| Product |
Company |
Generic name |
KEGG DRUG |
PONVORY kit (NDA)
PONVORY tablet, film coated 20 mg (NDA)
|
Vanda Pharmaceuticals Inc. |
Ponesimod |
D11215
|
Hydralazine Hydrochloride tablet, film coated 10 mg (ANDA)
Hydralazine Hydrochloride tablet, film coated 25 mg (ANDA)
Hydralazine Hydrochloride tablet, film coated 50 mg (ANDA)
Hydralazine Hydrochloride tablet, film coated 100 mg (ANDA)
|
Chartwell RX, LLC |
Hydralazine Hydrochloride |
D01302
|
SULINDAC tablet 150 mg (ANDA)
SULINDAC tablet 200 mg (ANDA)
|
PuraCap Laboratories LLC dba Blu Pharmaceuticals |
SULINDAC |
D00120
|
Cardizem CD capsule, coated, extended release 120 mg (NDA)
Cardizem CD capsule, coated, extended release 180 mg (NDA)
Cardizem CD capsule, coated, extended release 240 mg (NDA)
Cardizem CD capsule, coated, extended release 300 mg (NDA)
Cardizem CD capsule, coated, extended release 360 mg (NDA)
|
Bausch Health US LLC |
diltiazem hydrochloride |
D00616
|
|
Cephalexin capsule 500 mg (ANDA)
|
Asclemed USA, Inc. |
Cephalexin |
D00906
|
|
FORZINITY injection 280 mg/3.5mL (NDA)
|
Stealth Biotherapeutics Inc. |
Elamipretide Hydrochloride |
D11542
|
|
Tamsulosin Hydrochloride capsule .4 mg (ANDA)
|
Chartwell RX, LLC |
Tamsulosin Hydrochloride |
D01024
|
|
Nitrofurantoin (monohydrate/macrocrystals) capsule 25 mg (ANDA)
|
NuCare Pharmaceuticals,Inc. |
Nitrofurantoin (monohydrate/macrocrystals) |
D00439
|
|
Colchicine tablet, film coated .6 mg (ANDA)
|
Chartwell RX, LLC |
Colchicine |
D00570
|
|
METHYLERGONOVINE MALEATE injection, solution .2 mg/mL (ANDA)
|
Pharmacist Pharmaceutical, LLC |
methylergonovine maleate |
D00680
|
captopril tablet 12.5 mg (ANDA)
captopril tablet 25 mg (ANDA)
captopril tablet 50 mg (ANDA)
captopril tablet 100 mg (ANDA)
|
Method Pharmaceuticals LLC |
captopril |
D00251
|
|
Acetaminophen injection, solution 1000 mg00mL (ANDA)
|
Mylan Institutional LLC |
Acetaminophen |
D00217
|
|
Levetiracetam injection 5 mg/mL (ANDA)
|
Hp Halden Pharma AS |
LEVETIRACETAM |
D00709
|
Focalin tablet 2.5 mg (NDA)
Focalin tablet 5 mg (NDA)
Focalin tablet 10 mg (NDA)
|
Sandoz Inc |
dexmethylphenidate hydrochloride |
D03721
|
Daurismo tablet, film coated 25 mg (NDA)
Daurismo tablet, film coated 100 mg (NDA)
|
Pfizer Laboratories Div Pfizer Inc |
glasdegib |
D11107
|
Omeprazole capsule, delayed release 40 mg (ANDA)
Omeprazole capsule, delayed release 20 mg (ANDA)
|
American Health Packaging |
Omeprazole |
D00455
|
|
TRIAMTERENE AND HYDROCHLOROTHIAZIDE capsule 25 mg (ANDA)
|
Chartwell RX, LLC |
TRIAMTERENE AND HYDROCHLOROTHIAZIDE |
D10269
|
|
Bimatoprost solution/ drops .3 mg/mL (ANDA)
|
Sandoz Inc |
Bimatoprost |
D02724
|
Amlodipine Besylate tablet 2.5 mg (ANDA)
Amlodipine Besylate tablet 5 mg (ANDA)
Amlodipine Besylate tablet 10 mg (ANDA)
|
Ascend Laboratories, LLC |
Amlodipine besylate |
D00615
|
|
Formoterol Fumarate Inhalation Solution solution 20 ug/2mL (ANDA)
|
Ritedose Pharmaceuticals, LLC |
formoterol fumarate dihydrate |
D05277
|
|
CHOLESTYRAMINE LIGHT powder, for suspension 4 g/5.7g (ANDA)
|
PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS |
cholestyramine light |
D02690
|
|
Amoxicillin capsule 500 mg (ANDA)
|
Asclemed USA, Inc. |
Amoxicillin |
D00229
|
|
Levetiracetam injection 15 mg/mL (ANDA)
|
Hp Halden Pharma AS |
LEVETIRACETAM |
D00709
|
|
Prednisone tablet 5 mg (ANDA)
|
Chartwell RX, LLC |
Prednisone |
D00473
|
|
Cefuroxime axetil tablet, film coated 500 mg (ANDA)
|
Redpharm Drug |
Cefuroxime axetil |
D00914
|
|
Oxycodone Hydrochloride solution 5 mg/5mL (NDA)
|
Redpharm Drug |
Oxycodone Hydrochloride |
D00847
|
|
Hydrocodone Bitartrate and Acetaminophen solution 325 mg5mL (ANDA)
|
Redpharm Drug |
Hydrocodone Bitartrate and Acetaminophen |
D00846
|
|
Doxepin Hydrochloride capsule 10 mg (ANDA)
|
Redpharm Drug |
Doxepin Hydrochloride |
D00814
|
|
Buprenorphine and Naloxone tablet 8 mg (ANDA)
|
Redpharm Drug |
Buprenorphine and Naloxone |
D10250
|
|
Magnesium Sulfate injection, solution 500 mg/mL (NDA)
|
ProPharma Distribution |
MAGNESIUM SULFATE HEPTAHYDRATE |
D01108
|
Ibuprofen tablet, film coated 400 mg (ANDA)
Ibuprofen tablet, film coated 600 mg (ANDA)
Ibuprofen tablet, film coated 800 mg (ANDA)
|
Chartwell RX, LLC |
Ibuprofen |
D00126
|
|
Diclofenac Potassium capsule, liquid filled 25 mg (ANDA)
|
Chartwell RX, LLC |
Diclofenac Potassium |
D00903
|
|
Ciprofloxacin tablet 250 mg (ANDA)
|
Redpharm Drug |
Ciprofolxacin |
D02216
|
Cardizem LA tablet, extended release 120 mg (NDA)
Cardizem LA tablet, extended release 180 mg (NDA)
Cardizem LA tablet, extended release 240 mg (NDA)
Cardizem LA tablet, extended release 300 mg (NDA)
Cardizem LA tablet, extended release 360 mg (NDA)
Cardizem LA tablet, extended release 420 mg (NDA)
|
Bausch Health US LLC |
Diltiazem Hydrochloride |
D00616
|
|
Oxybutynin Chloride tablet 5 mg (ANDA)
|
Upsher-Smith Laboratories, LLC |
Oxybutynin Chloride |
D00722
|
|
Hydrocortisone Rectal Suspension (Retention) suspension 100 mg/60mL (ANDA)
|
Chartwell RX LLC |
Hydrocortisone |
D00088
|
|
Folic Acid tablet 1 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC |
Folic Acid |
D00070
|
|
Budesonide tablet, film coated, extended release 9 mg (ANDA)
|
Actavis Pharma, Inc. |
Budesonide |
D00246
|
|
Buspirone hydrochloride tablet 5 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC |
Buspirone hydrochloride |
D00702
|
|
clonidine hydrochloride tablet .1 mg (ANDA)
|
VERITYRX, LLC |
Clonidine Hydrochloride |
D00604
|