| Product |
Company |
Generic name |
KEGG DRUG |
|
bivalirudin injection, powder, lyophilized, for suspension 250 mg (ANDA)
|
Slate Run Pharmaceuticals, LLC |
bivalirudin |
D11280
|
Metformin Hydrochloride tablet, film coated, extended release 500 mg (ANDA)
Metformin Hydrochloride tablet, film coated, extended release 1000 mg (ANDA)
|
ScieGen Pharmaceuticals, Inc. |
Metformin Hydrochloride Extended-Release Tablets |
D00944
|
|
FUROSEMIDE injection, solution 10 mg/mL (NDA)
|
HF Acquisition Co LLC, DBA HealthFirst |
FUROSEMIDE |
D00331
|
|
FLUMAZENIL injection, solution .1 mg/mL (ANDA)
|
HF Acquisition Co LLC, DBA HealthFirst |
FLUMAZENIL |
D00697
|
|
(SOTRADECOL) SODIUM TETRADECYL SULFATE injection, solution 30 mg/mL (ANDA)
|
HF Acquisition Co LLC, DBA HealthFirst |
(SOTRADECOL) SODIUM TETRADECYL SULFATE |
D06882
|
Cyclobenzaprine Hydrochloride tablet, film coated 5 mg (ANDA)
Cyclobenzaprine Hydrochloride tablet, film coated 10 mg (ANDA)
|
Rising Pharma Holdings, Inc. |
Cyclobenzaprine Hydrochloride |
D00772
|
Budesonide suspension .25 mg/2mL (ANDA)
Budesonide suspension .5 mg/2mL (ANDA)
|
Teva Pharmaceuticals USA, Inc. |
Budesonide |
D00246
|
|
lithium carbonate capsule 300 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC |
lithium carbonate |
D00801
|
Budesonide suspension .25 mg/2mL (ANDA)
Budesonide suspension .5 mg/2mL (ANDA)
|
Teva Pharmaceuticals USA, Inc. |
Budesonide |
D00246
|
zaleplon capsule 5 mg (ANDA)
zaleplon capsule 10 mg (ANDA)
|
Unichem Pharmaceuticals (USA), Inc. |
zaleplon |
D00530
|
Bleomycin powder, for solution 15 [USP'U] (ANDA)
Bleomycin powder, for solution 30 [USP'U] (ANDA)
|
Meitheal Pharmaceuticals Inc. |
Bleomycin Sulfate |
D02177
|
|
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
|
|
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
|
|
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
|
|
Triamcinolone Acetonide ointment .5 mg/g (ANDA)
|
Strides Pharma Science Limited |
Triamcinolone Acetonide |
D00983
|
Metoprolol Succinate tablet, extended release 25 mg (ANDA)
Metoprolol Succinate tablet, extended release 100 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC |
Metoprolol Succinate |
D00635
|
|
Foscarnet injection, solution 24 mg/mL (ANDA)
|
Fresenius Kabi USA, LLC |
foscarnet sodium |
D02267
|
|
Gemfibrozil tablet 600 mg (ANDA)
|
Cipla USA Inc. |
Gemfibrozil |
D00334
|
|
Gemfibrozil tablet, film coated 600 mg (ANDA)
|
Exelan Pharmaceuticals, Inc. |
Gemfibrozil |
D00334
|
|
Tranylcypromine tablet 10 mg (ANDA)
|
Novitium Pharma LLC |
Tranylcypromine |
D00826
|
Meprobamate tablet 200 mg (ANDA)
Meprobamate tablet 400 mg (ANDA)
|
Cipla USA Inc. |
Meprobamate |
D00376
|
|
Metformin Hydrochloride tablet 1000 mg (ANDA)
|
St. Mary's Medical Park Pharmacy |
Metformin Hydrochloride |
D00944
|
|
CPDA-1 solution 19.3 mg/70mL (NDA)
|
Fenwal, Inc. |
Anticoagulant Citrate Phosphate Dextrose Adenine |
D02954
|
montelukast sodium tablet, chewable 4 mg (ANDA)
montelukast sodium tablet, chewable 5 mg (ANDA)
|
Camber Pharmaceuticals, Inc. |
montelukast sodium |
D00529
|
|
CPDA-1 solution 19.3 mg/70mL (NDA)
|
Fenwal, Inc. |
Anticoagulant Citrate Phosphate Dextrose Adenine |
D02954
|
|
PAROXETINE capsule 7.5 mg (ANDA)
|
Solco Healthcare LLC |
paroxetine |
D05375
|
|
CPDA-1 solution 17.3 mg/63mL (NDA)
|
Fenwal, Inc. |
Anticoagulant Citrate Phosphate Dextrose Adenine |
D02954
|
candesartan cilexetil and hydrochlorothiazide tablet 16 mg (ANDA)
candesartan cilexetil and hydrochlorothiazide tablet 32 mg (ANDA)
|
Solco Healthcare LLC |
candesartan cilexetil and hydrochlorothiazide |
D09196
|
|
CPDA-1 solution 19.3 mg/70mL (NDA)
|
Fenwal, Inc. |
Anticoagulant Citrate Phosphate Dextrose Adenine |
D02954
|
OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE tablet 12.5 mg (ANDA)
OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE tablet 25 mg (ANDA)
|
Solco Healthcare US, LLC |
olmesartan medoxomil and hydrochlorothiazide |
D10284
|
|
CPDA-1 solution 19.3 mg/70mL (NDA)
|
Fenwal, Inc. |
Anticoagulant Citrate Phosphate Dextrose Adenine |
D02954
|
Pramipexole Dihydrochloride Extended-Release tablet, extended release .375 mg (ANDA)
Pramipexole Dihydrochloride Extended-Release tablet, extended release .75 mg (ANDA)
|
Xiamen LP Pharmaceutical Co., Ltd. |
Pramipexole Dihydrochloride |
D00559
|
|
CPDA-1 solution 19.3 mg/70mL (NDA)
|
Fenwal, Inc. |
Anticoagulant Citrate Phosphate Dextrose Adenine |
D02954
|
Mitomycin injection, powder, lyophilized, for solution 5 mg0mL (ANDA)
Mitomycin injection, powder, lyophilized, for solution 20 mg/40mL (ANDA)
Mitomycin injection, powder, lyophilized, for solution 40 mg/80mL (ANDA)
|
BluePoint Laboratories |
Mitomycin |
D00208
|
Thalitone tablet 25 mg (NDA)
Thalitone tablet 15 mg (NDA)
|
Casper Pharma LLC |
chlorthalidone |
D00272
|
|
CPDA-1 solution 17.3 mg/63mL (NDA)
|
Fenwal, Inc. |
Anticoagulant Citrate Phosphate Dextrose Adenine |
D02954
|
|
Cefuroxime Axetil tablet 250 mg (ANDA)
|
A-S Medication Solutions |
Cefuroxime Axetil |
D00914
|
|
Thiamine Hydrochloride injection, solution 100 mg/mL (ANDA)
|
Mylan Institutional LLC |
thiamine hydrochloride |
D02094
|
|
Busulfan injection, solution 6 mg/mL (ANDA)
|
Meitheal Pharmaceuticals Inc. |
Busulfan |
D00248
|
|
Loteprednol Etabonate gel 5 mg/g (NDA AUTHORIZED GENERIC)
|
Bausch & Lomb Incorporated |
loteprednol etabonate |
D01689
|