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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