| Product |
Company |
Generic name |
KEGG DRUG |
IMITREX injection 6 mg/.5mL (NDA)
IMITREX injection 4 mg/.5mL (NDA)
|
GlaxoSmithKline LLC |
sumatriptan |
D00676
|
|
ADCIRCA tablet 20 mg (NDA)
|
United Therapeutics Corporation |
Tadalafil |
D02008
|
|
ZYKADIA tablet, film coated 150 mg (NDA)
|
Novartis Pharmaceuticals Corporation |
ceritinib |
D10551
|
Prednisone delayed release tablet, delayed release 1 mg (ANDA)
Prednisone delayed release tablet, delayed release 2 mg (ANDA)
|
Dr. Reddys Laboratories Inc. |
Prednisone |
D00473
|
|
SEVELAMER CARBONATE tablet 800 mg (ANDA)
|
AiPing Pharmaceutical, Inc. |
SEVELAMER CARBONATE |
D06642
|
|
Amoxicillin and Clavulanate Potassium tablet, film coated, extended release 562.5 mg (NDA AUTHORIZED GENERIC)
|
USAntibiotics, LLC |
amoxicillin and clavulanate potassium |
D06485
|
Pregabalin capsule 25 mg (ANDA)
Pregabalin capsule 50 mg (ANDA)
Pregabalin capsule 75 mg (ANDA)
Pregabalin capsule 100 mg (ANDA)
Pregabalin capsule 150 mg (ANDA)
Pregabalin capsule 200 mg (ANDA)
Pregabalin capsule 300 mg (ANDA)
|
NorthStar RxLLC |
Pregabalin |
D02716
|
|
Diphenhydramine Hydrochloride injection 50 mg/mL (ANDA)
|
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. |
Diphenhydramine Hydrochloride |
D00669
|
|
Air gas 210 mL/L (NDA)
|
SYOXSA, Inc. |
Air |
D03043
|
|
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
|
|
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
|
|
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
|
|
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
|