| Product |
Company |
Generic name |
KEGG DRUG |
sirolimus tablet, film coated .5 mg (ANDA)
sirolimus tablet, film coated 1 mg (ANDA)
sirolimus tablet, film coated 2 mg (ANDA)
|
Glenmark Pharmaceuticals Inc., USA |
sirolimus |
D00753
|
Flecainide Acetate tablet 50 mg (ANDA)
Flecainide Acetate tablet 100 mg (ANDA)
Flecainide Acetate tablet 150 mg (ANDA)
|
UNICHEM PHARMACEUTICALS (USA), INC. |
flecainide acetate |
D00638
|
|
Fludeoxyglucose F 18 injection, solution 300 mCi/mL (ANDA)
|
Jubilant DraxImage Inc., dba Jubilant Radiopharma |
Fludeoxyglucose F-18 |
D01843
|
|
Clobetasol Propionate cream .5 mg/g (ANDA)
|
Glenmark Pharmaceutcials Inc., USA |
Clobetasol Propionate |
D01272
|
|
doxycycline hyclate capsule 50 mg (ANDA)
|
Bryant Ranch Prepack |
doxycycline hyclate |
D02129
|
Irbesartan and Hydrochlorothiazide tablet, film coated 300 mg (ANDA)
Irbesartan and Hydrochlorothiazide tablet, film coated 150 mg (ANDA)
|
Teva Pharmaceuticals USA, Inc. |
Irbesartan and Hydrochlorothiazide |
D10249
|
|
Brimonidine Tartrate solution/ drops 2 mg/mg (ANDA)
|
Florida Pharmaceutical Products, LLC |
Brimonidine Tartrate |
D02076
|
DROXIA capsule 200 mg (NDA)
DROXIA capsule 300 mg (NDA)
DROXIA capsule 400 mg (NDA)
|
H2-Pharma LLC |
HYDROXYUREA |
D00341
|
|
Doxycycline Hyclate tablet, film coated 100 mg (ANDA)
|
Bryant Ranch Prepack |
Doxycycline Hyclate |
D02129
|
|
Glyburide tablet 5 mg (ANDA)
|
Preferred Pharmaceuticals Inc. |
Glyburide |
D00336
|
Telmisartan tablet 20 mg (ANDA)
Telmisartan tablet 40 mg (ANDA)
Telmisartan tablet 80 mg (ANDA)
|
Glenmark Pharmaceuticals Inc., USA |
Telmisartan |
D00627
|
|
Clindamycin Phosphate gel 10 mg/g (ANDA)
|
GLENMARK PHARMACEUTICALS INC., USA |
Clindamycin Phosphate |
D01073
|
|
Escitalopram tablet, film coated 5 mg (ANDA)
|
Northwind Health Company, LLC |
Escitalopram |
D02567
|
|
METFORMIN HYDROCHLORIDE tablet 500 mg (ANDA)
|
Preferred Pharmaceuticals Inc |
METFORMIN HYDROCHLORIDE |
D00944
|
|
Buspirone Hydrochloride tablet 10 mg (ANDA)
|
A-S Medication Solutions |
Buspirone Hydrochloride |
D00702
|
|
Ondansetron Hydrochloride tablet, film coated 8 mg (ANDA)
|
Northwind Health Company, LLC |
Ondansetron Hydrochloride |
D00678
|
|
MELOXICAM tablet 7.5 mg (ANDA)
|
Northwind Health Company, LLC |
meloxicam |
D00969
|
|
Metformin Hydrochloride tablet, film coated 500 mg (ANDA)
|
A-S Medication Solutions |
Metformin Hydrochloride |
D00944
|
|
Sulfamethoxazole and Trimethoprim tablet 800 mg (ANDA)
|
Northwind Health Company, LLC |
Sulfamethoxazole and Trimethoprim |
D00285
|
|
Gentamicin injection, solution 10 mg/mL (ANDA)
|
Eugia US LLC |
Gentamicin |
D01063
|
|
Aripiprazole tablet 5 mg (ANDA)
|
Bryant Ranch Prepack |
Aripiprazole |
D01164
|
|
METHYLENE BLUE injection 50 mg0mL (ANDA)
|
Chengdu Shuode Pharmaceutical Co., Ltd |
METHYLENE BLUE |
D02312
|
|
Promethazine Hydrochloride tablet 25 mg (ANDA)
|
Northwind Health Company, LLC |
Promethazine Hydrochloride |
D00480
|
|
DORZOLAMIDE HYDROCHLORIDE TIMOLOL MALETAE solution/ drops 20 mg/mL (ANDA)
|
Indoco Remedies Limited |
ddorzolamide hydrochloride timolol maleate |
D08493
|
|
Medroxyprogesterone Acetate tablet 10 mg (ANDA)
|
Northwind Health Company, LLC |
Medroxyprogesterone Acetate |
D00951
|
|
Prednisone tablet 10 mg (ANDA)
|
Northwind Health Company, LLC |
Prednisone |
D00473
|
|
Lorazepam tablet .5 mg (ANDA)
|
REMEDYREPACK INC. |
Lorazepam |
D00365
|
|
RISPERIDONE tablet 4 mg (ANDA)
|
REMEDYREPACK INC. |
RISPERIDONE |
D00426
|
Nortrel 21 Day tablet 1 mg (ANDA)
Nortrel 28 Day kit (ANDA)
|
Teva Pharmaceuticals USA, Inc. |
Norethindrone and Ethinyl Estradiol |
D04483
|
|
Gavreto capsule 100 mg (NDA)
|
Rigel Pharmaceuticals, Inc. |
Pralsetinib |
D11712
|
|
Dexmedetomidine Hydrochloride injection, solution 100 ug/mL (ANDA)
|
Fresenius Kabi USA, LLC |
dexmedetomidine hydrochloride |
D01205
|
CYCLOBENZAPRINE HYDROCHLORIDE tablet, film coated 5 mg (ANDA)
CYCLOBENZAPRINE HYDROCHLORIDE tablet, film coated 10 mg (ANDA)
|
Medcore LLC |
cyclobenzaprine hydrochloride |
D00772
|
|
Polymyxin B Sulfate and Trimethoprim solution 10000 [USP'U]/mL (ANDA)
|
REMEDYREPACK INC. |
Polymyxin B Sulfate and Trimethoprim |
D11086
|
sevelamer hydrochloride tablet, film coated 400 mg (ANDA)
sevelamer hydrochloride tablet, film coated 800 mg (ANDA)
|
Glenmark Pharmaceuticals Inc., USA |
sevelamer hydrochloride |
D01983
|
|
BYQLOVI for suspension .5 mg/mL (NDA)
|
Harrow Eye, LLC |
clobetasol propionate |
D01272
|
Mycophenolate mofetil tablet, film coated 500 mg (ANDA)
Mycophenolate mofetil capsule 250 mg (ANDA)
|
Strides Pharma Science Limited |
Mycophenolate mofetil |
D00752
|
Carvedilol tablet, film coated 3.125 mg (ANDA)
Carvedilol tablet, film coated 6.25 mg (ANDA)
Carvedilol tablet, film coated 12.5 mg (ANDA)
Carvedilol tablet, film coated 25 mg (ANDA)
|
UNICHEM PHARMACEUTICALS (USA), INC. |
Carvedilol |
D00255
|
Adalimumab injection, solution 40 mg/.4mL (BLA)
Adalimumab injection, solution 80 mg/.8mL (BLA)
Adalimumab injection, solution 20 mg/.2mL (BLA)
Adalimumab injection, solution 10 mg/.1mL (BLA)
|
Sandoz Inc |
adalimumab-adaz |
D02597
|
|
Dicyclomine hydrochloride tablet 20 mg (ANDA)
|
REMEDYREPACK INC. |
Dicyclomine hydrochloride |
D00717
|
Vasotec tablet 2.5 mg (NDA)
Vasotec tablet 5 mg (NDA)
Vasotec tablet 10 mg (NDA)
Vasotec tablet 20 mg (NDA)
|
Bausch Health US LLC |
Enalapril Maleate |
D00621
|