| Product |
Company |
Generic name |
KEGG DRUG |
|
Nitrogen gas 992 mL/L (NDA)
|
Matheson Tri-Gas, Inc. |
Nitrogen |
D00083
|
|
TRIAMCINOLONE ACETONIDE cream 1 mg/g (ANDA)
|
REMEDYREPACK INC. |
triamcinolone acetonide |
D00983
|
Labetalol Hydrochloride tablet 100 mg (ANDA)
Labetalol Hydrochloride tablet 200 mg (ANDA)
Labetalol Hydrochloride tablet 300 mg (ANDA)
|
Chartwell RX, LLC |
Labetalol Hydrochloride |
D00600
|
|
Potassium Chloride Extended-release tablet, extended release 1500 mg (ANDA)
|
REMEDYREPACK INC. |
Potassium Chloride Extended-release |
D02060
|
|
TYENNE injection, solution 162 mg/.9mL (BLA)
|
Fresenius Kabi USA, LLC |
Tocilizumab-aazg |
D02596
|
Tizanidine HCl tablet 4 mg (ANDA)
Tizanidine HCl tablet 2 mg (ANDA)
|
Advanced Rx Pharmacy of Tennessee, LLC |
Tizanidine HCl |
D00776
|
|
Ammonia N 13 injection 260 mCi/mL (ANDA)
|
PETNET Solutions, Inc. |
Ammonia N-13 |
D02915
|
Isosorbide Mononitrate tablet, extended release 30 mg (ANDA)
Isosorbide Mononitrate tablet, extended release 60 mg (ANDA)
Isosorbide Mononitrate tablet, extended release 120 mg (ANDA)
|
Chartwell RX, LLC |
Isosorbide Mononitrate |
D00630
|
|
Ipratropium Bromide and Albuterol Sulfate solution 3 mg/3mL (ANDA)
|
Chartwell RX, LLC |
Ipratropium Bromide and Albuterol Sulfate |
D10256
|
|
NITROUS OXIDE gas 99 L00L (NDA)
|
Spectrum Gas Products, Inc |
NITROUS OXIDE |
D00102
|
Benztropine Mesylate tablet .5 mg (ANDA)
Benztropine Mesylate tablet 1 mg (ANDA)
Benztropine Mesylate tablet 2 mg (ANDA)
|
American Health Packaging |
Benztropine Mesylate |
D00778
|
|
Butorphanol Tartrate spray 10 mg/mL (ANDA)
|
Apotex Corp. |
Butorphanol Tartrate |
D00837
|
|
Pantoprazole Sodium tablet, delayed release 20 mg (ANDA)
|
AvPAK |
Pantoprazole Sodium |
D02593
|
|
Spironolactone tablet, coated 25 mg (ANDA)
|
A-S Medication Solutions |
Spironolactone |
D00443
|
Glycopyrrolate injection .2 mg/mL (ANDA)
Glycopyrrolate injection .4 mg/2mL (ANDA)
Glycopyrrolate injection 1 mg/5mL (ANDA)
Glycopyrrolate injection 4 mg/20mL (ANDA)
|
Amneal Pharmaceuticals LLC |
Glycopyrrolate |
D00540
|
VARENICLINE TARTRATE kit (ANDA)
VARENICLINE tablet, film coated .5 mg (ANDA)
VARENICLINE tablet, film coated 1 mg (ANDA)
|
Lupin Pharmaceuticals, Inc. |
VARENICLINE TARTRATE |
D06282
|
Methylprednisolone tablet 4 mg (ANDA)
Methylprednisolone tablet 8 mg (ANDA)
Methylprednisolone tablet 16 mg (ANDA)
Methylprednisolone tablet 32 mg (ANDA)
|
Amneal Pharmaceuticals LLC |
Methylprednisolone |
D00407
|
|
Sucralfate suspension 1 g0mL (ANDA)
|
AvKARE |
Sucralfate Oral |
D00446
|
|
Cotellic tablet, film coated 20 mg (NDA)
|
Genentech, Inc. |
COBIMETINIB |
D10615
|
ZYPITAMAG tablet, film coated 2 mg (NDA)
ZYPITAMAG tablet, film coated 4 mg (NDA)
|
Medicure International Inc |
Pitavastatin Magnesium |
D11092
|
|
Doxycycline Hyclate tablet, film coated 100 mg (ANDA)
|
A-S Medication Solutions |
Doxycycline Hyclate |
D02129
|
|
Fludeoxyglucose F 18 injection, solution 200 mCi/mL (ANDA)
|
PETNET Solutions, Inc. |
Fludeoxyglucose F 18 |
D01843
|
nitrofurantoin macrocrystals capsule 25 mg (ANDA)
nitrofurantoin macrocrystals capsule 50 mg (ANDA)
nitrofurantoin macrocrystals capsule 100 mg (ANDA)
|
BluePoint Laboratories |
nitrofurantoin macrocrystals |
D00439
|
|
naloxone hydrochloride injection, solution .4 mg/mL (ANDA)
|
Baxter Healthcare Corporation |
naloxone hydrochloride |
D11620
|
|
CHLORHEXIDINE GLUCONATE rinse 1.2 mg/mL (ANDA)
|
PAI Holdings, LLC dba PAI Pharma |
CHLORHEXIDINE GLUCONATE |
D00858
|
Procainamide Hydrochloride injection 100 mg/mL (ANDA)
Procainamide Hydrochloride injection 500 mg/mL (ANDA)
|
Nexus Pharmaceuticals LLC |
Procainamide Hydrochloride |
D00477
|
|
Dabigatran Etexilate capsule 150 mg (ANDA)
|
NorthStar RxLLC |
Dabigatran Etexilate |
D07082
|
|
Methotrexate Sodium tablet 2.5 mg (ANDA)
|
Hikma Pharmaceuticals USA Inc. |
Methotrexate Sodium |
D02115
|
AMJEVITA injection 20 mg/.2mL (BLA)
AMJEVITA injection 40 mg/.4mL (BLA)
AMJEVITA injection 80 mg/.8mL (BLA)
|
Optum Health Solutions (Ireland) Limited |
adalimumab-atto |
D02597
|
|
HYRNUO tablet, film coated 10 mg (NDA)
|
Bayer HealthCare Pharmaceuticals Inc. |
SEVABERTINIB |
D13116
|
|
Oxygen gas 992 mL/L (NDA)
|
Matheson Tri-Gas, Inc. |
Oxygen |
D00003
|
|
Azithromycin Dihydrate tablet, film coated 250 mg (ANDA)
|
Precision Dose, Inc. |
Azithromycin Dihydrate |
D02134
|
|
Prevalite powder, for suspension 4 g/5.5g (ANDA)
|
Upsher-Smith Laboratories, LLC |
cholestyramine |
D02690
|
POSACONAZOLE tablet, coated 100 mg (NDA AUTHORIZED GENERIC)
POSACONAZOLE suspension 40 mg/mL (NDA AUTHORIZED GENERIC)
|
ENDO USA, Inc. |
posaconazole |
D02555
|
|
Oxygen gas 992 mL/L (NDA)
|
BUCKEYE WELDING SUPPLY COMPANY, INC. |
Oxygen |
D00003
|
|
Amitriptyline Hydrochloride tablet, film coated 10 mg (ANDA)
|
ST. MARY'S MEDICAL PARK PHARMACY |
Amitriptyline Hydrochloride |
D00809
|
|
SIMVASTATIN tablet, film coated 40 mg (ANDA)
|
REMEDYREPACK INC. |
SIMVASTATIN |
D00434
|
|
Levetiracetam solution 100 mg/mL (ANDA)
|
Guardian Drug Company |
Levetiracetam |
D00709
|
|
Sucralfate suspension 1 g0mL (ANDA)
|
AvPAK |
Sucralfate Oral |
D00446
|
|
NITROGEN gas 99 L00L (NDA)
|
Spectrum Gas Products, Inc |
NITROGEN |
D00083
|