| Product |
Company |
Generic name |
KEGG DRUG |
|
TADALAFIL tablet 5 mg (ANDA)
|
Asclemed USA, Inc. |
TADALAFIL |
D02008
|
|
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE tablet 325 mg (ANDA)
|
QUAGEN PHARMACEUTICALS LLC |
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE |
D11850
|
|
BUTALBITAL and ACETAMINOPHEN tablet 325 mg (ANDA)
|
QUAGEN PHARMACEUTICALS LLC |
BUTALBITAL and ACETAMINOPHEN |
D11561
|
Metoprolol Tartrate tablet, film coated 25 mg (ANDA)
Metoprolol Tartrate tablet, film coated 50 mg (ANDA)
Metoprolol Tartrate tablet, film coated 100 mg (ANDA)
|
Rising Pharma Holdings, Inc. |
Metoprolol Tartrate |
D00601
|
Valsartan and Hydrochlorothiazide tablet, film coated 12.5 mg (ANDA)
Valsartan and Hydrochlorothiazide tablet, film coated 25 mg (ANDA)
|
Mylan Pharmaceuticals Inc. |
valsartan and hydrochlorothiazide |
D09197
|
TAZICEF injection, powder, for solution 1 g (ANDA)
TAZICEF injection, powder, for solution 2 g (ANDA)
|
Hospira, Inc. |
CEFTAZIDIME |
D00921
|
Sunitinib Malate capsule 12.5 mg (ANDA)
Sunitinib Malate capsule 25 mg (ANDA)
Sunitinib Malate capsule 50 mg (ANDA)
Sunitinib Malate capsule 37.5 mg (ANDA)
|
Mylan Pharmaceuticals Inc. |
sunitinib malate |
D06402
|
|
Kionex suspension 15 g/60mL (ANDA)
|
ANI Pharmaceuticals, Inc. |
Sodium Polystyrene Sulfonate |
D03263
|
Glyburide and Metformin Hydrochloride tablet, film coated 1.25 mg (ANDA)
Glyburide and Metformin Hydrochloride tablet, film coated 2.5 mg (ANDA)
Glyburide and Metformin Hydrochloride tablet, film coated 5 mg (ANDA)
|
Aurobindo Pharma Limited |
Glyburide and Metformin Hydrochloride |
D10266
|
|
COMBOGESIC IV injection 1000 mg00mL (NDA)
|
Hikma Pharmaceuticals USA Inc. |
acetaminophen and ibuprofen injection |
D11897
|
|
BRIELLYN kit (ANDA)
|
Glenmark Pharmaceuticals Inc., USA |
Norethindrone and Ethinyl Estradiol |
D04483
|
|
Metformin Hydrochloride tablet 1000 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc. |
Metformin Hydrochloride |
D00944
|
Rasagiline tablet .5 mg (ANDA)
Rasagiline tablet 1 mg (ANDA)
|
Chartwell RX, LLC |
Rasagiline |
D02562
|
|
Loperamide Hydrochloride capsule 2 mg (ANDA)
|
NuCare Pharmaceuticals,Inc. |
Loperamide Hydrochloride |
D00729
|
|
Lactated Ringers injection, solution .02 g00mL (NDA)
|
Asclemed USA, Inc. |
Sodium Chloride, Sodium Lactate, Potassium Chloride, and Calcium Chloride |
|
|
Adalimumab-adbm kit (BLA)
|
QUALLENT PHARMACEUTICALS HEALTH LLC |
Adalimumab-adbm |
D02597
|
|
PHENYLEPHRINE HYDROCHLORIDE injection 10 mg/mL (ANDA)
|
Novadoz Pharmaceuticals LLC |
PHENYLEPHRINE HYDROCHLORIDE |
D00511
|
|
Dexamethasone tablet 2 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc. |
Dexamethasone |
D00292
|
|
Phentermine Hydrochloride capsule 37.5 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc. |
Phentermine Hydrochloride |
D05459
|
|
desmopressin acetate injection, solution 4 ug/mL (ANDA)
|
Sagent Pharmaceuticals |
desmopressin acetate |
D02235
|
|
desmopressin acetate injection, solution 40 ug0mL (ANDA)
|
Sagent Pharmaceuticals |
desmopressin acetate |
D02235
|
|
GLEOLAN powder, for solution 1500 mg (NDA)
|
Medexus Pharma, Inc. |
AMINOLEVULINIC ACID HYDROCHLORIDE |
D02908
|
|
VALPROIC ACID solution 250 mg/5mL (ANDA)
|
QUAGEN PHARMACEUTICALS LLC |
VALPROIC ACID |
D00399
|
|
Abacavir tablet, film coated 300 mg (ANDA)
|
Aurobindo Pharma Limited |
Abacavir |
D00891
|
|
CAMILA tablet .35 mg (ANDA)
|
Dr. Reddy's Labratories Inc. |
NORETHINDRONE |
D00182
|
Cefprozil tablet, film coated 250 mg (ANDA)
Cefprozil tablet, film coated 500 mg (ANDA)
|
NorthStar Rx LLC |
Cefprozil |
D00261
|
Diazepam tablet 2 mg (ANDA)
Diazepam tablet 5 mg (ANDA)
Diazepam tablet 10 mg (ANDA)
|
Chartwell RX, LLC |
Diazepam |
D00293
|
|
Sensorcaine MPF injection, solution 5 mg/mL (ANDA)
|
Henry Schein, Inc. |
bupivacaine hydrochloride |
D01450
|
Levetiracetam solution 100 mg/mL (ANDA)
Levetiracetam solution 1000 mg0mL (ANDA)
Levetiracetam solution 1500 mg5mL (ANDA)
Levetiracetam solution 500 mg/5mL (ANDA)
|
PAI Holdings, LLC dba PAI Pharma |
LEVETIRACETAM |
D00709
|
|
Balsalazide Disodium capsule 750 mg (ANDA)
|
Hikma Pharmaceuticals USA Inc. |
Balsalazide Disodium |
D02715
|
haloperidol decanoate injection, solution 50 mg/mL (ANDA)
haloperidol decanoate injection, solution 100 mg/mL (ANDA)
haloperidol decanoate injection, solution 500 mg/5mL (ANDA)
|
Sagent Pharmaceuticals |
haloperidol decanoate |
D01898
|
Cefprozil tablet, film coated 250 mg (ANDA)
Cefprozil tablet, film coated 500 mg (ANDA)
|
Aurobindo Pharma Limited |
Cefprozil |
D00261
|
|
Finasteride tablet, film coated 1 mg (ANDA)
|
Burel Pharmaceuticals, LLC |
Finasteride |
D00321
|
|
NICARDIPINE HYDROCHLORIDE injection, solution 25 mg0mL (ANDA)
|
Eugia US LLC |
NICARDIPINE HYDROCHLORIDE |
D00617
|
pitavastatin calcium tablet, film coated 1.045 mg (ANDA)
pitavastatin calcium tablet, film coated 2.09 mg (ANDA)
pitavastatin calcium tablet, film coated 4.18 mg (ANDA)
|
Camber Pharmaceuticals, Inc. |
pitavastatin calcium |
D01862
|
Oxycodone Hydrochloride tablet 5 mg (ANDA)
Oxycodone Hydrochloride tablet 10 mg (ANDA)
Oxycodone Hydrochloride tablet 15 mg (ANDA)
Oxycodone Hydrochloride tablet 20 mg (ANDA)
Oxycodone Hydrochloride tablet 30 mg (ANDA)
|
Amneal Pharmaceuticals LLC |
Oxycodone |
D00847
|
|
ESTRADIOL gel 1 mg/g (ANDA)
|
Bryant Ranch Prepack |
estradiol |
D00105
|
|
TADALAFIL tablet 10 mg (ANDA)
|
NuCare Pharmaceuticals,Inc. |
tadalafil |
D02008
|
|
Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate capsule 325 mg (ANDA)
|
LGM PHARMA SOLUTIONS, LLC |
Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate |
D11851
|
|
desoximetasone spray 2.5 mg/mL (ANDA)
|
Bryant Ranch Prepack |
desoximetasone |
D03697
|