| Product |
Company |
Generic name |
KEGG DRUG |
|
betamethasone dipropionate ointment .5 mg/g (ANDA)
|
Zydus Lifesciences Limited |
betamethasone dipropionate |
D01637
|
|
Sodium Citrate Blood-Pack Units, (PL 146 Plastic) solution 4 g00mL (NDA)
|
Fenwal, Inc. |
Anticoagulant Sodium Citrate Solution |
D02957
|
|
Arsenic trioxide injection, solution 1 mg/mL (ANDA)
|
Zydus Lifesciences Limited |
Arsenic trioxide |
D02106
|
|
Arsenic trioxide injection, solution 2 mg/mL (ANDA)
|
Zydus Lifesciences Limited |
Arsenic trioxide |
D02106
|
Doxycycline injection, powder, lyophilized, for solution 100 mg0mL (ANDA)
Doxycycline injection, powder, lyophilized, for solution 200 mg/20mL (ANDA)
|
Zydus Lifesciences Limited |
Doxycycline |
D02129
|
|
Verapamil Hydrochloride injection, solution 2.5 mg/mL (ANDA)
|
Zydus Lifesciences Limited |
Verapamil Hydrochloride |
D00619
|
cisatracurium besylate injection 2 mg/mL (ANDA)
cisatracurium besylate injection 10 mg/mL (ANDA)
|
Zydus Lifesciences Limited |
cisatracurium besylate |
D00759
|
|
DOXORUBICIN HYDROCHLORIDE injectable, liposomal 2 mg/mL (ANDA)
|
Zydus Lifesciences Limited |
doxorubicin hydrochloride |
D01275
|
|
Phytonadione tablet 5 mg (ANDA)
|
Zydus Lifesciences Limited |
Phytonadione |
D00148
|
AMITRIPTYLINE HYDROCHLORIDE tablet, film coated 10 mg (ANDA)
AMITRIPTYLINE HYDROCHLORIDE tablet, film coated 100 mg (ANDA)
AMITRIPTYLINE HYDROCHLORIDE tablet, film coated 150 mg (ANDA)
|
Accord Healthcare Inc. |
AMITRIPTYLINE HYDROCHLORIDE |
D00809
|
MEMANTINE HYDROCHLORIDE capsule, extended release 7 mg (ANDA)
MEMANTINE HYDROCHLORIDE capsule, extended release 14 mg (ANDA)
MEMANTINE HYDROCHLORIDE capsule, extended release 21 mg (ANDA)
MEMANTINE HYDROCHLORIDE capsule, extended release 28 mg (ANDA)
MEMANTINE HYDROCHLORIDE kit (ANDA)
|
Aurobindo Pharma Limited |
MEMANTINE HYDROCHLORIDE |
D04905
|
|
Carbidopa tablet 25 mg (ANDA)
|
NorthStar Rx LLC |
Carbidopa |
D00558
|
|
Isotretinoin capsule, liquid filled 40 mg (ANDA)
|
Mayne Pharma |
Isotretinoin |
D00348
|
Chlorthalidone tablet 25 mg (ANDA)
Chlorthalidone tablet 50 mg (ANDA)
|
Sun Pharmaceutical Industries, Inc. |
Chlorthalidone |
D00272
|
Promethazine Hydrochloride suppository 12.5 mg (ANDA)
Promethazine Hydrochloride suppository 25 mg (ANDA)
|
Camber Pharmaceuticals, Inc. |
Promethazine Hydrochloride |
D00480
|
Isotretinoin capsule, liquid filled 10 mg (ANDA)
Isotretinoin capsule, liquid filled 20 mg (ANDA)
Isotretinoin capsule, liquid filled 30 mg (ANDA)
|
Mayne Pharma |
Isotretinoin |
D00348
|
|
Hydroxyzine Pamoate capsule 25 mg (ANDA)
|
Proficient Rx LP |
Hydroxyzine Pamoate |
D01096
|
Pemetrexed disodium injection, powder, lyophilized, for solution 1 g/40mL (ANDA)
Pemetrexed disodium injection, powder, lyophilized, for solution 100 mg/4mL (ANDA)
Pemetrexed disodium injection, powder, lyophilized, for solution 500 mg/20mL (ANDA)
|
Dr. Reddys Laboratories Inc |
Pemetrexed disodium |
D03828
|
|
Metformin Hydrochloride tablet 1000 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC |
Metformin Hydrochloride |
D00944
|
|
losartan potassium and hydrochlorothiazide tablet, film coated 25 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC |
losartan potassium and hydrochlorothiazide |
D07895
|
|
Clonazepam tablet .5 mg (ANDA)
|
Proficient Rx LP |
clonazepam |
D00280
|
|
Duloxetine capsule, delayed release 20 mg (ANDA)
|
Proficient Rx LP |
Duloxetine |
D01179
|
|
Hydroxyzine Hydrochloride tablet, film coated 50 mg (ANDA)
|
Proficient Rx LP |
Hydroxyzine Hydrochloride |
D00672
|
Valsartan and Hydrochlorothiazide tablet, film coated 12.5 mg (ANDA)
Valsartan and Hydrochlorothiazide tablet 25 mg (ANDA)
Valsartan and Hydrochlorothiazide tablet, film coated 25 mg (ANDA)
|
Macleods Pharmaceuticals Limited |
Valsartan and Hydrochlorothiazide |
D09197
|
|
Trimethoprim tablet 100 mg (ANDA)
|
Novitium Pharma LLC |
Trimethoprim |
D00145
|
|
ADSOL RED CELL PRESERVATION kit (NDA)
|
Fenwal, Inc. |
anticoagulant citrate phosphate dextrose (cpd) and adsol preservation |
D08745
|
|
Ceftriaxone Sodium injection, powder, for solution 2 g (ANDA)
|
Proficient Rx LP |
Ceftriaxone Sodium |
D00924
|
|
Rosuvastatin calcium tablet, film coated 20 mg (ANDA)
|
Proficient Rx LP |
Rosuvastatin calcium |
D01915
|
|
Labetalol hydrochloride tablet, film coated 100 mg (ANDA)
|
Proficient Rx LP |
Labetalol hydrochloride |
D00600
|
|
ADSOL RED CELL PRESERVATION kit (NDA)
|
Fenwal, Inc. |
anticoagulant citrate phosphate dextrose (cpd) and adsol preservation |
D08745
|
Cyanocobalamin injection 1000 ug/mL (ANDA)
cyanocobalamin injection 1000 ug/mL (ANDA)
|
Gland Pharma Limited |
Cyanocobalamin |
D00166
|
|
METFORMIN HYDROCHLORIDE tablet 1000 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC |
METFORMIN HYDROCHLORIDE |
D00944
|
|
Rosuvastatin calcium tablet, film coated 10 mg (ANDA)
|
Proficient Rx LP |
Rosuvastatin Calcium |
D01915
|
Piperacillin and Tazobactam injection, powder, lyophilized, for solution 2 g0mL (ANDA)
Piperacillin and Tazobactam injection, powder, lyophilized, for solution 4 g/20mL (ANDA)
Piperacillin and Tazobactam injection, powder, lyophilized, for solution 3 g5mL (ANDA)
|
Fresenius Kabi USA, LLC |
Piperacillin and Tazobactam |
D02505
|
Lamotrigine tablet, orally disintegrating 25 mg (ANDA)
Lamotrigine tablet, orally disintegrating 50 mg (ANDA)
Lamotrigine tablet, orally disintegrating 100 mg (ANDA)
Lamotrigine tablet, orally disintegrating 200 mg (ANDA)
|
ScieGen Pharmaceuticals, Inc. |
Lamotrigine |
D00354
|
|
KETOROLAC TROMETHAMINE tablet 10 mg (ANDA)
|
ATNAHS PHARMA US LIMITED |
KETOROLAC TROMETHAMINE |
D00813
|
|
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
|
|
Acetylcysteine injection, solution 200 mg/mL (ANDA)
|
Fresenius Kabi USA, LLC |
Acetylcysteine |
D00221
|
|
Acetylcysteine solution 200 mg/mL (ANDA)
|
Fresenius Kabi USA, LLC |
ACETYLCYSTEINE |
D00221
|
Imipenem and Cilastatin injection, powder, for solution 500 mg/20mL (ANDA)
Imipenem and Cilastatin injection, powder, for solution 250 mg/20mL (ANDA)
|
Fresenius Kabi USA, LLC |
Imipenem and Cilastatin Sodium |
D00344
|