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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