| Product |
Company |
Generic name |
KEGG DRUG |
|
Nafcillin injection, powder, lyophilized, for solution 2 g/8mL (ANDA)
|
Fresenius Kabi USA, LLC |
Nafcillin Sodium |
D00928
|
Solifenacin Succinate tablet, coated 5 mg (ANDA)
Solifenacin Succinate tablet, coated 10 mg (ANDA)
|
Alembic Pharmaceuticals Limited |
Solifenacin Succinate |
D01269
|
|
Ipratropium Bromide solution .5 mg/2.5mL (ANDA)
|
Mylan Pharmaceuticals Inc. |
Ipratropium Bromide |
D02212
|
|
Naproxen Sodium tablet, film coated, extended release 375 mg (NDA AUTHORIZED GENERIC)
|
SA3, LLC |
Naproxen Sodium |
D00970
|
|
COLLAGENASE SANTYL ointment 250 [arb'U]/g (BLA)
|
SMITH & NEPHEW, INC |
COLLAGENASE SANTYL |
D09596
|
Nafcillin injection, powder, lyophilized, for solution 1 g/4mL (ANDA)
Nafcillin injection, powder, lyophilized, for solution 2 g/8mL (ANDA)
|
Fresenius Kabi USA, LLC |
NAFCILLIN SODIUM |
D00928
|
|
IBU tablet 800 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC |
Ibuprofen |
D00126
|
|
Lisinopril and Hydrochlorothiazide tablet 20 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC |
Lisinopril and Hydrochlorothiazide |
D10268
|
Nitrofurantion capsule 25 mg (ANDA)
Nitrofurantion capsule 50 mg (ANDA)
Nitrofurantion capsule 100 mg (ANDA)
|
BluePoint Labortories |
Nitrofurantion |
D00439
|
|
Diazepam tablet 5 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC |
Diazepam |
D00293
|
|
verapamil hydrochloride tablet, film coated, extended release 240 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC |
verapamil hydrochloride |
D00619
|
|
LANOXIN tablet .125 mg (NDA)
|
Aphena Pharma Solutions - Tennessee, LLC |
digoxin |
D00298
|
|
Ipratropium Bromide and Albuterol Sulfate solution .5 mg/3mL (ANDA)
|
Mylan Pharmaceuticals Inc. |
Ipratropium Bromide and Albuterol Sulfate |
D10256
|
|
OLOPATADINE HYDROCHLORIDE solution/ drops 2 mg/mL (ANDA)
|
Alembic Pharmaceuticals Inc. |
olopatadine hydrochloride |
D01192
|
|
Hydralazine Hydrochloride injection, solution 20 mg/mL (ANDA)
|
American Regent, Inc. |
Hydralazine Hydrochloride |
D01302
|
|
Moxifloxacin Hydrochloride Tablets, 400 mg tablet, film coated 400 mg (ANDA)
|
Novadoz Pharmaceuticals LLC |
Moxifloxacin Hydrochloride Tablets, 400 mg |
D00874
|
|
Buspirone hydrochloride tablet 5 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC |
Buspirone hydrochloride |
D00702
|
|
Dicyclomine Hydrochloride capsule 10 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC |
Dicyclomine Hydrochloride |
D00717
|
|
RISPERIDONE tablet 2 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC |
RISPERIDONE |
D00426
|
|
ADSOL Red Cell Preservation Solution System in Plastic Container (PL 146 Plastic) kit (NDA)
|
Fenwal, Inc. |
Anticoagulant Citrate Phosphate Dextrose (CPD) Solution and ADSOL Preservation Solution |
D08745
|
VITRAKVI capsule 25 mg (NDA)
VITRAKVI capsule 100 mg (NDA)
VITRAKVI solution 20 mg/mL (NDA)
|
Loxo Oncology, Inc. |
LAROTRECTINIB |
D11138
|
|
Caffeine Citrate solution 20 mg/mL (ANDA)
|
Fresenius Kabi USA, LLC |
CAFFEINE CITRATE |
D07603
|
Buspirone Hydrochloride tablet 5 mg (ANDA)
Buspirone Hydrochloride tablet 7.5 mg (ANDA)
Buspirone Hydrochloride tablet 10 mg (ANDA)
Buspirone Hydrochloride tablet 15 mg (ANDA)
Buspirone Hydrochloride tablet 30 mg (ANDA)
|
Epic Pharma, LLC |
Buspirone Hydrochloride |
D00702
|
|
Risperidone tablet 2 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC |
Risperidone |
D00426
|
|
Sucralfate tablet 1 g (NDA AUTHORIZED GENERIC)
|
Aphena Pharma Solutions - Tennessee, LLC |
Sucralfate |
D00446
|
|
Tramadol Hydrochloride tablet, film coated 50 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC |
Tramadol Hydrochloride |
D01355
|
|
Orabloc injection 40 mg/mL (NDA)
|
Pierrel S.p.A. |
articaine hydrochloride and epinephrine bitartrate |
D11290
|
|
TEMAZEPAM capsule 7.5 mg (NDA)
|
Aphena Pharma Solutions - Tennessee, LLC |
temazepam |
D00370
|
|
simvastatin tablet, film coated 10 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC |
simvastatin |
D00434
|
|
Allopurinol tablet 300 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC |
Allopurinol |
D00224
|
|
Lorazepam tablet .5 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC |
Lorazepam |
D00365
|
|
Zolpidem Tartrate tablet, film coated, extended release 12.5 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC |
Zolpidem Tartrate |
D00706
|
|
Zoledronic Acid injection 4 mg00mL (ANDA)
|
Gland Pharma Limited |
zoledronic Acid |
D01968
|
Tadalafil tablet, film coated 2.5 mg (ANDA)
Tadalafil tablet, film coated 5 mg (ANDA)
Tadalafil tablet, film coated 10 mg (ANDA)
Tadalafil tablet, film coated 20 mg (ANDA)
|
Camber Pharmaceuticals, Inc. |
Tadalafil |
D02008
|
|
Triamterene and Hydrochlorothiazide capsule 37.5 mg (ANDA)
|
Zydus Pharmaceuticals (USA) Inc. |
Triamterene and Hydrochlorothiazide |
D10269
|
|
Intralipid emulsion 20 g00mL (NDA)
|
Baxter Healthcare Corporation |
I.V. Fat Emulsion |
D04962
|
Levofloxacin injection, solution 250 mg/50mL (ANDA)
Levofloxacin injection, solution 500 mg00mL (ANDA)
Levofloxacin injection, solution 750 mg50mL (ANDA)
|
Hikma Pharmaceuticals USA Inc. |
Levofloxacin |
D00588
|
Levofloxacin injection, solution 250 mg/50mL (ANDA)
Levofloxacin injection, solution 500 mg00mL (ANDA)
Levofloxacin injection, solution 750 mg50mL (ANDA)
|
Hikma Pharmaceuticals USA Inc. |
Levofloxacin |
D00588
|
|
Adenosine injection, solution 3 mg/mL (ANDA)
|
Fresenius Kabi USA, LLC |
Adenosine |
D00045
|
Metoprolol succinate tablet, extended release 100 mg (ANDA)
Metoprolol succinate tablet, extended release 200 mg (ANDA)
|
BluePoint Laboratories |
Metoprolol succinate |
D00635
|