| Product |
Company |
Generic name |
KEGG DRUG |
|
PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride powder, for solution 420 g/4L (NDA AUTHORIZED GENERIC)
|
Affordable Pharmaceuticals, LLC |
polyethylene glycol 3350, sodium chloride, sodium bicarbonate, potassium chloride |
|
|
ADSOL Red Cell Preservation Solution System in Plastic Container (PL 146 Plastic) kit (NDA)
|
Fenwal, Inc. |
Anticoagulant Citrate Phosphate Dextrose (CPD) Solution and ADSOL Preservation Solution |
D08745
|
|
SOLTAMOX liquid 20 mg0mL (NDA)
|
Mayne Pharma |
TAMOXIFEN CITRATE |
D00966
|
|
Triamcinolone Acetonide cream 1 mg/g (ANDA)
|
Asclemed USA, Inc. |
Triamcinolone Acetonide |
D00983
|
|
PREDNISOLONE ACETATE suspension/ drops 10 mg/mL (NDA AUTHORIZED GENERIC)
|
Asclemed USA, Inc. |
prednisolone acetate |
D00980
|
|
doxycycline capsule 100 mg (ANDA)
|
Cranbury Pharmaceuticals, LLC |
doxycycline |
D02129
|
|
Erythromycin ointment 5 mg/g (ANDA)
|
Asclemed USA, Inc. |
Erythromycin |
D00140
|
|
Pyrimethamine tablet 25 mg (NDA AUTHORIZED GENERIC)
|
OAKRUM PHARMA, LLC |
pyrimethamine |
D00488
|
Tadalafil tablet, film coated 20 mg (ANDA)
Tadalafil tablet, film coated 10 mg (ANDA)
Tadalafil tablet, film coated 5 mg (ANDA)
Tadalafil tablet, film coated 2.5 mg (ANDA)
|
Dr.Reddys Laboratories Inc |
Tadalafil |
D02008
|
Ondansetron tablet, film coated 4 mg (ANDA)
Ondansetron tablet, film coated 8 mg (ANDA)
|
Natco Pharma Limited |
Ondansetron Tablets |
D00678
|
|
ADSOL Red Cell Preservation Solution System in Plastic Container (PL 146 Plastic) kit (NDA)
|
Fenwal, Inc. |
Anticoagulant Citrate Phosphate Dextrose (CPD) Solution and ADSOL Preservation Solution |
D08745
|
Tetrabenazine tablet 12.5 mg (ANDA)
Tetrabenazine tablet 25 mg (ANDA)
|
Dr. Reddys Laboratories Inc |
Tetrabenazine |
D08575
|
Sotradecol injection, solution 10 mg/mL (ANDA)
Sotradecol injection, solution 30 mg/mL (ANDA)
|
Mylan Institutional LLC |
tetradecyl hydrogen sulfate (ester) |
D06882
|
VANCOMYCIN HYDROCHLORIDE injection, powder, lyophilized, for solution 5 g (ANDA)
VANCOMYCIN HYDROCHLORIDE injection, powder, lyophilized, for solution 10 g (ANDA)
|
Slate Run Pharmaceuticals, LLC |
VANCOMYCIN HYDROCHLORIDE |
D00926
|
|
Amoxicillin capsule 500 mg (ANDA)
|
Asclemed USA, Inc. |
Amoxicillin |
D00229
|
Clomipramine hydrochloride capsule 25 mg (ANDA)
Clomipramine hydrochloride capsule 50 mg (ANDA)
Clomipramine hydrochloride capsule 75 mg (ANDA)
|
Ajanta Pharma USA Inc. |
Clomipramine hydrochloride |
D00811
|
Doxepin hydrochloride capsule 10 mg (ANDA)
Doxepin hydrochloride capsule 25 mg (ANDA)
Doxepin hydrochloride capsule 50 mg (ANDA)
Doxepin hydrochloride capsule 75 mg (ANDA)
Doxepin hydrochloride capsule 100 mg (ANDA)
|
Ajanta Pharma USA Inc. |
Doxepin hydrochloride |
D00814
|
|
Fludeoxyglucose F 18 injection, solution 300 mCi/mL (ANDA)
|
Massachusetts General Hospital |
Fludeoxyglucose F-18 |
D01843
|
|
Ammonia N 13 injection, solution 37.5 mCi/mL (ANDA)
|
Massachusetts General Hospital |
ammonia n-13 |
D02915
|
Tolterodine tartrate capsule, extended release 2 mg (ANDA)
Tolterodine tartrate capsule, extended release 4 mg (ANDA)
|
Ajanta Pharma USA Inc. |
Tolterodine tartrate |
D01148
|
Tetrabenazine tablet 12.5 mg (ANDA)
Tetrabenazine tablet 25 mg (ANDA)
|
Ajanta Pharma USA Inc. |
Tetrabenazine |
D08575
|
CYCLOBENZAPRINE HYDROCHLORIDE tablet, film coated 5 mg (ANDA)
CYCLOBENZAPRINE HYDROCHLORIDE tablet, film coated 10 mg (ANDA)
CYCLOBENZAPRINE HYDROCHLORIDE tablet, film coated 7.5 mg (ANDA)
|
Alembic Pharmaceuticals Inc. |
CYCLOBENZAPRINE HYDROCHLORIDE |
D00772
|
|
Romidepsin kit (ANDA)
|
Fresenius Kabi USA, LLC |
Romidepsin |
D06637
|
Tiagabine Hydrochloride tablet 2 mg (ANDA)
Tiagabine Hydrochloride tablet 4 mg (ANDA)
Tiagabine Hydrochloride tablet 12 mg (ANDA)
Tiagabine Hydrochloride tablet 16 mg (ANDA)
|
Novadoz Pharmaceuticals LLC |
Tiagabine Hydrochloride |
D02097
|
Ranolazine tablet, extended release 500 mg (ANDA)
Ranolazine tablet, extended release 1000 mg (ANDA)
|
Micro Labs Limited |
Ranolazine |
D05700
|
Ranitidine capsule 150 mg (ANDA)
Ranitidine capsule 300 mg (ANDA)
|
Ajanta Pharma USA Inc. |
Ranitidine |
D00673
|
|
Sumatriptan spray 20 mg (ANDA)
|
Florida Pharmaceutical Products, LLC. |
sumatriptan |
D00451
|
MONTELUKAST SODIUM granule 4 mg (ANDA)
MONTELUKAST SODIUM tablet, chewable 4 mg (ANDA)
MONTELUKAST SODIUM tablet, chewable 5 mg (ANDA)
MONTELUKAST SODIUM tablet, coated 10 mg (ANDA)
|
Ajanta Pharma USA Inc. |
MONTELUKAST SODIUM |
D00529
|
|
ACYCLOVIR ointment 50 mg/g (ANDA)
|
Solco Healthcare US, LLC |
acyclovir |
D00222
|
BENZTROPINE MESYLATE tablet .5 mg (ANDA)
BENZTROPINE MESYLATE tablet 1 mg (ANDA)
BENZTROPINE MESYLATE tablet 2 mg (ANDA)
|
Leading Pharma, LLC |
BENZTROPINE MESYLATE |
D00778
|
Famotidine tablet, film coated 20 mg (ANDA)
Famotidine tablet, film coated 40 mg (ANDA)
|
Camber Pharmaceuticals, Inc. |
Famotidine |
D00318
|
|
Thiotepa injection, powder, lyophilized, for solution 15 mg.5mL (ANDA)
|
Hikma Pharmaceuticals USA Inc. |
Thiotepa |
D00583
|
VENLAFAXINE HYDROCHLORIDE tablet, extended release 37.5 mg (ANDA)
VENLAFAXINE HYDROCHLORIDE tablet, extended release 75 mg (ANDA)
VENLAFAXINE HYDROCHLORIDE tablet, extended release 150 mg (ANDA)
VENLAFAXINE HYDROCHLORIDE tablet, extended release 225 mg (ANDA)
|
XLCare Pharmaceuticals, Inc. |
venlafaxine |
D00821
|
VENLAFAXINE HYDROCHLORIDE tablet, extended release 37.5 mg (ANDA)
VENLAFAXINE HYDROCHLORIDE tablet, extended release 75 mg (ANDA)
VENLAFAXINE HYDROCHLORIDE tablet, extended release 150 mg (ANDA)
VENLAFAXINE HYDROCHLORIDE tablet, extended release 225 mg (ANDA)
|
Camber Pharmaceuticals, Inc. |
venlafaxine |
D00821
|
Methylphenidate Hydrochloride (LA) capsule, extended release 20 mg (ANDA)
Methylphenidate Hydrochloride (LA) capsule, extended release 30 mg (ANDA)
Methylphenidate Hydrochloride (LA) capsule, extended release 40 mg (ANDA)
|
Teva Pharmaceuticals USA, Inc. |
Methylphenidate Hydrochloride |
D01296
|
|
Metformin HCl tablet 850 mg (ANDA)
|
Bryant Ranch Prepack |
Metformin HCl |
D00944
|
tadalafil tablet, film coated 2.5 mg (ANDA)
tadalafil tablet, film coated 5 mg (ANDA)
tadalafil tablet, film coated 10 mg (ANDA)
tadalafil tablet, film coated 20 mg (ANDA)
|
VKT Pharma Private Limited |
Tadalafil |
D02008
|
Glucagon injection, powder, lyophilized, for solution 1 mg/mL (NDA)
Glucagon kit (NDA)
|
Fresenius Kabi USA, LLC |
Glucagon |
D02118
|
|
InterSol solution 442 mg00mL (NDA)
|
Fenwal, Inc. |
Platelet Additive 3 |
|
Fenofibrate tablet, film coated 54 mg (ANDA)
Fenofibrate tablet, film coated 160 mg (ANDA)
|
Alembic Pharmaceuticals Inc. |
Fenofibrate |
D00565
|