| Product |
Company |
Generic name |
KEGG DRUG |
CHOLBAM capsule 50 mg (NDA)
CHOLBAM capsule 250 mg (NDA)
|
Mirum Pharmaceuticals Inc. |
cholic acid |
D10699
|
|
PULMICORT FLEXHALER aerosol, powder 180 ug (NDA)
|
A-S Medication Solutions |
Budesonide |
D00246
|
|
Gentamicin injection, solution 40 mg/mL (ANDA)
|
Eugia US LLC |
Gentamicin |
D01063
|
Telmisartan tablet 20 mg (ANDA)
Telmisartan tablet 40 mg (ANDA)
Telmisartan tablet 80 mg (ANDA)
|
Macleods Pharmaceuticals Limited |
Telmisartan |
D00627
|
|
topiramate tablet, film coated 200 mg (ANDA)
|
Preferred Pharmaceuticals Inc. |
topiramate |
D00537
|
|
Amoxicillin tablet, coated 875 mg (ANDA)
|
Preferred Pharmaceuticals Inc. |
Amoxicillin |
D00229
|
SUMATRIPTAN spray 20 mg (ANDA)
SUMATRIPTAN spray 5 mg (ANDA)
|
Padagis Israel Pharmaceuticals Ltd |
sumatriptan |
D00451
|
|
Labetalol Hydrochloride tablet, film coated 200 mg (ANDA)
|
Bryant Ranch Prepack |
Labetalol Hydrochloride |
D00600
|
Prucalopride tablet, film coated 1 mg (ANDA)
Prucalopride tablet, film coated 2 mg (ANDA)
|
SpecGx LLC |
Prucalopride |
D10152
|
|
Amoxicillin and Clavulanate Potassium tablet, film coated 875 mg (ANDA)
|
NuCare Pharmaceuticals,Inc. |
Amoxicillin and Clavulanate Potassium |
D06485
|
|
venlafaxine tablet 100 mg (ANDA)
|
REMEDYREPACK INC. |
venlafaxine hydrochloride |
D00821
|
|
Lamotrigine tablet 150 mg (ANDA)
|
REMEDYREPACK INC. |
Lamotrigine |
D00354
|
|
Mirtazapine tablet, film coated 15 mg (ANDA)
|
REMEDYREPACK INC. |
Mirtazapine |
D00563
|
|
colesevelam hydrochloride tablet, film coated 625 mg (ANDA)
|
Glenmark Pharmaceuticals Inc., USA |
colesevelam hydrochloride |
D03582
|
|
Sulfasalazine tablet 500 mg (NDA AUTHORIZED GENERIC)
|
REMEDYREPACK INC. |
Sulfasalazine |
D00448
|
|
Metformin Hydrochloride tablet, film coated 1000 mg (ANDA)
|
A-S Medication Solutions |
Metformin Hydrochloride |
D00944
|
|
SIMVASTATIN tablet, film coated 20 mg (ANDA)
|
Proficient Rx LP |
SIMVASTATIN |
D00434
|
|
MARLISSA kit (ANDA)
|
Glenmark Pharmaceuticals Inc., USA |
Levonorgestrel and Ethinyl Estradiol |
D04482
|
FERRIPROX tablet 1000 mg (NDA)
FERRIPROX tablet, film coated 1000 mg (NDA)
|
Chiesi USA, Inc. |
DEFERIPRONE |
D07416
|
Felbamate tablet 400 mg (ANDA)
Felbamate tablet 600 mg (ANDA)
|
Viona Pharmaceuticals Inc |
Felbamate |
D00536
|
|
OSELTAMIVIR PHOSPHATE capsule 75 mg (ANDA)
|
Preferred Pharmaceuticals Inc. |
oseltamivir phosphate |
D00900
|
Deferasirox tablet, for suspension 125 mg (ANDA)
Deferasirox tablet, for suspension 250 mg (ANDA)
Deferasirox tablet, for suspension 500 mg (ANDA)
|
Novadoz Pharmaceuticals LLC |
Deferasirox |
D03669
|
|
prednisone tablet 1 mg (ANDA)
|
Strides Pharma Science Limited |
PREDNISONE |
D00473
|
|
IBANDRONATE SODIUM tablet, film coated 150 mg (ANDA)
|
Macleods Pharmaceuticals Limited |
IBANDRONATE SODIUM |
D04486
|
zolmiptriptan tablet, orally disintegrating 2.5 mg (ANDA)
zolmiptriptan tablet, orally disintegrating 5 mg (ANDA)
|
Glenmark Pharmaceuticals Inc., USA |
zolmitriptan |
D00415
|
|
Glyburide and Metformin Hydrochloride tablet, film coated 5 mg (ANDA)
|
Northwind Health Company, LLC |
Glyburide and Metformin Hydrochloride |
D10266
|
|
Verapamil Hydrochloride tablet, film coated 120 mg (ANDA)
|
Northwind Health Company, LLC |
Verapamil Hydrochloride |
D00619
|
|
Charlotte 24Fe kit (ANDA)
|
Glenmark Pharmaceuticals Inc., USA |
norethindrone acetate and ethinyl estradiol and ferrous fumarate |
D04483
|
|
venlafaxine tablet 50 mg (ANDA)
|
REMEDYREPACK INC. |
venlafaxine hydrochloride |
D00821
|
Buprenorphine HCl tablet 2 mg (ANDA)
Buprenorphine HCl tablet 8 mg (ANDA)
|
Camber Pharmaceuticals, Inc. |
Buprenorphine HCl |
D00836
|
|
PRAVASTATIN SODIUM tablet 80 mg (ANDA)
|
Bryant Ranch Prepack |
PRAVASTATIN SODIUM |
D00893
|
|
Cefazolin injection, powder, for solution 10 g (ANDA)
|
Civica, Inc. |
Cefazolin |
D00905
|
|
Alendronate Sodium solution 70 mg/75mL (ANDA)
|
Hikma Pharmaceuticals USA Inc. |
Alendronate Sodium |
D00939
|
|
Digoxin tablet .25 mg (ANDA)
|
A-S Medication Solutions |
Digoxin |
D00298
|
|
Amlodipine and Benazepril Hydrochloride capsule 5 mg (ANDA)
|
REMEDYREPACK INC. |
Amlodipine and Benazepril Hydrochloride |
D11069
|
|
Tobramycin and Dexamethasone suspension/ drops 3 mg/mL (ANDA)
|
A-S Medication Solutions |
Tobramycin and Dexamethasone |
D11178
|
Norethindrone Acetate and Ethinyl Estradiol tablet .5 mg (ANDA)
Norethindrone Acetate and Ethinyl Estradiol tablet 1 mg (ANDA)
|
Glenmark Pharmaceuticals Inc., USA |
Norethindrone Acetate and Ethinyl Estradiol |
D04483
|
Naproxen tablet 500 mg (ANDA)
Naproxen tablet 375 mg (ANDA)
|
A-S Medication Solutions |
Naproxen |
D00118
|
|
Norethindrone Acetate tablet 5 mg (ANDA)
|
Glenmark Pharmaceuticals Inc., USA |
Norethindrone Acetate |
D00953
|
|
MARCAINE WITH EPINEPHRINE injection, solution 2.5 mg/mL (NDA)
|
Henry Schein, Inc. |
bupivacaine hydrochloride and epinephrine bitartrate |
D11569
|