| Product |
Company |
Generic name |
KEGG DRUG |
|
Air gas 210 mL/L (NDA)
|
SYOXSA, Inc. |
Air |
D03043
|
|
TEVIMBRA injection, solution, concentrate 10 mg/mL (BLA)
|
BeOne Medicines USA, Inc. |
tislelizumab-jsgr |
D11487
|
|
FOSAMAX PLUS D tablet 70 mg (NDA)
|
Organon LLC |
ALENDRONATE SODIUM and CHOLECALCIFEROL |
D10841
|
|
OXLUMO injection, solution 94.5 mg/.5mL (NDA)
|
Alnylam Pharmaceuticals, Inc. |
lumasiran |
D11926
|
|
Albuterol Sulfate inhalant 90 ug (ANDA)
|
Armstrong Pharmaceuticals, Inc. |
Albuterol Sulfate |
D00683
|
Exforge HCT tablet, film coated 5 mg (NDA)
Exforge HCT tablet, film coated 10 mg (NDA)
|
Novartis Pharmaceuticals Corporation |
amlodipine valsartan and hydrochlorothiazide |
D10286
|
Simulect injection, powder, for solution 20 mg/5mL (BLA)
Simulect injection, powder, for solution 10 mg/2.5mL (BLA)
|
Novartis Pharmaceuticals Corporation |
basiliximab |
D03058
|
|
Sildenafil tablet, film coated 50 mg (ANDA)
|
NuCare Pharmaceuticals, Inc. |
Sildenafil |
D02229
|
|
LABETALOL HYDROCHLORIDE tablet, film coated 100 mg (ANDA)
|
Redpharm Drug |
Labetalol Hydrochloride |
D00600
|
|
Nifedipine tablet, extended release 30 mg (ANDA)
|
Redpharm Drug |
Nifedipine |
D00437
|
|
Oxygen gas 995 mL/L (NDA)
|
SYOXSA, Inc. |
Oxygen |
D00003
|
|
Ketorolac Tromethamine tablet, film coated 10 mg (ANDA)
|
Redpharm Drug |
ketorolac tromethamine |
D00813
|
|
Acyclovir tablet 400 mg (ANDA)
|
Redpharm Drug |
Acyclovir |
D00222
|
|
Potassium Chloride Extended-release tablet, extended release 1500 mg (ANDA)
|
Redpharm Drug |
Potassium Chloride Extended-release |
D02060
|
|
Dicyclomine hydrochloride capsule 10 mg (ANDA)
|
Redpharm Drug |
Dicyclomine hydrochloride |
D00717
|
|
OFLOXACIN solution 3 mg/mL (ANDA)
|
Redpharm Drug |
OFLOXACIN |
D00453
|
|
meloxicam tablet 7.5 mg (ANDA)
|
PHOENIX RX LLC |
meloxicam |
D00969
|
|
Emtricitabine and tenofovir disoproxil fumarate tablet, film coated 200 mg (ANDA)
|
Redpharm Drug |
Emtricitabine and tenofovir disoproxil fumarate |
D02297
|
|
PREDNISONE tablet 20 mg (ANDA)
|
Redpharm Drug |
PREDNISONE |
D00473
|
|
Buspirone hydrochloride tablet 15 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC |
Buspirone hydrochloride |
D00702
|
|
Baclofen tablet 20 mg (ANDA)
|
PHOENIX RX LLC |
Baclofen |
D00241
|
|
Moxifloxacin tablet, film coated 400 mg (ANDA)
|
Solaris Pharma Corporation |
moxifloxacin hydrochloride |
D00874
|
|
JUBBONTI injection 60 mg/mL (BLA)
|
Sandoz Inc |
denosumab |
D03684
|
Amantadine Hydrochloride solution 50 mg/5mL (ANDA)
Amantadine Hydrochloride solution 100 mg0mL (ANDA)
|
Chartwell RX, LLC |
Amantadine Hydrochloride |
D00777
|
|
propofol injection, emulsion 10 mg/mL (ANDA)
|
Meitheal Pharmaceuticals Inc. |
propofol |
D00549
|
|
RISPERIDONE tablet 2 mg (ANDA)
|
REMEDYREPACK INC. |
RISPERIDONE |
D00426
|
Aplenzin tablet, extended release 174 mg (NDA)
Aplenzin tablet, extended release 348 mg (NDA)
Aplenzin tablet, extended release 522 mg (NDA)
|
Bausch Health US, LLC |
bupropion hydrobromide |
D07938
|
|
Nitrogen gas 990 mL/L (NDA)
|
SYOXSA, Inc. |
Nitrogen |
D00083
|
MELOXICAM tablet 7.5 mg (ANDA)
MELOXICAM tablet 15 mg (ANDA)
|
XLCare Pharmaceuticals, Inc. |
meloxicam |
D00969
|
INOMAX gas .98 mg/L (NDA)
INOMAX gas 6 mg/L (NDA)
|
INO Therapeutics LLC |
nitric oxide |
D00074
|
|
Chenodal tablet, film coated 250 mg (ANDA)
|
Travere Therapeutics |
Chenodiol |
D00163
|
|
Haloperidol solution, concentrate 2 mg/mL (ANDA)
|
Advagen Pharma Ltd |
Haloperidol |
D00136
|
|
Valproate Sodium injection, solution 100 mg/mL (ANDA)
|
Sagent Pharmaceuticals |
Valproate Sodium |
D00710
|
|
Curosurf suspension 80 mg/mL (BLA)
|
Chiesi USA, Inc. |
poractant alfa |
D08402
|
|
IBU tablet 600 mg (ANDA)
|
Proficient Rx LP |
Ibuprofen |
D00126
|
|
Glipizide and Metformin HCl tablet, film coated 5 mg (ANDA)
|
REMEDYREPACK INC. |
Glipizide and Metformin HCl |
D10265
|
|
Albuterol Sulfate solution 2.5 mg/3mL (ANDA)
|
Ritedose Pharmaceuticals, LLC |
Albuterol Sulfate |
D00683
|
|
EXPAREL injection, suspension, liposomal 13.3 mg/mL (NDA)
|
Pacira Pharmaceuticals, Inc. |
bupivacaine |
D07552
|
|
IPRATROPIUM BROMIDE spray, metered 42 ug (ANDA)
|
Advagen Pharma Ltd |
IPRATROPIUM BROMIDE |
D02212
|
|
Theophylline Anhydrous tablet, extended release 400 mg (ANDA)
|
Rhodes Pharmaceuticals L.P. |
Theophylline |
D00371
|