| Product |
Company |
Generic name |
KEGG DRUG |
Briviact tablet, film coated 10 mg (NDA)
Briviact tablet, film coated 25 mg (NDA)
Briviact tablet, film coated 50 mg (NDA)
Briviact tablet, film coated 75 mg (NDA)
Briviact tablet, film coated 100 mg (NDA)
Briviact solution 10 mg/mL (NDA)
Briviact injection, suspension 50 mg/5mL (NDA)
|
UCB, Inc. |
brivaracetam |
D08879
|
|
Sodium Phenylbutyrate tablet 500 mg (ANDA)
|
Par Health USA, LLC |
Sodium Phenylbutyrate Tablets, 500 mg |
D05868
|
|
SPIRONOLACTONE tablet 100 mg (ANDA)
|
NuCare Pharmaceuticals,Inc. |
SPIRONOLACTONE |
D00443
|
Zolpidem tartrate sublingual tablet 1.75 mg (ANDA)
Zolpidem tartrate sublingual tablet 3.5 mg (ANDA)
|
Par Health USA, LLC |
Zolpidem tartrate sublingual |
D00706
|
|
ADQUEY ointment 10 mg/g (NDA)
|
Acrotech Biopharma Inc |
Difamilast |
D11314
|
|
ATORVASTATIN CALCIUM tablet, film coated 80 mg (ANDA)
|
NuCare Pharmaceuticals, Inc. |
ATORVASTATIN CALCIUM |
D11095
|
|
Tadalafil tablet, film coated 5 mg (ANDA)
|
NuCare Pharmaceuticals, Inc. |
Tadalafil |
D02008
|
Metformin Hydrochloride tablet, film coated 500 mg (ANDA)
Metformin Hydrochloride tablet, film coated 850 mg (ANDA)
Metformin Hydrochloride tablet, film coated 1000 mg (ANDA)
|
Aurobindo Pharma Limited |
Metformin Hydrochloride |
D00944
|
|
NITROGLYCERIN tablet .4 mg (ANDA)
|
HF Acquisition Co LLC, DBA HealthFirst |
NITROGLYCERIN |
D00515
|
|
Cyclobenzaprine Hydrochloride tablet, film coated 10 mg (ANDA)
|
NuCare Pharmaceuticals, Inc. |
Cyclobenzaprine Hydrochloride |
D00772
|
|
Clindamycin Hydrochloride capsule 300 mg (ANDA)
|
NuCare Pharmaceuticals, Inc. |
Clindamycin Hydrochloride |
D02132
|
|
Tranexamic Acid injection 100 mg/mL (ANDA)
|
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. |
Tranexamic Acid |
D01136
|
|
Amoxicillin capsule 500 mg (ANDA)
|
Hikma Pharmaceuticals USA Inc. |
Amoxicillin |
D00229
|
|
Argatroban solution 125 mg25mL (NDA)
|
Plano Pharmaceuticals Inc. |
Argatroban |
D00181
|
|
Ketorolac Tromethamine tablet, film coated 10 mg (ANDA)
|
Injecta Medcial LLC |
Ketorolac Tromethamine |
D00813
|
|
Glipizide tablet 5 mg (ANDA)
|
Coupler LLC |
Glipizide |
D00335
|
|
Carvedilol tablet, film coated 6.25 mg (ANDA)
|
Coupler LLC |
Carvedilol |
D00255
|
|
Lithium Carbonate ER tablet 450 mg (ANDA)
|
Coupler LLC |
Lithium Carbonate |
D00801
|
|
Olanzapine tablet, film coated 20 mg (ANDA)
|
Coupler LLC |
Olanzapine |
D00454
|
|
ESTRADIOL gel .75 mg.25g (ANDA)
|
Encube Ethicals, Inc. |
Estradiol |
D00105
|
CALCITRIOL capsule .25 ug (ANDA)
CALCITRIOL capsule .5 ug (ANDA)
|
EPIC PHARMA LLC |
CALCITRIOL |
D00129
|
|
Entacapone tablet 200 mg (ANDA)
|
Macleods Pharmaceuticals Limited |
Entacapone |
D00781
|
|
Olmesartan Medoxomil tablet, film coated 5 mg (ANDA)
|
Bryant Ranch Prepack |
Olmesartan Medoxomil |
D01204
|
|
Varibar Nectar suspension 400 mg/mL (NDA)
|
E-Z-EM Canada Inc |
barium sulfate |
D02052
|
|
Ampicillin and Sulbactam injection, powder, for solution 2 g/20mL (ANDA)
|
WG Critical Care, LLC |
Ampicillin and Sulbactam |
D02065
|
|
Diltiazem Hydrochloride tablet 30 mg (ANDA)
|
Bryant Ranch Prepack |
Diltiazem hydrochloride |
D00616
|
|
Midazolam hydrochloride injection, solution 1 mg/mL (ANDA)
|
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. |
Midazolam hydrochloride |
D00696
|
dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate capsule, extended release 1.25 mg (ANDA)
dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate capsule, extended release 2.5 mg (ANDA)
dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate capsule, extended release 3.75 mg (ANDA)
dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate capsule, extended release 5 mg (ANDA)
dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate capsule, extended release 6.25 mg (ANDA)
dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate capsule, extended release 7.5 mg (ANDA)
|
Granules Pharmaceuticals Inc. |
dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate |
D11624
|
|
Halaven injection 1 mg/2mL (NDA)
|
BSP Pharmaceuticals SpA |
eribulin mesylate |
D08914
|
|
atomoxetine capsule 60 mg (ANDA)
|
Bryant Ranch Prepack |
atomoxetine |
D02574
|
Varenicline tablet, film coated .5 mg (ANDA)
Varenicline tablet, film coated 1 mg (ANDA)
Varenicline kit (ANDA)
|
Par Health USA, LLC |
varenicline tartrate |
D06282
|
Azilsartan medoxomil tablet 40 mg (ANDA)
Azilsartan medoxomil tablet 80 mg (ANDA)
|
Lupin Pharmaceuticals, Inc. |
Azilsartan medoxomil |
D08865
|
Sumatriptan tablet 25 mg (ANDA)
Sumatriptan tablet 50 mg (ANDA)
Sumatriptan tablet 100 mg (ANDA)
|
Aurobindo Pharma Limited |
Sumatriptan Succinate |
D00676
|
|
ATOVAQUONE suspension 750 mg/5mL (ANDA)
|
Amneal Pharmaceuticals LLC |
ATOVAQUONE |
D00236
|
|
Gabapentin capsule 300 mg (ANDA)
|
NuCare Pharmaceuticals,Inc. |
Gabapentin |
D00332
|
|
Brimonidine Tartrate/Timolol Maleate solution/ drops 2 mg/mL (ANDA)
|
Glenmark Pharmaceuticals Inc., USA |
Brimonidine Tartrate and Timolol Maleate |
D10298
|
Adzenys XR-ODT tablet, orally disintegrating 18.8 mg (NDA)
Adzenys XR-ODT tablet, orally disintegrating 3.1 mg (NDA)
Adzenys XR-ODT tablet, orally disintegrating 6.3 mg (NDA)
Adzenys XR-ODT tablet, orally disintegrating 9.4 mg (NDA)
Adzenys XR-ODT tablet, orally disintegrating 12.5 mg (NDA)
Adzenys XR-ODT tablet, orally disintegrating 15.7 mg (NDA)
|
Neos Therapeutics Brands, LLC |
Amphetamine |
D07445
|
Lisdexamfetamine dimesylate tablet, chewable 10 mg (ANDA)
Lisdexamfetamine dimesylate tablet, chewable 20 mg (ANDA)
Lisdexamfetamine dimesylate tablet, chewable 30 mg (ANDA)
Lisdexamfetamine dimesylate tablet, chewable 40 mg (ANDA)
Lisdexamfetamine dimesylate tablet, chewable 50 mg (ANDA)
Lisdexamfetamine dimesylate tablet, chewable 60 mg (ANDA)
|
Granules Pharmaceuticals Inc. |
Lisdexamfetamine dimesylate |
D04747
|
LISDEXAMFETAMINE DIMESYLATE capsule 10 mg (ANDA)
LISDEXAMFETAMINE DIMESYLATE capsule 20 mg (ANDA)
LISDEXAMFETAMINE DIMESYLATE capsule 30 mg (ANDA)
LISDEXAMFETAMINE DIMESYLATE capsule 40 mg (ANDA)
LISDEXAMFETAMINE DIMESYLATE capsule 50 mg (ANDA)
LISDEXAMFETAMINE DIMESYLATE capsule 60 mg (ANDA)
LISDEXAMFETAMINE DIMESYLATE capsule 70 mg (ANDA)
|
Granules Pharmaceuticals Inc. |
LISDEXAMFETAMINE DIMESYLATE |
D04747
|
celecoxib capsule 50 mg (ANDA)
celecoxib capsule 100 mg (ANDA)
celecoxib capsule 200 mg (ANDA)
celecoxib capsule 400 mg (ANDA)
|
Macleods Pharmaceuticals Limited |
celecoxib |
D00567
|