| Product |
Company |
Generic name |
KEGG DRUG |
|
RYZNEUTA injection 20 mg/mL (BLA)
|
Acrotech Biopharma Inc |
efbemalenograstim alfa-vuxw |
D11986
|
|
Levetiracetam injection, solution 500 mg/5mL (ANDA)
|
Eugia US LLC |
Levetiracetam |
D00709
|
|
Sumatriptan and Naproxen Sodium tablet, film coated 500 mg (ANDA)
|
NorthStar RxLLC |
Sumatriptan and Naproxen Sodium |
D11577
|
|
Palonosetron Hydrochloride injection, solution .25 mg/5mL (ANDA)
|
Eugia US LLC |
Palonosetron Hydrochloride |
D05343
|
|
Ampicillin Sodium and Sulbactam Sodium injection, powder, for solution 10 g5g (ANDA)
|
ONESOURCE SPECIALTY PHARMA LIMITED |
ampicillin sodium, sulbactam sodium |
D02065
|
|
Docetaxel injection 10 mg/mL (ANDA)
|
Baxter Healthcare Corporation |
Docetaxel |
D07866
|
|
Acyclovir suspension 200 mg/5mL (ANDA)
|
Advagen Pharma Limited |
Acyclovir |
D00222
|
Rivaroxaban tablet, film coated 2.5 mg (ANDA)
Rivaroxaban tablet, film coated 10 mg (ANDA)
Rivaroxaban tablet, film coated 15 mg (ANDA)
Rivaroxaban tablet, film coated 20 mg (ANDA)
|
Indoco Remedies Limited |
Rivaroxaban |
D07086
|
|
Ephedrine Sulfate injection 50 mg/mL (ANDA)
|
Eugia US LLC |
Ephedrine Sulfate |
D04018
|
Ampicillin Sodium and Sulbactam Sodium injection, powder, for solution 2 g (ANDA)
Ampicillin Sodium and Sulbactam Sodium injection, powder, for solution 1 g (ANDA)
|
Armas Pharmaceuticals Inc. |
ampicillin sodium, sulbactam sodium |
D02065
|
Metoprolol Succinate tablet, extended release 25 mg (ANDA)
Metoprolol Succinate tablet, extended release 100 mg (ANDA)
Metoprolol Succinate tablet, extended release 200 mg (ANDA)
Metoprolol Succinate tablet, extended release 50 mg (ANDA)
|
Granules India Ltd |
Metoprolol Succinate |
D00635
|
|
ZTALMY suspension 50 mg/mL (NDA)
|
Immedica Pharma US Inc |
ganaxolone |
D04300
|
|
Clonidine hydrochloride tablet, extended release .1 mg (ANDA)
|
Ajanta Pharma USA Inc. |
Clonidine hydrochloride |
D00604
|
|
HYDRALAZINE HYDROCHLORIDE injection 20 mg/mL (ANDA)
|
Eugia US LLC |
HYDRALAZINE HYDROCHLORIDE |
D01302
|
|
Nitrogen gas 995 mL/L (NDA)
|
Westair Gases & Equipment, Inc. |
Nitrogen |
D00083
|
Plegridy injection, solution 125 ug/.5mL (BLA)
Plegridy Pen injection, solution 125 ug/.5mL (BLA)
Plegridy Pen kit (BLA)
Plegridy kit (BLA)
|
Biogen Inc. |
peginterferon beta-1a |
D10483
|
|
DOXORUBICIN HYDROCHLORIDE injection, suspension, liposomal 2 mg/mL (ANDA)
|
Lupin Pharmaceuticals, Inc. |
DOXORUBICIN HYDROCHLORIDE |
D01275
|
|
Doxycycline injection, powder, lyophilized, for solution 100 mg0mL (ANDA)
|
Camber Pharmaceuticals, Inc. |
Doxycycline |
D02129
|
|
Oxygen gas 998 mL/L (NDA)
|
County Welding Supply Co. |
Oxygen |
D00003
|
|
Zonisamide capsule 25 mg (ANDA)
|
Bryant Ranch Prepack |
Zonisamide |
D00538
|
|
Carbon Dioxide gas 990 mL/L (NDA)
|
General Air Service & Supply Co. |
Carbon Dioxide |
D00004
|
|
Oxygen gas 990 mL/L (NDA)
|
Gulf Coast Gas & Equipment, LLC |
Oxygen |
D00003
|
Sevelamer Carbonate tablet, film coated 800 mg (NDA AUTHORIZED GENERIC)
Sevelamer Carbonate powder, for suspension .8 g (NDA AUTHORIZED GENERIC)
Sevelamer Carbonate powder, for suspension 2.4 g (NDA AUTHORIZED GENERIC)
|
Sanofi-Aventis U.S. LLC |
Sevelamer Carbonate |
D06642
|
HYZAAR tablet, film coated 12.5 mg (NDA)
HYZAAR tablet, film coated 25 mg (NDA)
|
Organon LLC |
losartan potassium and hydrochlorothiazide |
D07895
|
Risperidone tablet .25 mg (ANDA)
Risperidone tablet .5 mg (ANDA)
Risperidone tablet 1 mg (ANDA)
Risperidone tablet 2 mg (ANDA)
Risperidone tablet 3 mg (ANDA)
Risperidone tablet 4 mg (ANDA)
|
Golden State Medical Supply, Inc. |
Risperidone |
D00426
|
|
Oxygen gas 995 mL/L (NDA)
|
General Air Service & Supply Co |
Oxygen |
D00003
|
|
Diclofenac Sodium solution 20 mg/g (ANDA)
|
Lupin Pharmaceuticals, Inc. |
Diclofenac Sodium |
D00904
|
|
Air gas 210 mL/L (NDA)
|
General Air Service & Supply Co |
Air |
D03043
|
|
Helium/Oxygen Mixture 80/20 gas 200 mL/L (NDA)
|
General Air Service & Supply Co. |
Helium/Oxygen Mixture 80/20 |
|
|
Air gas 995 mL/L (NDA)
|
Westair Gases & Equipment, Inc. |
Air |
D03043
|
|
Carbogen gas 950 mL/L (NDA)
|
Westair Gases & Equipment, Inc. |
Carbogen |
|
|
Carbon Dioxide Oxygen Mixture gas 800 mL/L (NDA)
|
General Air Service & Supply Co |
Carbon Dioxide Oxygen Mixture |
|
|
Carbon Dioxide Air Mixture gas 50 mL/L (NDA)
|
General Air Service & Supply Co |
Carbon Dioxide Air Mixture |
D00004
|
|
Helium/Oxygen Mixture 70/30 gas 300 mL/L (NDA)
|
General Air Service & Supply Co |
Helium/Oxygen Mixture 70/30 |
|
|
DESOXIMETASONE ointment 2.5 mg/g (ANDA)
|
Lupin Pharmaceuticals, Inc. |
DESOXIMETASONE |
D03697
|
Methocarbamol tablet, film coated 500 mg (ANDA)
Methocarbamol tablet, film coated 750 mg (ANDA)
|
Asclemed USA, Inc. |
Methocarbamol |
D00402
|
|
BUPROPION HYDROCHLORIDE (SR) tablet, extended release 150 mg (ANDA)
|
Dr. Reddy's Laboratories Inc |
Bupropion Hydrochloride |
D00817
|
|
Carbon Dioxide gas 995 mL/L (NDA)
|
Westair Gases & Equipment, Inc. |
Carbon Dioxide |
D00004
|
|
Nitrogen gas 99 L00L (NDA)
|
Young Welding Supply, Inc |
Nitrogen |
D00083
|
|
OXYGEN gas 99 L00L (NDA)
|
Bradshaw's Industrial Supply, Inc. dba Interstate Welding Supply |
OXYGEN |
D00003
|