Drugs@FDA: FDA Approved Drug Products
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.
March 15, 2019
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Albuterol Sulfate
ANDA #210948 |
Albuterol Sulfate | Tablet; Oral | ORIG-1 | Aizant | Approved | |
| Aptiom
NDA #022416 |
Eslicarbazepine Acetate | Tablet; Oral | SUPPL-11 | Sunovion Pharms Inc | Efficacy | Approved |
| Clarinex
NDA #021165 |
Desloratadine | Tablet; Oral | SUPPL-22 | Merck Sharp Dohme | Labeling | Approved |
| Clarinex
NDA #021300 |
Desloratadine | Solution; Oral | SUPPL-19 | Merck Sharp Dohme | Labeling | Approved |
| Clarinex
NDA #021312 |
Desloratadine | Tablet, Orally Disintegrating; Oral | SUPPL-20 | Merck Sharp Dohme | Labeling | Approved |
| Clarinex
NDA #021563 |
Desloratadine | Syrup; Oral | SUPPL-8 | Schering | Labeling | Approved |
| Clarinex D 24 Hour
NDA #021605 |
Desloratadine; Pseudoephedrine Sulfate | Tablet, Extended Release; Oral | SUPPL-17 | Merck Sharp Dohme | Labeling | Approved |
| Clarinex-D 12 Hour
NDA #021313 |
Desloratadine; Pseudoephedrine Sulfate | Tablet, Extended Release; Oral | SUPPL-12 | Merck Sharp Dohme | Labeling | Approved |
| Dificid
NDA #201699 |
Fidaxomicin | Tablet; Oral | SUPPL-10 | Cubist Pharms Llc | Labeling | Approved |
| Efavirenz; Lamivudine; Tenofovir Disoproxil Fumarate
NDA #210649 |
Efavirenz;Lamivudine;Tenofovir Disoproxil Fumarate | Tablet; Oral | ORIG-1 | Macleods Pharms Ltd | Type 5 - New Formulation or New Manufacturer | Approved |
| Valsartan and Hydrochlorothiazide
ANDA #203000 |
Hydrochlorothiazide; Valsartan | Tablet; Oral | ORIG-1 | Zydus Pharms Usa Inc | Approved |
March 14, 2019
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Avycaz
NDA #206494 |
Avibactam Sodium; Ceftazidime | Powder; Iv (Infusion) | SUPPL-5 | Allergan Sales Llc | Efficacy | Approved |
| Avycaz
NDA #206494 |
Avibactam Sodium; Ceftazidime | Powder; Iv (Infusion) | SUPPL-6 | Allergan Sales Llc | Efficacy | Approved |
| Clindamycin Phosphate and Benzoyl Peroxide
ANDA #209252 |
Benzoyl Peroxide; Clindamycin Phosphate | Gel; Topical | ORIG-1 | Glenmark Pharms | Approved | |
| Enoxaparin Sodium
ANDA #208600 |
Enoxaparin Sodium | Injectable; Intravenous, Subcutaneous | ORIG-1 | Amphastar Pharms Inc | Approved | |
| Eptifibatide
ANDA #204361 |
Eptifibatide | Injectable; Injection | ORIG-1 | Usv | Approved | |
| Helidac
NDA #050719 |
Bismuth Subsalicylate; Metronidazole; Tetracycline Hydrochloride | Tablet, Chewable, Tablet, Capsule; Oral | SUPPL-22 | Casper Pharma Llc | Labeling | Approved |
March 13, 2019
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Children's Cetirizine Hydrochloride Allergy
ANDA #210622 |
Cetirizine Hydrochloride | Syrup; Oral | ORIG-1 | Hetero Labs Ltd Iii | Approved | |
| Docetaxel
ANDA #209634 |
Docetaxel | Injectable; Injection | SUPPL-2 | Cipla | Labeling | Approved |
| Fenoglide
NDA #022118 |
Fenofibrate | Tablet; Oral | SUPPL-9 | Santarus Inc | Labeling | Approved |
| Metformin Hydrochloride;Sitagliptin Phosphate
ANDA #209573 |
Metformin Hydrochloride;Sitagliptin Phosphate | Unknown | ORIG-1 | Zydus Pharms Usa Inc | Tentative Approval | |
| Nordette-28
NDA #018782 |
Ethinyl Estradiol; Levonorgestrel | Tablet; Oral-28 | SUPPL-39 | Teva Branded Pharm | Labeling | Approved |
| Sodium Chloride 3% In Plastic Container
ANDA #209476 |
Sodium Chloride | Injectable; Injection | ORIG-1 | Fresenius Kabi Usa | Approved | |
| Solifenacin Succinate
ANDA #211423 |
Solifenacin Succinate | Unknown | ORIG-1 | Cspc Ouyi Pharm Co | Tentative Approval |
March 12, 2019
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Allopurinol
ANDA #211820 |
Allopurinol | Tablet; Oral | ORIG-1 | Unichem Labs Ltd | Approved | |
| Apriso
NDA #022301 |
Mesalamine | Capsule, Extended Release; Oral | SUPPL-14 | Valeant Pharms Intl | Labeling | Approved |
| Bidil
NDA #020727 |
Hydralazine Hydrochloride; Isosorbide Dinitrate | Tablet; Oral | SUPPL-10 | Arbor Pharms Llc | Labeling | Approved |
| Desonide
ANDA #212002 |
Desonide | Ointment; Topical | ORIG-1 | Teligent Pharma Inc | Approved | |
| Loratadine
ANDA #207569 |
Loratadine | Tablet; Oral | ORIG-1 | Newgen Pharms Llc | Approved | |
| Nifedipine
ANDA #210614 |
Nifedipine | Tablet, Extended Release; Oral | ORIG-1 | Novast Labs | Approved | |
| Rocklatan
NDA #208259 |
Netarsudil;Latanoprost | Solution; Ophthalmic | ORIG-1 | Aerie Pharms Inc | Approved | |
| Tetracaine Hydrochloride
NDA #210821 |
Tetracaine Hydrochloride | Solution; Ophthalmic | ORIG-1 | Bausch Health Ireland Limited | Type 5 - New Formulation or New Manufacturer | Approved |
| Tizanidine Hydrochloride
ANDA #210267 |
Tizanidine Hydrochloride | Capsule; Oral | ORIG-1 | Riconpharma Llc | Approved | |
| Valsartan
ANDA #205536 |
Valsartan | Tablet; Oral | ORIG-1 | Alkem Labs Ltd | Approved | |
| Visipaque 270
NDA #020351 |
Iodixanol | Injectable; Injection | SUPPL-48 | Ge Healthcare | Labeling | Approved |
| Visipaque 270
NDA #020808 |
Iodixanol | Injectable; Injection | SUPPL-28 | Ge Healthcare | Labeling | Approved |
| Visipaque 320
NDA #020351 |
Iodixanol | Injectable; Injection | SUPPL-48 | Ge Healthcare | Labeling | Approved |
| Visipaque 320
NDA #020808 |
Iodixanol | Injectable; Injection | SUPPL-28 | Ge Healthcare | Labeling | Approved |
March 11, 2019
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Aimovig
BLA #761077 |
Erenumab-Aooe | Injectable; Injection | SUPPL-1 | Amgen Inc | Efficacy | Approved |
| Bleomycin Sulfate
ANDA #209439 |
Bleomycin Sulfate | Injectable; Injection | ORIG-1 | Cipla | Approved | |
| Brimonidine Tartrate
ANDA #208992 |
Brimonidine Tartrate | Solution/Drops; Ophthalmic | ORIG-1 | Somerset Theraps Llc | Approved | |
| Dalfampridine
ANDA #210158 |
Dalfampridine | Tablet, Extended Release; Oral | ORIG-1 | Micro Labs | Approved | |
| Dupixent
BLA #761055 |
Dupilumab | Injectable; Injection | SUPPL-12 | Regeneron Pharmaceuticals | Efficacy | Approved |
| Enzalutamide
ANDA #209614 |
Enzalutamide | Unknown | ORIG-1 | Actavis Labs Fl Inc | Tentative Approval | |
| Eptifibatide
ANDA #204362 |
Eptifibatide | Injectable; Injection | ORIG-1 | Usv | Approved | |
| Faslodex
NDA #021344 |
Fulvestrant | Injectable; Intramuscular | SUPPL-37 | Astrazeneca | Efficacy | Approved |
| Nikki
ANDA #201661 |
Drospirenone; Ethinyl Estradiol | Tablet; Oral | SUPPL-1 | Lupin Ltd | Labeling | Approved |
| Nikki
ANDA #201661 |
Drospirenone; Ethinyl Estradiol | Tablet; Oral | SUPPL-4 | Lupin Ltd | Labeling | Approved |
| Nikki
ANDA #201661 |
Drospirenone; Ethinyl Estradiol | Tablet; Oral | SUPPL-6 | Lupin Ltd | Manufacturing (CMC) | Approved |
| Nikki
ANDA #201661 |
Drospirenone; Ethinyl Estradiol | Tablet; Oral | SUPPL-4 | Lupin Ltd | Labeling | Approved |
| Noxafil
NDA #022003 |
Posaconazole | Suspension; Oral | SUPPL-24 | Schering | Labeling | Approved |
| Noxafil
NDA #205053 |
Posaconazole | Tablet, Delayed Release; Oral | SUPPL-8 | Merck Sharp Dohme | Labeling | Approved |
| Noxafil
NDA #205596 |
Posaconazole | Solution; Intravenous | SUPPL-7 | Merck Sharp Dohme | Labeling | Approved |
| Potassium Chloride
ANDA #208445 |
Potassium Chloride | Capsule, Extended Release; Oral | ORIG-1 | Zydus Pharms Usa Inc | Approved | |
| Prochlorperazine Edisylate
ANDA #040540 |
Prochlorperazine Edisylate | Injectable; Injection | SUPPL-16 | Athenex Inc | Manufacturing (CMC) | Approved |
| Trazimera
BLA #761081 |
Trastuzumab-Qyyp | Injectable; Injection | ORIG-1 | Pfizer Inc | Approved |
March 10, 2019
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Aspirin and Dipyridamole
ANDA #206753 |
Aspirin; Dipyridamole | Capsule, Extended Release; Oral | SUPPL-2 | Zydus Pharms Usa Inc | Labeling | Approved |
| Aspirin and Dipyridamole
ANDA #206753 |
Aspirin; Dipyridamole | Capsule, Extended Release; Oral | SUPPL-2 | Zydus Pharms Usa Inc | Labeling | Approved |
| Aspirin and Dipyridamole
ANDA #209048 |
Aspirin; Dipyridamole | Capsule, Extended Release; Oral | SUPPL-1 | Dr Reddys Labs Ltd | Labeling | Approved |
| Aspirin and Dipyridamole
ANDA #209048 |
Aspirin; Dipyridamole | Capsule, Extended Release; Oral | SUPPL-1 | Dr Reddys Labs Ltd | Labeling | Approved |
| Entecavir
ANDA #206217 |
Entecavir | Tablet; Oral | SUPPL-5 | Aurobindo Pharma Ltd | Labeling | Approved |
| Entecavir
ANDA #206217 |
Entecavir | Tablet; Oral | SUPPL-2 | Aurobindo Pharma Ltd | Labeling | Approved |
| Entecavir
ANDA #206217 |
Entecavir | Tablet; Oral | SUPPL-5 | Aurobindo Pharma Ltd | Labeling | Approved |
| Entecavir
ANDA #206217 |
Entecavir | Tablet; Oral | SUPPL-6 | Aurobindo Pharma Ltd | Labeling | Approved |
| Entecavir
ANDA #206217 |
Entecavir | Tablet; Oral | SUPPL-7 | Aurobindo Pharma Ltd | Labeling | Approved |
| Torsemide
ANDA #076110 |
Torsemide | Tablet; Oral | SUPPL-6 | Teva | Labeling | Approved |
March 15, 2019
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Albuterol Sulfate
ANDA #210948 |
Albuterol Sulfate | Tablet; Oral | ORIG-1 | Aizant | Approved | |
| Aptiom
NDA #022416 |
Eslicarbazepine Acetate | Tablet; Oral | SUPPL-11 | Sunovion Pharms Inc | Efficacy | Approved |
| Clarinex
NDA #021165 |
Desloratadine | Tablet; Oral | SUPPL-22 | Merck Sharp Dohme | Labeling | Approved |
| Clarinex
NDA #021300 |
Desloratadine | Solution; Oral | SUPPL-19 | Merck Sharp Dohme | Labeling | Approved |
| Clarinex
NDA #021312 |
Desloratadine | Tablet, Orally Disintegrating; Oral | SUPPL-20 | Merck Sharp Dohme | Labeling | Approved |
| Clarinex
NDA #021563 |
Desloratadine | Syrup; Oral | SUPPL-8 | Schering | Labeling | Approved |
| Clarinex D 24 Hour
NDA #021605 |
Desloratadine; Pseudoephedrine Sulfate | Tablet, Extended Release; Oral | SUPPL-17 | Merck Sharp Dohme | Labeling | Approved |
| Clarinex-D 12 Hour
NDA #021313 |
Desloratadine; Pseudoephedrine Sulfate | Tablet, Extended Release; Oral | SUPPL-12 | Merck Sharp Dohme | Labeling | Approved |
| Dificid
NDA #201699 |
Fidaxomicin | Tablet; Oral | SUPPL-10 | Cubist Pharms Llc | Labeling | Approved |
| Efavirenz; Lamivudine; Tenofovir Disoproxil Fumarate
NDA #210649 |
Efavirenz;Lamivudine;Tenofovir Disoproxil Fumarate | Tablet; Oral | ORIG-1 | Macleods Pharms Ltd | Type 5 - New Formulation or New Manufacturer | Approved |
| Valsartan and Hydrochlorothiazide
ANDA #203000 |
Hydrochlorothiazide; Valsartan | Tablet; Oral | ORIG-1 | Zydus Pharms Usa Inc | Approved |
March 14, 2019
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Avycaz
NDA #206494 |
Avibactam Sodium; Ceftazidime | Powder; Iv (Infusion) | SUPPL-5 | Allergan Sales Llc | Efficacy | Approved |
| Avycaz
NDA #206494 |
Avibactam Sodium; Ceftazidime | Powder; Iv (Infusion) | SUPPL-6 | Allergan Sales Llc | Efficacy | Approved |
| Clindamycin Phosphate and Benzoyl Peroxide
ANDA #209252 |
Benzoyl Peroxide; Clindamycin Phosphate | Gel; Topical | ORIG-1 | Glenmark Pharms | Approved | |
| Enoxaparin Sodium
ANDA #208600 |
Enoxaparin Sodium | Injectable; Intravenous, Subcutaneous | ORIG-1 | Amphastar Pharms Inc | Approved | |
| Eptifibatide
ANDA #204361 |
Eptifibatide | Injectable; Injection | ORIG-1 | Usv | Approved | |
| Helidac
NDA #050719 |
Bismuth Subsalicylate; Metronidazole; Tetracycline Hydrochloride | Tablet, Chewable, Tablet, Capsule; Oral | SUPPL-22 | Casper Pharma Llc | Labeling | Approved |
March 13, 2019
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Children's Cetirizine Hydrochloride Allergy
ANDA #210622 |
Cetirizine Hydrochloride | Syrup; Oral | ORIG-1 | Hetero Labs Ltd Iii | Approved | |
| Docetaxel
ANDA #209634 |
Docetaxel | Injectable; Injection | SUPPL-2 | Cipla | Labeling | Approved |
| Fenoglide
NDA #022118 |
Fenofibrate | Tablet; Oral | SUPPL-9 | Santarus Inc | Labeling | Approved |
| Metformin Hydrochloride;Sitagliptin Phosphate
ANDA #209573 |
Metformin Hydrochloride;Sitagliptin Phosphate | Unknown | ORIG-1 | Zydus Pharms Usa Inc | Tentative Approval | |
| Nordette-28
NDA #018782 |
Ethinyl Estradiol; Levonorgestrel | Tablet; Oral-28 | SUPPL-39 | Teva Branded Pharm | Labeling | Approved |
| Sodium Chloride 3% In Plastic Container
ANDA #209476 |
Sodium Chloride | Injectable; Injection | ORIG-1 | Fresenius Kabi Usa | Approved | |
| Solifenacin Succinate
ANDA #211423 |
Solifenacin Succinate | Unknown | ORIG-1 | Cspc Ouyi Pharm Co | Tentative Approval |
March 12, 2019
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Allopurinol
ANDA #211820 |
Allopurinol | Tablet; Oral | ORIG-1 | Unichem Labs Ltd | Approved | |
| Apriso
NDA #022301 |
Mesalamine | Capsule, Extended Release; Oral | SUPPL-14 | Valeant Pharms Intl | Labeling | Approved |
| Bidil
NDA #020727 |
Hydralazine Hydrochloride; Isosorbide Dinitrate | Tablet; Oral | SUPPL-10 | Arbor Pharms Llc | Labeling | Approved |
| Desonide
ANDA #212002 |
Desonide | Ointment; Topical | ORIG-1 | Teligent Pharma Inc | Approved | |
| Loratadine
ANDA #207569 |
Loratadine | Tablet; Oral | ORIG-1 | Newgen Pharms Llc | Approved | |
| Nifedipine
ANDA #210614 |
Nifedipine | Tablet, Extended Release; Oral | ORIG-1 | Novast Labs | Approved | |
| Rocklatan
NDA #208259 |
Netarsudil;Latanoprost | Solution; Ophthalmic | ORIG-1 | Aerie Pharms Inc | Approved | |
| Tetracaine Hydrochloride
NDA #210821 |
Tetracaine Hydrochloride | Solution; Ophthalmic | ORIG-1 | Bausch Health Ireland Limited | Type 5 - New Formulation or New Manufacturer | Approved |
| Tizanidine Hydrochloride
ANDA #210267 |
Tizanidine Hydrochloride | Capsule; Oral | ORIG-1 | Riconpharma Llc | Approved | |
| Valsartan
ANDA #205536 |
Valsartan | Tablet; Oral | ORIG-1 | Alkem Labs Ltd | Approved | |
| Visipaque 270
NDA #020351 |
Iodixanol | Injectable; Injection | SUPPL-48 | Ge Healthcare | Labeling | Approved |
| Visipaque 270
NDA #020808 |
Iodixanol | Injectable; Injection | SUPPL-28 | Ge Healthcare | Labeling | Approved |
| Visipaque 320
NDA #020351 |
Iodixanol | Injectable; Injection | SUPPL-48 | Ge Healthcare | Labeling | Approved |
| Visipaque 320
NDA #020808 |
Iodixanol | Injectable; Injection | SUPPL-28 | Ge Healthcare | Labeling | Approved |
March 11, 2019
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Aimovig
BLA #761077 |
Erenumab-Aooe | Injectable; Injection | SUPPL-1 | Amgen Inc | Efficacy | Approved |
| Bleomycin Sulfate
ANDA #209439 |
Bleomycin Sulfate | Injectable; Injection | ORIG-1 | Cipla | Approved | |
| Brimonidine Tartrate
ANDA #208992 |
Brimonidine Tartrate | Solution/Drops; Ophthalmic | ORIG-1 | Somerset Theraps Llc | Approved | |
| Dalfampridine
ANDA #210158 |
Dalfampridine | Tablet, Extended Release; Oral | ORIG-1 | Micro Labs | Approved | |
| Dupixent
BLA #761055 |
Dupilumab | Injectable; Injection | SUPPL-12 | Regeneron Pharmaceuticals | Efficacy | Approved |
| Enzalutamide
ANDA #209614 |
Enzalutamide | Unknown | ORIG-1 | Actavis Labs Fl Inc | Tentative Approval | |
| Eptifibatide
ANDA #204362 |
Eptifibatide | Injectable; Injection | ORIG-1 | Usv | Approved | |
| Faslodex
NDA #021344 |
Fulvestrant | Injectable; Intramuscular | SUPPL-37 | Astrazeneca | Efficacy | Approved |
| Nikki
ANDA #201661 |
Drospirenone; Ethinyl Estradiol | Tablet; Oral | SUPPL-1 | Lupin Ltd | Labeling | Approved |
| Nikki
ANDA #201661 |
Drospirenone; Ethinyl Estradiol | Tablet; Oral | SUPPL-4 | Lupin Ltd | Labeling | Approved |
| Nikki
ANDA #201661 |
Drospirenone; Ethinyl Estradiol | Tablet; Oral | SUPPL-6 | Lupin Ltd | Manufacturing (CMC) | Approved |
| Nikki
ANDA #201661 |
Drospirenone; Ethinyl Estradiol | Tablet; Oral | SUPPL-4 | Lupin Ltd | Labeling | Approved |
| Noxafil
NDA #022003 |
Posaconazole | Suspension; Oral | SUPPL-24 | Schering | Labeling | Approved |
| Noxafil
NDA #205053 |
Posaconazole | Tablet, Delayed Release; Oral | SUPPL-8 | Merck Sharp Dohme | Labeling | Approved |
| Noxafil
NDA #205596 |
Posaconazole | Solution; Intravenous | SUPPL-7 | Merck Sharp Dohme | Labeling | Approved |
| Potassium Chloride
ANDA #208445 |
Potassium Chloride | Capsule, Extended Release; Oral | ORIG-1 | Zydus Pharms Usa Inc | Approved | |
| Prochlorperazine Edisylate
ANDA #040540 |
Prochlorperazine Edisylate | Injectable; Injection | SUPPL-16 | Athenex Inc | Manufacturing (CMC) | Approved |
| Trazimera
BLA #761081 |
Trastuzumab-Qyyp | Injectable; Injection | ORIG-1 | Pfizer Inc | Approved |
March 10, 2019
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Aspirin and Dipyridamole
ANDA #206753 |
Aspirin; Dipyridamole | Capsule, Extended Release; Oral | SUPPL-2 | Zydus Pharms Usa Inc | Labeling | Approved |
| Aspirin and Dipyridamole
ANDA #206753 |
Aspirin; Dipyridamole | Capsule, Extended Release; Oral | SUPPL-2 | Zydus Pharms Usa Inc | Labeling | Approved |
| Aspirin and Dipyridamole
ANDA #209048 |
Aspirin; Dipyridamole | Capsule, Extended Release; Oral | SUPPL-1 | Dr Reddys Labs Ltd | Labeling | Approved |
| Aspirin and Dipyridamole
ANDA #209048 |
Aspirin; Dipyridamole | Capsule, Extended Release; Oral | SUPPL-1 | Dr Reddys Labs Ltd | Labeling | Approved |
| Entecavir
ANDA #206217 |
Entecavir | Tablet; Oral | SUPPL-5 | Aurobindo Pharma Ltd | Labeling | Approved |
| Entecavir
ANDA #206217 |
Entecavir | Tablet; Oral | SUPPL-2 | Aurobindo Pharma Ltd | Labeling | Approved |
| Entecavir
ANDA #206217 |
Entecavir | Tablet; Oral | SUPPL-5 | Aurobindo Pharma Ltd | Labeling | Approved |
| Entecavir
ANDA #206217 |
Entecavir | Tablet; Oral | SUPPL-6 | Aurobindo Pharma Ltd | Labeling | Approved |
| Entecavir
ANDA #206217 |
Entecavir | Tablet; Oral | SUPPL-7 | Aurobindo Pharma Ltd | Labeling | Approved |
| Torsemide
ANDA #076110 |
Torsemide | Tablet; Oral | SUPPL-6 | Teva | Labeling | Approved |
March 8, 2019
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Atenolol and Chlorthalidone
ANDA #210028 |
Atenolol; Chlorthalidone | Tablet; Oral | ORIG-1 | Zydus Pharms Usa Inc | Approved | |
| Folic Acid
ANDA #211064 |
Folic Acid | Tablet; Oral | ORIG-1 | Invatech Pharma | Approved | |
| Haldol
NDA #015923 |
Haloperidol Lactate | Injectable; Injection | SUPPL-95 | Janssen Pharms | Labeling | Approved |
| Haldol
NDA #018701 |
Haloperidol Decanoate | Injectable; Injection | SUPPL-73 | Janssen Pharms | Labeling | Approved |
| Hydrocodone Bitartrate and Acetaminophen
ANDA #211023 |
Acetaminophen; Hydrocodone Bitartrate | Solution; Oral | ORIG-1 | Wes Pharma Inc | Approved | |
| Parsabiv
NDA #208325 |
Etelcalcetide | Solution; Intravenous | SUPPL-2 | Kai Pharms Inc | Labeling | Approved |
| Pyridostigmine Bromide
ANDA #211694 |
Pyridostigmine Bromide | Syrup; Oral | ORIG-1 | Novitium Pharma | Approved | |
| Sporanox
NDA #020083 |
Itraconazole | Capsule; Oral | SUPPL-63 | Janssen Pharms | Labeling | Approved |
| Sporanox
NDA #020657 |
Itraconazole | Solution; Oral | SUPPL-37 | Janssen Pharms | Labeling | Approved |
| Tecentriq
BLA #761034 |
Atezolizumab | Injectable; Injection | SUPPL-18 | Genentech Inc | Efficacy | Approved |
| Tofacitinib
ANDA #209790 |
Tofacitinib | Unknown | ORIG-1 | Sun Pharm Inds Ltd | Tentative Approval |
March 7, 2019
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Abacavir; Dolutegravir; Lamivudine
ANDA #210899 |
Abacavir;Dolutegravir;Lamivudine | Unknown | ORIG-1 | Laurus Labs Ltd | Tentative Approval | |
| Imodium A-D
NDA #019860 |
Loperamide Hydrochloride | Tablet; Oral | SUPPL-33 | J and J Consumer Inc | Labeling | Approved |
| Opdivo
BLA #125554 |
Nivolumab | Injectable; Injection | SUPPL-42 | Bristol Myers Squibb | Efficacy | Approved |
March 6, 2019
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Atorvastatin Calcium
ANDA #204991 |
Atorvastatin Calcium | Tablet; Oral | ORIG-1 | Lupin Ltd | Approved | |
| Bumetanide
ANDA #202900 |
Bumetanide | Tablet; Oral | SUPPL-1 | Zydus Pharms Usa Inc | Labeling | Approved |
| Calcitriol
ANDA #211030 |
Calcitriol | Unknown | ORIG-1 | Gland Pharma Ltd | Tentative Approval | |
| Carvedilol
ANDA #078251 |
Carvedilol | Tablet; Oral | SUPPL-18 | Glenmark Generics | Labeling | Approved |
| Pioglitazone Hydrochloride and Metformin Hydrochloride
ANDA #204802 |
Metformin Hydrochloride; Pioglitazone Hydrochloride | Tablet; Oral | SUPPL-5 | Macleods Pharms Ltd | Labeling | Approved |
| Pioglitazone Hydrochloride and Metformin Hydrochloride
ANDA #204802 |
Metformin Hydrochloride; Pioglitazone Hydrochloride | Tablet; Oral | SUPPL-8 | Macleods Pharms Ltd | Labeling | Approved |
| Pioglitazone Hydrochloride and Metformin Hydrochloride
ANDA #204802 |
Metformin Hydrochloride; Pioglitazone Hydrochloride | Tablet; Oral | SUPPL-5 | Macleods Pharms Ltd | Labeling | Approved |
| Pioglitazone Hydrochloride and Metformin Hydrochloride
ANDA #204802 |
Metformin Hydrochloride; Pioglitazone Hydrochloride | Tablet; Oral | SUPPL-8 | Macleods Pharms Ltd | Labeling | Approved |
| Simvastatin
ANDA #078034 |
Simvastatin | Tablet; Oral | SUPPL-12 | Biocon Limited | Labeling | Approved |
| Sivextro
NDA #205435 |
Tedizolid Phosphate | Tablet; Oral | SUPPL-10 | Cubist Pharms Llc | Efficacy | Approved |
| Sivextro
NDA #205436 |
Tedizolid Phosphate | Powder; Intravenous | SUPPL-5 | Cubist Pharms Llc | Efficacy | Approved |
| Solifenacin Succinate
ANDA #211657 |
Solifenacin Succinate | Unknown | ORIG-1 | Sciegen Pharms Inc | Tentative Approval | |
| Tranexamic Acid
ANDA #201885 |
Tranexamic Acid | Injectable; Injection | SUPPL-6 | Luitpold | Labeling | Approved |
March 5, 2019
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Bepotastine Besilate
ANDA #206066 |
Bepotastine Besilate | Solution/Drops; Ophthalmic | ORIG-1 | Apotex Inc | Approved | |
| Clonidine Hydrochloride
ANDA #209675 |
Clonidine Hydrochloride | Tablet, Extended Release; Oral | ORIG-1 | Novast Labs | Approved | |
| Esomeprazole Magnesium
ANDA #209202 |
Esomeprazole Magnesium | Tablet, Delayed Release; Oral | ORIG-1 | Actavis Elizabeth | Approved | |
| Prevymis
NDA #209939 |
Letermovir | Tablet; Oral | SUPPL-3 | Merck Sharp Dohme | Labeling | Approved |
| Prevymis
NDA #209940 |
Letermovir | Solution; Intravenous | SUPPL-1 | Merck Sharp Dohme | Labeling | Approved |
| Spravato
NDA #211243 |
Esketamine | Spray; Nasal | ORIG-1 | Janssen Pharms | Type 2 - New Active Ingredient | Approved |
| Zykadia
NDA #205755 |
Ceritinib | Capsule; Oral | SUPPL-16 | Novartis Pharms Corp | Labeling | Approved |
March 4, 2019
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Aliskiren Hemifumarate; Hydrochlorothiazide
ANDA #205769 |
Aliskiren Hemifumarate;Hydrochlorothiazide | Unknown | ORIG-1 | Par Pharm Inc | Tentative Approval | |
| Clobetasol Propionate
ANDA #211800 |
Clobetasol Propionate | Ointment; Topical | ORIG-1 | Aleor Dermaceuticals | Approved | |
| Desvenlafaxine Succinate
ANDA #204003 |
Desvenlafaxine Succinate | Tablet, Extended Release; Oral | SUPPL-6 | Alembic Pharms Ltd | Labeling | Approved |
| Fulvestrant
ANDA #210044 |
Fulvestrant | Injectable; Intramuscular | ORIG-1 | Amneal Pharms Co | Approved | |
| Lupron Depot
NDA #019732 |
Leuprolide Acetate | Injectable; Injection | SUPPL-44 | Abbvie Endocrine Inc | Labeling | Approved |
| Lupron Depot
NDA #020517 |
Leuprolide Acetate | Injectable; Injection | SUPPL-42 | Abbvie Endocrine Inc | Labeling | Approved |
| Nuplazid
NDA #207318 |
Pimavanserin Tartrate | Tablet; Oral | SUPPL-6 | Acadia Pharms Inc | Labeling | Approved |
| Nuplazid
NDA #210793 |
Pimavanserin Tartrate | Capsule; Oral | SUPPL-1 | Acadia Pharms Inc | Labeling | Approved |
| Rivastigmine
ANDA #206318 |
Rivastigmine | Film, Extended Release; Transdermal | ORIG-1 | Zydus Noveltech Inc | Approved | |
| Telmisartan and Hydrochlorothiazide
ANDA #202544 |
Hydrochlorothiazide; Telmisartan | Tablet; Oral | ORIG-1 | Glenmark Pharms Ltd | Approved |
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English