| Product |
Company |
Generic name |
KEGG DRUG |
|
Fludeoxyglucose F 18 injection 240 mCi/mL (ANDA)
|
Mayo Clinic |
Fludeoxyglucose F-18 |
D01843
|
|
Cyclobenzaprine Hydrochloride tablet, film coated 5 mg (ANDA)
|
Northwind Health Company, LLC |
Cyclobenzaprine Hydrochloride |
D00772
|
|
Zoledronic Acid injection, solution, concentrate 4 mg/5mL (ANDA)
|
BPI Labs LLC |
zoledronic acid |
D01968
|
|
Sterile Cord Blood Collection Unit (MSC128D) injection, solution 94.8 mg/29mL (NDA)
|
Maco Productions |
Anticoagulant Citrate Phosphate Dextrose Solution |
D02955
|
RUFINAMIDE tablet, film coated 200 mg (ANDA)
RUFINAMIDE tablet, film coated 400 mg (ANDA)
|
Lupin Pharmaceuticals, Inc. |
rufinamide |
D05775
|
|
Mycophenolate Mofetil injection, powder, lyophilized, for solution 500 mg/20mL (ANDA)
|
BPI Labs LLC |
Mycophenolate Mofetil hydrochloride |
D05094
|
|
EPINEPHRINE injection 1 mg/mL (NDA)
|
BPI Labs, LLC |
EPINEPHRINE |
D00095
|
|
RUFINAMIDE suspension 40 mg/mL (ANDA)
|
Aurobindo Pharma Limited |
RUFINAMIDE |
D05775
|
|
Fulvestrant injection 50 mg/mL (ANDA)
|
Chia Tai Tianqing Pharmaceutical Group Co., Ltd. |
fulvestrant |
D01161
|
|
leuprolide acetate kit (ANDA)
|
Amneal Pharmaceuticals LLC |
leuprolide acetate |
D00989
|
|
Lidocaine Hydrochloride injection, solution 20 mg/mL (ANDA)
|
Cardinal Health 107, LLC |
LIDOCAINE HYDROCHLORIDE |
D02086
|
|
Divalproex Sodium tablet, extended release 250 mg (ANDA)
|
Major Pharmaceuticals |
Divalproex Sodium |
D00304
|
|
Regadenoson injection, solution .08 mg/mL (ANDA)
|
Indies Pharma Jamaica Limited |
Regadenoson |
D12568
|
|
CARBOPLATIN injection, solution 10 mg/mL (ANDA)
|
BPI Labs LLC |
Carboplatin |
D01363
|
|
Acetylcysteine injection, solution 6 g/30mL (ANDA)
|
Eugia US LLC |
Acetylcysteine |
D00221
|
|
Epinephrine injection, solution, concentrate 1 mg/mL (NDA)
|
BPI Labs, LLC |
Epinephrine |
D00095
|
|
Naloxone Hydrochloride injection, solution 1 mg/mL (ANDA)
|
BPI Labs LLC |
Naloxone Hydrochloride |
D01340
|
|
Macrilen granule, for solution 60 mg/mg (NDA)
|
Novo Nordisk |
Macimorelin acetate |
D10562
|
|
Sevelamer Carbonate tablet, film coated 800 mg (ANDA)
|
Cardinal Health 107, LLC |
Sevelamer Carbonate |
D06642
|
Naproxen Sodium tablet 275 mg (ANDA)
Naproxen Sodium tablet 550 mg (ANDA)
Naproxen tablet 250 mg (ANDA)
Naproxen tablet 375 mg (ANDA)
Naproxen tablet 500 mg (ANDA)
|
Glenmark Pharmaceuticals Inc., USA |
Naproxen Sodium |
D00118
|
|
Leucoflex CGP kit (NDA)
|
Maco Productions |
Anticoagulant Citrate Phosphate Dextrose Solution with Additive Solution AS-1 |
D02955
|
|
hydroxyzine pamoate capsule 25 mg (ANDA)
|
Cardinal Health 107, LLC |
hydroxyzine pamoate |
D01096
|
|
FOSAPREPITANT injection, powder, lyophilized, for solution 150 mg/5mL (ANDA)
|
Chia Tai Tianqing Pharmaceutical Group Co., Ltd. |
FOSAPREPITANT DIMEGLUMINE |
D06597
|
|
EPINEPHRINE injection 1 mg/mL (NDA)
|
BPI Labs, LLC |
EPINEPHRINE |
D00095
|
|
Sterile Cord Blood Collection Unit (MSC127D) injection, solution 114.5 mg/35mL (NDA)
|
Maco Productions |
Anticoagulant Citrate Phosphate Dextrose Solution |
D02955
|
|
Lidocaine Hydrochloride and Epinephrine injection, solution 10 ug/mL (ANDA)
|
Cardinal Health 107, LLC |
lidocaine hydrochloride and epinephrine |
D04052
|
|
Hydroxychloroquine Sulfate tablet, film coated 200 mg (ANDA)
|
Amneal Pharmaceuticals NY LLC |
Hydroxychloroquine Sulfate |
D02114
|
|
Solu-Medrol injection, powder, for solution 40 mg/mL (NDA)
|
Cardinal Health 107, LLC |
methylprednisolone sodium succinate |
D00751
|
|
Choline C 11 injection 33.1 mCi/mL (NDA)
|
Mayo Clinic |
Choline C-11 |
D10498
|
|
Torisel kit (NDA)
|
Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. |
temsirolimus |
D06068
|
|
Heparin Sodium injection, solution 5000 [USP'U]/mL (ANDA)
|
Cardinal Health 107, LLC |
HEPARIN SODIUM |
D02112
|
|
Emtricitabine and Tenofovir Disoproxil Fumarate tablet, film coated 200 mg (ANDA)
|
Major Pharmaceuticals |
Emtricitabine and Tenofovir Disoproxil Fumarate |
D02297
|
ZOLPIDEM TARTRATE tablet, extended release 6.25 mg (ANDA)
ZOLPIDEM TARTRATE tablet, extended release 12.5 mg (ANDA)
|
Lupin Pharmaceuticals, Inc. |
Zolpidem Tartrate |
D00706
|
Potassium Chloride solution 20 meq5mL (ANDA)
Potassium Chloride solution 40 meq5mL (ANDA)
|
BPI Labs LLC |
Potassium Chloride |
D02060
|
|
Ammonia N 13 injection, solution 37.5 mCi/mL (ANDA)
|
Mayo Clinic |
ammonia n-13 |
D02915
|
|
Levofloxacin solution/ drops 15 mg/mL (ANDA)
|
BPI LABS LLC |
Levofloxacin |
D00588
|
|
YONSA tablet 125 mg (NDA)
|
Sun Pharmaceutical Industries, Inc. |
abiraterone acetate |
D09701
|
Dextrose injection, solution 12500 mg/250mL (ANDA)
Dextrose injection, solution 25000 mg/500mL (ANDA)
Dextrose injection, solution 2500 mg/50mL (ANDA)
Dextrose injection, solution 5000 mg00mL (ANDA)
|
Fresenius Kabi USA, LLC |
Dextrose Monohydrate |
D02325
|
Lamotrigine tablet 100 mg (ANDA)
Lamotrigine tablet 25 mg (ANDA)
|
Cardinal Health 107, LLC |
Lamotrigine |
D00354
|
|
Levemir injection, solution 100 [iU]/mL (BLA)
|
Novo Nordisk |
insulin detemir |
D04539
|