| Product |
Company |
Generic name |
KEGG DRUG |
|
Solucion InterSol solution 452 mg00mL (NDA)
|
Fenwal, Inc. |
Solucion aditiva para plaquetas 3 |
|
|
CANDESARTAN CILEXETIL tablet 32 mg (ANDA)
|
Alembic Pharmaceuticals Inc. |
CANDESARTAN CILEXETIL |
D00626
|
|
Lorazepam tablet 2 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC |
Lorazepam |
D00365
|
|
CISplatin injection, solution 1 mg/mL (NDA)
|
WG Critical Care, LLC |
CISplatin |
D00275
|
Meprobamate tablet 200 mg (ANDA)
Meprobamate tablet 400 mg (ANDA)
|
Alembic Pharmaceuticals Inc. |
Meprobamate |
D00376
|
|
Heparin Sodium injection, solution 5000 [USP'U]/mL (NDA)
|
Fresenius Kabi USA, LLC |
HEPARIN SODIUM |
D02112
|
Modafinil tablet 100 mg (ANDA)
Modafinil tablet 200 mg (ANDA)
|
Alembic Pharmaceuticals Inc. |
Modafinil |
D01832
|
|
Ursodiol capsule 300 mg (ANDA)
|
PuraCap Laboratories, LLC |
Ursodiol |
D00734
|
CANDESARTAN CILEXETIL tablet 4 mg (ANDA)
CANDESARTAN CILEXETIL tablet 8 mg (ANDA)
CANDESARTAN CILEXETIL tablet 16 mg (ANDA)
|
Alembic Pharmaceuticals Inc. |
CANDESARTAN CILEXETIL |
D00626
|
DROXIDOPA capsule 100 mg (ANDA)
DROXIDOPA capsule 200 mg (ANDA)
DROXIDOPA capsule 300 mg (ANDA)
|
Bionpharma Inc. |
DROXIDOPA |
D01277
|
|
Buspirone Hydrochloride tablet 10 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC |
Buspirone Hydrochloride |
D00702
|
|
Dutasteride capsule, liquid filled .5 mg (ANDA)
|
XLCare Pharmaceuticals, Inc. |
Dutasteride |
D03820
|
|
Dutasteride capsule, liquid filled .5 mg (ANDA)
|
Camber Pharmaceuticals, Inc. |
Dutasteride |
D03820
|
|
Metaxalone tablet 800 mg (ANDA)
|
Doc Rx |
Metaxalone |
D00773
|
|
Etodolac tablet, film coated 400 mg (ANDA)
|
Doc Rx |
Etodolac |
D00315
|
Fenofibrate capsule 67 mg (ANDA)
Fenofibrate capsule 134 mg (ANDA)
Fenofibrate capsule 200 mg (ANDA)
|
Aurobindo Pharma Limited |
Fenofibrate |
D00565
|
Atorvastatin Calcium tablet 10 mg (ANDA)
Atorvastatin Calcium tablet 20 mg (ANDA)
Atorvastatin Calcium tablet 40 mg (ANDA)
|
Dr. Reddy's Laboratories Limited |
Atorvastatin Calcium |
D02258
|
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)
|
Florida Pharmaceutical Products, LLC |
Doxepin Hydrochloride |
D00814
|
Baclofen tablet 10 mg (ANDA)
Baclofen tablet 20 mg (ANDA)
Baclofen tablet 5 mg (ANDA)
|
Lannett Company, Inc. |
baclofen |
D00241
|
PHENYLEPHRINE HYDROCHLORIDE injection 10 mg/mL (ANDA)
PHENYLEPHRINE HYDROCHLORIDE injection 50 mg/5mL (ANDA)
PHENYLEPHRINE HYDROCHLORIDE injection 100 mg0mL (ANDA)
|
Somerset Therapeutics, LLC |
PHENYLEPHRINE HYDROCHLORIDE |
D00511
|
|
Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate tablet, film coated 600 mg (ANDA)
|
Macleods Pharmaceuticals Limited |
Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate |
D10851
|
|
Incassia tablet .35 mg (ANDA)
|
Aurobindo Pharma Limited |
NORETHINDRONE |
D00182
|
|
decitabine injection, powder, lyophilized, for solution 50 mg0mL (ANDA)
|
Gland Pharma Limited |
decitabine |
D03665
|
|
Diazepam solution 5 mg/5mL (ANDA)
|
Pharmaceutical Associates, Inc. |
Diazepam |
D00293
|
Valsartan tablet, film coated 40 mg (ANDA)
Valsartan tablet, film coated 80 mg (ANDA)
Valsartan tablet, film coated 160 mg (ANDA)
Valsartan tablet, film coated 320 mg (ANDA)
|
Unichem Pharmaceuticals (USA), Inc. |
Valsartan |
D00400
|
|
Verapamil Hydrochloride injection 2.5 mg/mL (NDA)
|
EXELA PHARMA SCIENCES, LLC |
Verapamil Hydrochloride |
D00619
|
|
Demser capsule 250 mg (NDA)
|
Bausch Health US, LLC |
metyrosine |
D00762
|
|
Metyrosine capsule 250 mg (NDA AUTHORIZED GENERIC)
|
Oceanside Pharmaceuticals |
Metyrosine |
D00762
|
|
Amoxicillin powder, for suspension 400 mg/5mL (ANDA)
|
Proficient Rx LP |
Amoxicillin |
D00229
|
Fondaparinux Sodium injection 2.5 mg/.5mL (ANDA)
Fondaparinux Sodium injection 5 mg/.4mL (ANDA)
Fondaparinux Sodium injection 7.5 mg/.6mL (ANDA)
Fondaparinux Sodium injection 10 mg/.8mL (ANDA)
|
Dr. Reddy's Laboratories Limited |
Fondaparinux Sodium |
D01844
|
METHYLPHENIDATE HYDROCHLORIDE tablet 5 mg (ANDA)
METHYLPHENIDATE HYDROCHLORIDE tablet 10 mg (ANDA)
METHYLPHENIDATE HYDROCHLORIDE tablet 20 mg (ANDA)
|
XLCare Pharmaceuticals Inc |
METHYLPHENIDATE HYDROCHLORIDE |
D01296
|
Methylphenidate Hydrochloride tablet, extended release 18 mg (ANDA)
Methylphenidate Hydrochloride tablet, extended release 27 mg (ANDA)
Methylphenidate Hydrochloride tablet, extended release 36 mg (ANDA)
Methylphenidate Hydrochloride tablet, extended release 54 mg (ANDA)
|
XLCare Pharmaceuticals, Inc. |
Methylphenidate Hydrochloride |
D01296
|
Methylphenidate Hydrochloride tablet, extended release 18 mg (ANDA)
Methylphenidate Hydrochloride tablet, extended release 27 mg (ANDA)
Methylphenidate Hydrochloride tablet, extended release 36 mg (ANDA)
Methylphenidate Hydrochloride tablet, extended release 54 mg (ANDA)
|
Camber Pharmaceuticals, Inc. |
Methylphenidate Hydrochloride |
D01296
|
|
Norepinephrine Bitartrate solution 1 mg/mL (ANDA)
|
Fresenius Kabi USA, LLC |
NOREPINEPHRINE BITARTRATE |
D05206
|
|
Ketoconazole cream 20 mg/g (ANDA)
|
Teva Pharmaceuticals USA, Inc. |
Ketoconazole |
D00351
|
Ranolazine tablet, film coated, extended release 500 mg (ANDA)
Ranolazine tablet, film coated, extended release 1000 mg (ANDA)
|
Westminster Pharmaceuticals, LLC |
Ranolazine |
D05700
|
|
Nystatin and triamcinolone acetonide ointment 100000 [USP'U]/g (ANDA)
|
Macleods Pharmaceuticals Limited |
Nystatin and triamcinolone acetonide |
D10299
|
Asenapine tablet 10 mg (ANDA)
Asenapine tablet 5 mg (ANDA)
Asenapine tablet 2.5 mg (ANDA)
|
MSN LABORATORIES PRIVATE LIMITED |
ASENAPINE MALEATE |
D02995
|
|
Oxycodone and Acetaminophen tablet 5 mg (ANDA)
|
Asclemed USA, Inc. |
Oxycodone and Acetaminophen |
D02153
|
Xylocaine injection, solution 5 mg/mL (NDA)
Xylocaine injection, solution 10 mg/mL (NDA)
Xylocaine injection, solution 20 mg/mL (NDA)
Xylocaine MPF injection, solution 10 mg/mL (NDA)
Xylocaine MPF injection, solution 15 mg/mL (NDA)
Xylocaine MPF injection, solution 20 mg/mL (NDA)
Xylocaine MPF injection, solution 5 mg/mL (NDA)
|
Fresenius Kabi USA, LLC |
LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE |
D04813
|