, Extended Release; Oral SUPPL-11 Actavis Elizabeth Labeling Approved
Mavyret
NDA #209394
Glecaprevir; Pibrentasvir Tablet; Oral SUPPL-13 Abbvie Inc Efficacy Approved
Mavyret
NDA #215110
Glecaprevir; Pibrentasvir Tablet; Oral ORIG-1 Abbvie Inc Type 3 - New Dosage Form Approved
Rituxan Hycela
BLA #761064
Rituximab; Hyaluronidase (Human Recombinant) Solution; Subcutaneous SUPPL-13 Genentech Inc Labeling Approved
Sodium Phenylacetate; Sodium Benzoate
NDA #215025
Sodium Phenylacetate;Sodium Benzoate Injectable; Injection ORIG-1 Maia Pharms Inc Type 5 - New Formulation or New Manufacturer Approved
Tofacitinib
ANDA #209633
Tofacitinib Unknown ORIG-1 Breckenridge Pharms Tentative Approval
Treanda
NDA #022249
Bendamustine Hydrochloride Powder; Iv (Infusion) SUPPL-25 Cephalon Labeling Approved
Treanda
NDA #022249
Bendamustine Hydrochloride Solution; Iv (Infusion) SUPPL-25 Cephalon Labeling Approved
Venlafaxine Hydrochloride
ANDA #214127
Venlafaxine Hydrochloride Tablet, Extended Release; Oral ORIG-1 Alkem Labs Ltd Approved

June 9, 2021

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Betoptic S
NDA #019845
Betaxolol Hydrochloride Suspension/Drops; Ophthalmic SUPPL-30 Novartis Labeling Approved
Fludeoxyglucose F18
ANDA #203246
Fludeoxyglucose F-18 Injectable; Intravenous SUPPL-4 Univ Tx Md Anderson Labeling Approved
Izba
NDA #204822
Travoprost Solution/Drops; Ophthalmic SUPPL-2 Novartis Labeling Approved
Metadate Er
ANDA #040306
Methylphenidate Hydrochloride Tablet, Extended Release; Oral SUPPL-19 Lannett Co Inc Labeling Approved
Metadate Er
ANDA #040306
Methylphenidate Hydrochloride Tablet, Extended Release; Oral SUPPL-18 Lannett Co Inc Labeling Approved
Metadate Er
ANDA #040306
Methylphenidate Hydrochloride Tablet, Extended Release; Oral SUPPL-19 Lannett Co Inc Labeling Approved
Metoprolol Tartrate
ANDA #074133
Metoprolol Tartrate Injectable; Injection SUPPL-36 Hospira Labeling Approved
Metoprolol Tartrate
ANDA #075160
Metoprolol Tartrate Injectable; Injection SUPPL-21 Hospira Labeling Approved
Myalept
BLA #125390
Metreleptin Injectable; Injection SUPPL-23 Aegerion REMS Approved

June 8, 2021

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Ambrisentan
ANDA #208252
Ambrisentan Tablet; Oral SUPPL-4 Watson Labs Inc REMS Approved
Ambrisentan
ANDA #208354
Ambrisentan Tablet; Oral SUPPL-4 Sigmapharm Labs Llc REMS Approved
Ambrisentan
ANDA #208441
Ambrisentan Tablet; Oral SUPPL-3 Mylan REMS Approved
Ambrisentan
ANDA #209509
Ambrisentan Tablet; Oral SUPPL-4 Par Pharm Inc REMS Approved
Ambrisentan
ANDA #210058
Ambrisentan Tablet; Oral SUPPL-6 Zydus Pharms REMS Approved
Ambrisentan
ANDA #210715
Ambrisentan Tablet; Oral SUPPL-6 Cipla REMS Approved
Ambrisentan
ANDA #210784
Ambrisentan Tablet; Oral SUPPL-6 Sun Pharm REMS Approved
Atorvastatin Calcium
ANDA #076477
Atorvastatin Calcium Tablet; Oral SUPPL-10 Sun Pharm Inds Ltd Labeling Approved
Atorvastatin Calcium
ANDA #076477
Atorvastatin Calcium Tablet; Oral SUPPL-12 Sun Pharm Inds Ltd Labeling Approved
Atorvastatin Calcium
ANDA #076477
Atorvastatin Calcium Tablet; Oral SUPPL-17 Sun Pharm Inds Ltd Labeling Approved
Atorvastatin Calcium
ANDA #076477
Atorvastatin Calcium Tablet; Oral SUPPL-10 Sun Pharm Inds Ltd Labeling Approved
Atorvastatin Calcium
ANDA #076477
Atorvastatin Calcium Tablet; Oral SUPPL-12 Sun Pharm Inds Ltd Labeling Approved
Atorvastatin Calcium
ANDA #076477
Atorvastatin Calcium Tablet; Oral SUPPL-15 Sun Pharm Inds Ltd Labeling Approved
Atorvastatin Calcium
ANDA #076477
Atorvastatin Calcium Tablet; Oral SUPPL-17 Sun Pharm Inds Ltd Labeling Approved
Atorvastatin Calcium
ANDA #076477
Atorvastatin Calcium Tablet; Oral SUPPL-23 Sun Pharm Inds Ltd Labeling Approved
Atorvastatin Calcium
ANDA #076477
Atorvastatin Calcium Tablet; Oral SUPPL-26 Sun Pharm Inds Ltd Labeling Approved
Atorvastatin Calcium
ANDA #076477
Atorvastatin Calcium Tablet; Oral SUPPL-27 Sun Pharm Inds Ltd Labeling Approved
Atorvastatin Calcium
ANDA #076477
Atorvastatin Calcium Tablet; Oral SUPPL-12 Sun Pharm Inds Ltd Labeling Approved
Atorvastatin Calcium
ANDA #076477
Atorvastatin Calcium Tablet; Oral SUPPL-17 Sun Pharm Inds Ltd Labeling Approved
Atorvastatin Calcium
ANDA #076477
Atorvastatin Calcium Tablet; Oral SUPPL-23 Sun Pharm Inds Ltd Labeling Approved
Letairis
NDA #022081
Ambrisentan Tablet; Oral SUPPL-43 Gilead REMS Approved
Lignospan Forte
ANDA #088389
Epinephrine Bitartrate; Lidocaine Hydrochloride Injectable; Injection SUPPL-47 Deproco Labeling Approved
Lignospan Forte
ANDA #088389
Epinephrine Bitartrate; Lidocaine Hydrochloride Injectable; Injection SUPPL-47 Deproco Labeling Approved
Lignospan Standard
ANDA #088390
Epinephrine Bitartrate; Lidocaine Hydrochloride Injectable; Injection SUPPL-55 Deproco Labeling Approved
Mirena
NDA #021225
Levonorgestrel Intrauterine Device; Intrauterine SUPPL-36 Bayer Hlthcare Labeling Approved
Perampanel
ANDA #209801
Perampanel Tablet; Oral ORIG-1 Teva Pharms Usa Inc Approved
Perampanel
ANDA #209877
Perampanel Tablet; Oral ORIG-1 Accord Hlthcare Approved
Trikafta (Copackaged)
NDA #212273
Elexacaftor, Ivacaftor, Tezacaftor; Ivacaftor Tablet, Tablet; Oral SUPPL-4 Vertex Pharms Inc Efficacy Approved

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