| Product |
Company |
Generic name |
KEGG DRUG |
|
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
|
|
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 .92 g/35mL (NDA)
|
Maco Productions |
Anticoagulant Citrate Phosphate Dextrose Solution |
D02955
|
|
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
|
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
|
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
|
EPINEPHRINE injection 1 mg/mL (NDA)
EPINEPHRINE injection 30 mg/30mL (NDA)
|
BPI Labs, LLC |
EPINEPHRINE |
D00095
|
|
RETHYMIC implant 22000 mm (BLA)
|
Sumitomo Pharma America, Inc. |
allogenic thymocyte-depleted thymus tissue-agdc |
|
|
Sodium Fluoride F 18 injection 91.5 mCi/mL (ANDA)
|
Mayo Clinic |
sodium fluoride F 18 |
D05860
|
|
Oxcarbazepine suspension 300 mg/5mL (ANDA)
|
Chartwell Governmental & Specialty RX, LLC. |
Oxcarbazepine |
D00533
|
DOXYCYCLINE HYCLATE DELAYED RELEASE tablet, delayed release 75 mg (ANDA)
DOXYCYCLINE HYCLATE DELAYED RELEASE tablet, delayed release 100 mg (ANDA)
DOXYCYCLINE HYCLATE DELAYED RELEASE tablet, delayed release 150 mg (ANDA)
DOXYCYCLINE HYCLATE DELAYED RELEASE tablet, delayed release 200 mg (ANDA)
|
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. |
doxycycline hyclate |
D02129
|
Clomipramine Hydrochloride capsule 75 mg (ANDA)
Clomipramine Hydrochloride capsule 50 mg (ANDA)
Clomipramine Hydrochloride capsule 25 mg (ANDA)
|
Leading Pharma, LLC |
Clomipramine Hydrochloride |
D00811
|
Nitroglycerin tablet .3 mg (ANDA)
Nitroglycerin tablet .4 mg (ANDA)
Nitroglycerin tablet .6 mg (ANDA)
|
Glenmark Pharmaceuticals Inc., USA |
Nitroglycerin |
D00515
|
|
Clindamycin Hydrochloride capsule 300 mg (ANDA)
|
Redpharm Drug |
Clindamycin Hydrochloride |
D02132
|
|
prednisone tablet 20 mg (ANDA)
|
Redpharm Drug |
prednisone |
D00473
|
|
Cefadroxil capsule 500 mg (ANDA)
|
Redpharm Drug |
Cefadroxil |
D02353
|
|
Oxycodone and Acetaminophen tablet 5 mg (ANDA)
|
RedPharm Drug |
Oxycodone and Acetaminophen |
D02153
|
|
Omeprazole capsule, delayed release 20 mg (ANDA)
|
Redpharm Drug |
Omeprazole |
D00455
|
|
Oseltamivir Phosphate capsule 75 mg (ANDA)
|
Redpharm Drug |
oseltamivir phosphate |
D00900
|
|
ACYCLOVIR suspension 200 mg/5mL (ANDA)
|
Aurobindo Pharma Limited |
ACYCLOVIR |
D00222
|
Pramipexole Dihydrochloride tablet .125 mg (ANDA)
Pramipexole Dihydrochloride tablet .25 mg (ANDA)
Pramipexole Dihydrochloride tablet .5 mg (ANDA)
Pramipexole Dihydrochloride tablet .75 mg (ANDA)
Pramipexole Dihydrochloride tablet 1 mg (ANDA)
Pramipexole Dihydrochloride tablet 1.5 mg (ANDA)
|
ScieGen Pharmaceuticals Inc |
Pramipexole Dihydrochloride |
D00559
|
|
Dicyclomine hydrochloride tablet 20 mg (ANDA)
|
Redpharm Drug |
Dicyclomine hydrochloride |
D00717
|
|
SEZABY injection 100 mg (NDA)
|
Sun Pharmaceutical Industries, Inc. |
phenobarbital sodium |
D00701
|
|
Azelaic Acid Gel gel .15 g/g (ANDA)
|
Encube Ethicals, Inc. |
Azelaic Acid |
D03034
|
|
CTEXLI tablet, film coated 250 mg (NDA)
|
Mirum Pharmaceuticals Inc. |
chenodiol |
D00163
|
|
Acetaminophen and Codeine Phosphate tablet 300 mg (ANDA)
|
Aurolife Pharma, LLC |
Acetaminophen and Codeine Phosphate |
D02146
|
XELSTRYM patch, extended release 4.5 mg (NDA)
XELSTRYM patch, extended release 9 mg (NDA)
XELSTRYM patch, extended release 13.5 mg (NDA)
XELSTRYM patch, extended release 18 mg (NDA)
|
Noven Therapeutics, LLC |
DEXTROAMPHETAMINE |
D03740
|