| Product |
Company |
Generic name |
KEGG DRUG |
|
Prednisolone Sodium Phosphate solution 20 mg/5mL (ANDA)
|
PAI Holdings, LLC dba PAI Pharma |
Prednisolone Sodium Phosphate |
D00981
|
|
Midazolam Hydrochloride injection, solution 5 mg/mL (ANDA)
|
Belcher Pharmaceuticals, LLC |
Midazolam Hydrochloride |
D00696
|
|
Omega-3-Acid Ethyl Esters capsule 1 g (ANDA)
|
KD Pharma USA, Inc. |
Omega-3-Acid Ethyl Esters |
D05255
|
|
Budesonide Inhalation Suspension inhalant .5 mg/2mL (ANDA)
|
Preferred Pharmaceuticals Inc. |
Budesonide |
D00246
|
|
Perforomist solution 20 ug/2mL (NDA)
|
Viatris Specialty LLC |
formoterol fumarate dihydrate |
D05277
|
Crenessity capsule 25 mg (NDA)
Crenessity capsule 50 mg (NDA)
Crenessity capsule 100 mg (NDA)
Crenessity solution 50 mg/mL (NDA)
|
Neurocrine Biosciences, Inc. |
crinecerfont |
D12366
|
|
Estradiol Valerate and Estradiol Valerate/Dienogest kit (NDA AUTHORIZED GENERIC)
|
Sandoz Inc |
estradiol valerate and estradiol valerate/dienogest |
D10461
|
|
NITROGEN gas 99 L00L (NDA)
|
Crumpton Welding Supply & Equipment, Inc. |
NITROGEN |
D00083
|
|
Linezolid powder, for suspension 100 mg/5mL (ANDA)
|
Hikma Pharmaceuticals USA Inc. |
linezolid |
D00947
|
|
Folic Acid tablet 1 mg (ANDA)
|
Coupler LLC |
Folic Acid |
D00070
|
|
Prednisone tablet 2.5 mg (ANDA)
|
Coupler LLC |
Prednisone |
D00473
|
|
Promethazine Hydrochloride tablet 50 mg (ANDA)
|
Coupler LLC |
Promethazine Hydrochloride |
D00480
|
|
ISOSORBIDE MONONITRATE tablet, extended release 30 mg (ANDA)
|
Coupler LLC |
ISOSORBIDE MONONITRATE |
D00630
|
|
tizanidine tablet 4 mg (ANDA)
|
Coupler LLC |
tizanidine |
D00776
|
|
Chlorhexidine Gluconate, 0.12% Oral Rinse Solution solution 1.2 mg/mL (ANDA)
|
Kesin Pharma Corporation |
Chlorhexidine Gluconate, 0.12% Oral Rinse |
D00858
|
|
Anastrozole tablet, coated 1 mg (ANDA)
|
BluePoint Laboratories |
Anastrozole |
D00960
|
|
Icatibant injection, solution 10 mg/mL (ANDA)
|
Teva Pharmaceuticals USA, Inc. |
Icatibant |
D04492
|
|
Clobetasol Propionate spray .5 mg/mL (ANDA)
|
Macleods Pharmaceuticals Limited |
Clobetasol Propionate |
D01272
|
Fondaparinux Sodium injection, solution 2.5 mg/.5mL (NDA AUTHORIZED GENERIC)
Fondaparinux Sodium injection, solution 5 mg/.4mL (NDA AUTHORIZED GENERIC)
Fondaparinux Sodium injection, solution 7.5 mg/.6mL (NDA AUTHORIZED GENERIC)
Fondaparinux Sodium injection, solution 10 mg/.8mL (NDA AUTHORIZED GENERIC)
|
Mylan Institutional LLC |
fondaparinux sodium |
D01844
|
|
TRI-LO-MARZIA kit (ANDA)
|
A-S Medication Solutions |
norgestimate and ethinyl estradiol |
D10590
|
Metformin HCl tablet, film coated 1000 mg (ANDA)
Metformin HCl tablet, film coated 850 mg (ANDA)
Metformin HCl tablet, film coated 500 mg (ANDA)
|
TIME CAP LABORATORIES, INC |
Metformin HCl |
D00944
|
|
Diclofenac Sodium solution 16.05 mg/mL (ANDA)
|
Asclemed USA, Inc. |
Diclofenac Sodium |
D00904
|
|
Quetiapine Fumarate tablet 25 mg (ANDA)
|
Preferred Pharmaceuticals Inc. |
Quetiapine Fumarate |
D00458
|
|
Promethazine Hydrochloride tablet 25 mg (ANDA)
|
NuCare Pharmaceuticals,Inc. |
Promethazine Hydrochloride |
D00480
|
|
Albuterol Sulfate solution 2.5 mg/3mL (ANDA)
|
NuCare Pharmaceuticals,Inc. |
Albuterol Sulfate |
D00683
|
EPIPEN injection .3 mg/.3mL (NDA)
EPIPEN JR injection .15 mg/.3mL (NDA)
|
Viatris Specialty LLC |
epinephrine |
D00095
|
|
Sumatriptan Succinate tablet 50 mg (ANDA)
|
NuCare Pharmaceuticals,Inc. |
Sumatriptan Succinate |
D00676
|
|
SYMFI tablet, film coated 600 mg (NDA)
|
Viatris Specialty LLC |
Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate |
D11392
|
|
Dicyclomine Hydrochloride tablet 20 mg (ANDA)
|
Bryant Ranch Prepack |
Dicyclomine Hydrochloride |
D00717
|
OXERVATE kit (BLA)
OXERVATE solution/ drops 20 ug/mL (BLA)
|
Dompé farmaceutici S.p.A. |
cenegermin-bkbj |
D11028
|
|
OXYGEN gas 99 L00L (NDA)
|
Crumpton Welding Supply & Equipment, Inc. |
OXYGEN |
D00003
|
|
Zithromax injection, powder, lyophilized, for solution 500 mg/5mL (NDA)
|
Pfizer Laboratories Div Pfizer Inc |
azithromycin dihydrate |
D02134
|
|
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE tablet 325 mg (ANDA)
|
Preferred Pharmaceuticals Inc. |
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE |
D11850
|
|
EBANGA kit (BLA)
|
Ridgeback Biotherapeutics, LP |
ANSUVIMAB |
D11875
|
|
Levothyroxine Sodium tablet .175 mg (ANDA)
|
Preferred Pharmaceuticals Inc. |
Levothyroxine Sodium |
D01010
|
|
Levothyroxine sodium tablet 88 ug (ANDA)
|
Preferred Pharmaceuticals Inc. |
Levothyroxine sodium |
D01010
|
|
VENTOLIN HFA aerosol, metered 90 ug (NDA)
|
A-S Medication Solutions |
albuterol sulfate |
D00683
|
|
Diclofenac Sodium tablet, delayed release 50 mg (ANDA)
|
Bryant Ranch Prepack |
Diclofenac Sodium |
D00904
|
|
Dexamethasone tablet 4 mg (ANDA)
|
Preferred Pharmaceuticals Inc. |
Dexamethasone |
D00292
|
|
Tadalafil tablet, film coated 20 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC |
Tadalafil |
D02008
|