| Product |
Company |
Generic name |
KEGG DRUG |
|
NITROGEN gas 99 L00L (NDA)
|
Aspen Air U.S., LLC |
NITROGEN |
D00083
|
|
Amantadine Hydrochloride capsule 100 mg (ANDA)
|
Chartwell RX, LLC |
Amantadine Hydrochloride |
D00777
|
Felbamate tablet 400 mg (ANDA)
Felbamate tablet 600 mg (ANDA)
|
Amneal Pharmaceuticals LLC |
Felbamate |
D00536
|
APREPITANT capsule 40 mg (ANDA)
APREPITANT capsule 80 mg (ANDA)
APREPITANT capsule 125 mg (ANDA)
APREPITANT kit (ANDA)
|
Torrent Pharmaceuticals Limited |
APREPITANT |
D02968
|
|
Ibuprofen tablet, film coated 800 mg (ANDA)
|
A-S Medication Solutions |
Ibuprofen |
D00126
|
nitrofurantoin (macrocrystals) capsule 100 mg (ANDA)
nitrofurantoin (macrocrystals) capsule 25 mg (ANDA)
|
Aurobindo Pharma Limited |
nitrofurantoin (macrocrystals) |
D00439
|
|
Ibuprofen tablet, film coated 600 mg (ANDA)
|
A-S Medication Solutions |
Ibuprofen |
D00126
|
|
Diethylpropion Hydrochloride tablet 25 mg (ANDA)
|
Chartwell RX, LLC. |
Diethylpropion Hydrochloride |
D03801
|
|
acetazolamide capsule 500 mg (ANDA)
|
Zydus Pharmaceuticals (USA) Inc. |
acetazolamide |
D00218
|
|
Bepotastine Besilate solution 15 mg/mL (ANDA)
|
Somerset Therapeutics, LLC |
Bepotastine Besilate |
D01654
|
Dicyclomine Hydrochloride tablet 20 mg (ANDA)
Dicyclomine Hydrochloride capsule 10 mg (ANDA)
|
Chartwell RX, LLC |
Dicyclomine Hydrochloride |
D00717
|
SENSORCAINE MPF injection, solution 5 mg/mL (NDA)
SENSORCAINE MPF injection, solution 2.5 mg/mL (NDA)
|
Fresenius Kabi USA, LLC |
BUPIVACAINE HYDROCHLORIDE and EPINEPHRINE BITARTRATE |
D11569
|
SERTRALINE HYDROCHLORIDE tablet 25 mg (ANDA)
SERTRALINE HYDROCHLORIDE tablet 50 mg (ANDA)
SERTRALINE HYDROCHLORIDE tablet 100 mg (ANDA)
|
Camber Pharmaceuticals, Inc. |
sertraline hydrochloride |
D00825
|
Benazepril hydrochloride tablet 5 mg (ANDA)
Benazepril hydrochloride tablet 10 mg (ANDA)
Benazepril hydrochloride tablet 20 mg (ANDA)
Benazepril hydrochloride tablet 40 mg (ANDA)
|
Chartwell RX, LLC |
Benazepril hydrochloride |
D00620
|
|
Acetazolamide capsule, extended release 500 mg (ANDA)
|
Chartwell RX, LLC |
Acetazolamide |
D00218
|
|
Travoprost solution/ drops .04 mg/mL (ANDA)
|
Somerset Therapeutics, LLC |
Travoprost (Isomer Free) |
D01964
|
Acetazolamide tablet 125 mg (ANDA)
Acetazolamide tablet 250 mg (ANDA)
|
Chartwell RX, LLC |
Acetazolamide |
D00218
|
|
Aripiprazole solution 1 mg/mL (ANDA)
|
Aurobindo Pharma Limited |
Aripiprazole |
D01164
|
|
Diethylpropion Hydrochloride ER tablet, extended release 75 mg (ANDA)
|
Chartwell RX, LLC. |
Diethylpropion Hydrochloride |
D03801
|
|
Moxifloxacin solution/ drops 5 mg/mL (ANDA)
|
Bryant Ranch Prepack |
moxifloxacin |
D11618
|
|
ETHOSUXIMIDE capsule 250 mg (ANDA)
|
Chartwell RX, LLC |
ETHOSUXIMIDE |
D00539
|
|
Glipizide tablet 5 mg (ANDA)
|
Bryant Ranch Prepack |
Glipizide |
D00335
|
Pramipexole dihydrochloride tablet .25 mg (ANDA)
Pramipexole dihydrochloride tablet .5 mg (ANDA)
|
NCS HealthCare of KY, LLC dba Vangard Labs |
Pramipexole dihydrochloride |
D00559
|
|
asparlas injection, solution 750 U/mL (BLA)
|
Servier Pharmaceuticals LLC |
calaspargase pegol |
D10096
|
Tiopronin tablet, delayed release 300 mg (ANDA)
Tiopronin tablet, delayed release 100 mg (ANDA)
|
Teva Pharmaceuticals, Inc. |
Tiopronin |
D01430
|
|
Lorazepam tablet 1 mg (ANDA)
|
NuCare Pharmaceuticals,Inc. |
Lorazepam |
D00365
|
Enalapril maleate tablet 2.5 mg (ANDA)
Enalapril maleate tablet 5 mg (ANDA)
Enalapril maleate tablet 10 mg (ANDA)
Enalapril maleate tablet 20 mg (ANDA)
|
Chartwell RX, LLC |
Enalapril maleate |
D00621
|
Tretinoin cream .25 mg/g (NDA AUTHORIZED GENERIC)
Tretinoin cream .5 mg/g (NDA AUTHORIZED GENERIC)
Tretinoin cream 1 mg/g (NDA AUTHORIZED GENERIC)
Tretinoin gel .1 mg/g (NDA AUTHORIZED GENERIC)
Tretinoin gel .25 mg/g (NDA AUTHORIZED GENERIC)
|
Mylan Pharmaceuticals Inc. |
Tretinoin |
D00094
|
|
Glipizide tablet 10 mg (ANDA)
|
Bryant Ranch Prepack |
Glipizide |
D00335
|
Nadolol tablet 20 mg (ANDA)
Nadolol tablet 40 mg (ANDA)
Nadolol tablet 80 mg (ANDA)
|
Amneal Pharmaceuticals NY LLC |
Nadolol |
D00432
|
|
Aphexda injection, powder, lyophilized, for solution 62 mg.7mL (NDA)
|
BioLineRx USA Inc |
Motixafortide |
D12282
|
|
Ketorolac Tromethamine tablet, film coated 10 mg (ANDA)
|
A-S Medication Solutions |
Ketorolac Tromethamine |
D00813
|
|
DIAZEPAM tablet 5 mg (ANDA)
|
NuCare Pharmaceuticals, Inc |
DIAZEPAM |
D00293
|
|
Lincomycin injection 3000 mg0mL (ANDA)
|
PAI Holdings, LLC dba PAI Pharma |
Lincomycin Hydrochloride |
D02346
|
|
Ibuprofen tablet 800 mg (ANDA)
|
NuCare Pharmaceuticals, Inc. |
Ibuprofen |
D00126
|
|
AUVI-Q injection, solution .15 mg/.15mL (NDA)
|
HF Acquisition Co LLC, DBA HealthFirst |
AUVI-Q |
D00095
|
|
AUVI-Q injection, solution .3 mg/.3mL (NDA)
|
HF Acquisition Co LLC, DBA HealthFirst |
AUVI-Q |
D00095
|
|
ATORVASTATIN CALCIUM tablet, film coated 20 mg (ANDA)
|
A-S Medication Solutions |
ATORVASTATIN CALCIUM |
D11095
|
isoproterenol hydrochloride injection, solution .2 mg/mL (ANDA)
isoproterenol hydrochloride injection, solution 1 mg/5mL (ANDA)
|
Gland Pharma Limited |
isoproterenol hydrochloride |
D01390
|
meloxicam tablet 7.5 mg (ANDA)
meloxicam tablet 15 mg (ANDA)
|
Quallent Pharmaceuticals Health LLC |
meloxicam |
D00969
|