| Product |
Company |
Generic name |
KEGG DRUG |
|
OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE tablet 25 mg (ANDA)
|
A-S Medication Solutions |
olmesartan medoxomil and hydrochlorothiazide |
D10284
|
|
epinephrine injection, solution 64 ug/mL (NDA)
|
Baxter Healthcare Corporation |
epinephrine |
D02149
|
|
Isosorbide Mononitrate tablet, extended release 120 mg (ANDA)
|
Edenbridge Pharmaceuticals LLC. |
Isosorbide Mononitrate |
D00630
|
|
Ilaris injection, solution 150 mg/mL (BLA)
|
Novartis Pharmaceuticals Corporation |
canakinumab |
D09315
|
|
NYSTATIN cream 100000 [USP'U]/g (ANDA)
|
Aurobindo Pharma Limited |
NYSTATIN |
D00202
|
Dextrose injection, solution 5 g00mL (NDA)
Dextrose injection, solution 10 g00mL (NDA)
|
ICU Medical, Inc. |
dextrose monohydrate |
D02325
|
|
Dulera aerosol 5 ug (NDA)
|
Organon LLC |
mometasone furoate and formoterol fumarate dihydrate |
D10295
|
|
Amoxicillin and Clavulanate Potassium tablet, film coated 875 mg (ANDA)
|
A-S Medication Solutions |
Amoxicillin and Clavulanate Potassium |
D06485
|
Neoral capsule, liquid filled 25 mg (NDA)
Neoral capsule, liquid filled 100 mg (NDA)
Neoral solution 100 mg/mL (NDA)
|
Novartis Pharmaceuticals Corporation |
cyclosporine |
D00184
|
FERRIPROX tablet 1000 mg (NDA)
FERRIPROX tablet, film coated 1000 mg (NDA)
FERRIPROX tablet, film coated 500 mg (NDA)
|
Chiesi USA, Inc. |
deferiprone |
D07416
|
|
Esmolol Hydrochloride injection, solution 10 mg/mL (ANDA)
|
Henry Schein, Inc. |
esmolol hydrochloride |
D00644
|
|
PRECEDEX injection, solution, concentrate 100 ug/mL (NDA)
|
Henry Schein, Inc. |
DEXMEDETOMIDINE HYDROCHLORIDE |
D01205
|
|
Buspirone Hydrochloride tablet 10 mg (ANDA)
|
Bryant Ranch Prepack |
buspirone hydrochloride |
D00702
|
|
Methylergonovine Maleate tablet .2 mg (ANDA)
|
Amneal Pharmaceuticals NY LLC |
Methylergonovine |
D00680
|
|
Valacyclovir Hydrochloride tablet, film coated 500 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc. |
Valacyclovir Hydrochloride |
D00398
|
Amoxicillin and Clavulanate Potassium tablet, film coated 875 mg (ANDA)
Amoxicillin and Clavulanate Potassium tablet, film coated 500 mg (ANDA)
|
A-S Medication Solutions |
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 225 mg (ANDA)
Pregabalin capsule 300 mg (ANDA)
|
MARKSANS PHARMA LIMITED |
Pregabalin |
D02716
|
|
Potassium Chloride in Dextrose and Sodium Chloride injection, solution 5 g00mL (NDA)
|
Baxter Healthcare Company |
Potassium Chloride, Dextrose Monohydrate and Sodium Chloride |
|
|
Tobramycin solution 300 mg/5mL (ANDA)
|
Teva Pharmaceuticals USA, Inc. |
Tobramycin |
D00063
|
|
Cephalexin capsule 500 mg (ANDA)
|
REMEDYREPACK INC. |
Cephalexin |
D00906
|
|
LISINOPRIL tablet 20 mg (ANDA)
|
A-S Medication Solutions |
Lisinopril |
D00362
|
|
Phenylephrine Hydrochloride injection 10 mg/mL (ANDA)
|
Henry Schein, Inc. |
Phenylephrine Hydrochloride |
D00511
|
Xofluza granule, for solution 40 mg/20mL (NDA)
Xofluza tablet, film coated 40 mg (NDA)
Xofluza tablet, film coated 80 mg (NDA)
Xofluza granule, for suspension 30 mg (NDA)
Xofluza granule, for suspension 40 mg (NDA)
|
Genentech, Inc. |
BALOXAVIR MARBOXIL |
D11021
|
Magnesium Sulfate injection, solution 2 g/50mL (ANDA)
Magnesium Sulfate injection, solution 4 g00mL (ANDA)
Magnesium Sulfate injection, solution 4 g/50mL (ANDA)
|
Baxter Healthcare Corporation |
Magnesium Sulfate Heptahydrate |
D01108
|
|
Methocarbamol tablet, coated 500 mg (ANDA)
|
A-S Medication Solutions |
Methocarbamol Tablets |
D00402
|
|
Silver Sulfadiazine cream 10 mg/g (NDA)
|
A-S Medication Solutions |
Silver Sulfadiazine |
D00433
|
Dextrose injection 5 g00mL (NDA)
Dextrose injection 2.5 g/50mL (NDA)
|
Baxter Healthcare Company |
dextrose monohydrate |
D02325
|
|
Cortrosyn injection, powder, lyophilized, for solution .25 mg/mL (NDA)
|
Henry Schein, Inc. |
Cortrosyn |
D00284
|
Naproxen tablet 250 mg (ANDA)
Naproxen tablet 375 mg (ANDA)
Naproxen tablet 500 mg (ANDA)
|
Aurobindo Pharma Limited |
Naproxen |
D00118
|
|
Acetaminophen injection, solution 10 mg/mL (ANDA)
|
Baxter Healthcare Corporation |
Acetaminophen |
D00217
|
Paroxetine tablet, film coated 10 mg (ANDA)
Paroxetine tablet, film coated 20 mg (ANDA)
Paroxetine tablet, film coated 30 mg (ANDA)
Paroxetine tablet, film coated 40 mg (ANDA)
|
NorthStar Rx LLC |
Paroxetine Hydrochloride |
D02260
|
|
Calcium Acetate capsule 667 mg (ANDA)
|
Westminster Pharmaceuticals, LLC |
Calcium Acetate |
D00931
|
Lanthanum carbonate tablet, chewable 500 mg (ANDA)
Lanthanum carbonate tablet, chewable 750 mg (ANDA)
Lanthanum carbonate tablet, chewable 1000 mg (ANDA)
|
Exelan Pharmaceuticals, Inc. |
LANTHANUM CARBONATE |
D04667
|
Estradiol gel .25 mg/.25g (ANDA)
Estradiol gel .5 mg/.5g (ANDA)
Estradiol gel 1 mg/g (ANDA)
Estradiol gel .75 mg/.75g (ANDA)
Estradiol gel 1.25 mg.25g (ANDA)
|
Xiromed, LLC |
Estradiol Gel 0.1% |
D00105
|
|
Methadone Hydrochloride injection 10 mg/mL (ANDA)
|
Hikma Pharmaceuticals USA Inc. |
Methadone Hydrochloride |
D02102
|
|
MAGNESIUM SULFATE IN DEXTROSE injection, solution 10 mg/mL (ANDA)
|
Baxter Healthcare Corporation |
magnesium sulfate in dextrose |
D01108
|
Lanthanum carbonate tablet, chewable 500 mg (ANDA)
Lanthanum carbonate tablet, chewable 750 mg (ANDA)
Lanthanum carbonate tablet, chewable 1000 mg (ANDA)
|
Cipla USA Inc. |
LANTHANUM CARBONATE |
D04667
|
|
Clonazepam tablet .5 mg (ANDA)
|
REMEDYREPACK INC. |
Clonazepam |
D00280
|
|
MESALAMINE tablet, delayed release 1.2 g (ANDA)
|
Lannett Company Inc. |
mesalamine |
D00377
|
|
ZOLPIDEM TARTRATE tablet 5 mg (ANDA)
|
REMEDYREPACK INC. |
zolpidem tartrate |
D00706
|