| Product |
Company |
Generic name |
KEGG DRUG |
|
HUMALOG injection, solution 100 [iU]/mL (BLA)
|
A-S Medication Solutions |
Insulin lispro |
D04477
|
|
Gabapentin tablet 600 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC |
Gabapentin |
D00332
|
|
Butalbital, Acetaminophen and Caffeine tablet 50 mg (ANDA)
|
KVK-Tech, Inc. |
Butalbital, Acetaminophen and Caffeine |
D11850
|
|
Hydroxychloroquine sulfate tablet, film coated 200 mg (ANDA)
|
Quallent Pharmaceuticals Health LLC |
Hydroxychloroquine sulfate |
D02114
|
|
Vivacaine injection, solution 5 mg/mL (ANDA)
|
Septodont, Inc. |
bupivacaine hydrochloride and epinephrine bitartrate |
D11569
|
|
Triamterene and Hydrochlorothiazide capsule 37.5 mg (ANDA)
|
A-S Medication Solutions |
Triamterene and Hydrochlorothiazide |
D10269
|
|
adapalene and benzoyl peroxide gel .1 g00g (ANDA)
|
Padagis Israel Pharmaceuticals Ltd |
Adapalene and Benzoyl Peroxide |
D10792
|
|
Mesalamine tablet, delayed release 1.2 g (ANDA)
|
Camber Pharmaceuticals, Inc. |
Mesalamine |
D00377
|
Cefixime powder, for suspension 100 mg/5mL (ANDA)
Cefixime powder, for suspension 200 mg/5mL (ANDA)
|
Aurobindo Pharma Limited |
cefixime |
D07640
|
Cefdinir powder, for suspension 125 mg/5mL (ANDA)
Cefdinir powder, for suspension 250 mg/5mL (ANDA)
|
Aurobindo Pharma Limited |
Cefdinir |
D00917
|
Unithroid tablet 25 ug (NDA)
Unithroid tablet 50 ug (NDA)
Unithroid tablet 75 ug (NDA)
Unithroid tablet 88 ug (NDA)
Unithroid tablet 100 ug (NDA)
Unithroid tablet 112 ug (NDA)
Unithroid tablet 125 ug (NDA)
Unithroid tablet 137 ug (NDA)
Unithroid tablet 150 ug (NDA)
Unithroid tablet 175 ug (NDA)
Unithroid tablet 200 ug (NDA)
Unithroid tablet 300 ug (NDA)
|
Amneal Pharmaceuticals LLC |
levothyroxine sodium |
D01010
|
|
AMOXICILLIN AND CLAVULANATE POTASSIUM tablet, coated 875 mg (NDA AUTHORIZED GENERIC)
|
Proficient Rx LP |
amoxicillin and clavulanate potassium |
D06485
|
|
propranolol hydrochloride capsule, extended release 60 mg (ANDA)
|
Proficient Rx LP |
propranolol hydrochloride |
D00483
|
ZOMIG tablet, film coated 2.5 mg (ANDA)
ZOMIG tablet, film coated 5 mg (ANDA)
|
Amneal Pharmaceuticals LLC |
zolmitriptan |
D00415
|
|
Daunorubicin Hydrochloride injection 5 mg/mL (NDA)
|
Hikma Pharmaceuticals USA Inc. |
Daunorubicin Hydrochloride |
D01264
|
|
DULOXETINE DELAYED-RELEASE capsule, delayed release pellets 30 mg (ANDA)
|
Proficient Rx LP |
DULOXETINE HYDROCHLORIDE |
D01179
|
|
DALFAMPRIDINE tablet, film coated, extended release 10 mg (ANDA)
|
Aurobindo Pharma Limited |
DALFAMPRIDINE |
D04127
|
Ranolazine tablet, film coated, extended release 500 mg (ANDA)
Ranolazine tablet, film coated, extended release 1000 mg (ANDA)
|
Aurobindo Pharma Limited |
Ranolazine |
D05700
|
|
Ursodiol capsule 300 mg (ANDA)
|
Zydus Lifesciences Limited |
Ursodiol |
D00734
|
|
Potassium Chloride tablet, extended release 20 meq (ANDA)
|
Proficient Rx LP |
Potassium Chloride |
D02060
|
|
OSHIH kit (ANDA)
|
Aurobindo Pharma Limited |
norethindrone acetate and ethinyl estradiol and ferrous fumarate |
D04483
|
|
Temsirolimus kit (ANDA)
|
Accord Healthcare Inc. |
temsirolimus |
D06068
|
|
Tizanidine tablet 4 mg (ANDA)
|
Proficient Rx LP |
Tizanidine |
D00776
|
|
Tri-VyLibra kit (ANDA)
|
Afaxys Pharma, LLC |
Norgestimate and Ethinyl Estradiol |
D10590
|
|
Butalbital, Acetaminophen, Caffeine tablet 50 mg (ANDA)
|
A-S Medication Solutions |
Butalbital, Acetaminophen, and Caffeine |
D11850
|
PANTOPRAZOLE SODIUM tablet, delayed release 20 mg (ANDA)
PANTOPRAZOLE SODIUM tablet, delayed release 40 mg (ANDA)
|
Asclemed USA, Inc. |
PANTOPRAZOLE |
D02593
|
|
Voriconazole injection, powder, lyophilized, for solution 10 mg/mL (ANDA)
|
Fresenius Kabi USA, LLC |
Voriconazole |
D00578
|
Estazolam tablet 1 mg (ANDA)
Estazolam tablet 2 mg (ANDA)
|
Dr. Reddy's Labratories Inc. |
Estazolam |
D00311
|
Phentermine Hydrochloride tablet 37.5 mg (ANDA)
Phentermine Hydrochloride capsule 37.5 mg (ANDA)
|
KVK-TECH, Inc. |
Phentermine Hydrochloride |
D05459
|
Oxymorphone hydrochloride tablet, film coated, extended release 5 mg (ANDA)
Oxymorphone hydrochloride tablet, film coated, extended release 10 mg (ANDA)
Oxymorphone hydrochloride tablet, film coated, extended release 20 mg (ANDA)
Oxymorphone hydrochloride tablet, film coated, extended release 40 mg (ANDA)
Oxymorphone hydrochloride tablet, film coated, extended release 7.5 mg (ANDA)
Oxymorphone hydrochloride tablet, film coated, extended release 15 mg (ANDA)
Oxymorphone hydrochloride tablet, film coated, extended release 30 mg (ANDA)
|
Amneal Pharmaceuticals of New York LLC |
Oxymorphone hydrochloride |
D00844
|
Cefadroxil powder, for suspension 250 mg/5mL (ANDA)
Cefadroxil powder, for suspension 500 mg/5mL (ANDA)
|
Rising Pharma Holdings, Inc. |
Cefadroxil |
D02353
|
Fluoxetine capsule 10 mg (ANDA)
Fluoxetine capsule 20 mg (ANDA)
Fluoxetine capsule 40 mg (ANDA)
|
NorthStar Rx LLC |
Fluoxetine Hydrochloride |
D00823
|
|
Cefdinir capsule 300 mg (ANDA)
|
Rising Pharma Holdings, Inc. |
Cefdinir |
D00917
|
|
Duloxetine Delayed-Release capsule, delayed release pellets 40 mg (ANDA)
|
BluePoint Laboratories |
DULOXETINE HYDROCHLORIDE |
D01179
|
|
Azithromycin Dihydrate tablet, film coated 600 mg (ANDA)
|
Precision Dose, Inc. |
Azithromycin dihydrate |
D02134
|
|
Citalopram tablet, film coated 40 mg (ANDA)
|
A-S Medication Solutions |
Citalopram Hydrobromide |
D00822
|
Cefuroxime axetil tablet, film coated 250 mg (ANDA)
Cefuroxime axetil tablet, film coated 500 mg (ANDA)
|
A-S Medication Solutions |
Cefuroxime axetil |
D00914
|
|
Liothyronine Sodium tablet 5 ug (ANDA)
|
NuCare Pharmaceuticals,Inc. |
Liothyronine Sodium |
D01011
|
|
Lansoprazole capsule, delayed release 30 mg (ANDA)
|
NuCare Pharmaceuticals,Inc. |
Lansoprazole |
D00355
|
|
Hydroxyzine pamoate capsule 50 mg (ANDA)
|
NuCare Pharmaceuticals,Inc. |
Hydroxyzine Pamoate |
D01096
|