Product |
Company |
Generic name |
KEGG DRUG |
TOBRAMYCIN AND DEXAMETHASONE suspension/ drops 1 mg/mL (ANDA)
|
Padagis US LLC
|
tobramycin and dexamethasone
|
D11178
|
KETOCONAZOLE tablet 200 mg (ANDA)
|
NuCare Pharmaceuticals,Inc.
|
KETOCONAZOLE
|
D00351
|
Buspirone Hydrochloride tablet 15 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC
|
Buspirone Hydrochloride
|
D00702
|
Exondys 51 injection 50 mg/mL (NDA)
|
Sarepta Therapeutics, Inc.
|
eteplirsen
|
D09900
|
Vyondys 53 injection 50 mg/mL (NDA)
|
Sarepta Therapeutics, Inc.
|
golodirsen
|
D11707
|
Ambien CR tablet, coated 6.25 mg (NDA)
Ambien CR tablet, coated 12.5 mg (NDA)
|
sanofi-aventis U.S. LLC
|
zolpidem tartrate
|
D00706
|
Cephalexin tablet 250 mg (ANDA)
Cephalexin tablet 500 mg (ANDA)
|
Teva Pharmaceuticals USA, Inc.
|
Cephalexin
|
D00906
|
Doxepin Hydrochloride capsule 10 mg (ANDA)
Doxepin Hydrochloride capsule 25 mg (ANDA)
Doxepin Hydrochloride capsule 50 mg (ANDA)
Doxepin Hydrochloride capsule 75 mg (ANDA)
Doxepin Hydrochloride capsule 100 mg (ANDA)
|
JUBILANT CADISTA PHARMACEUTICALS INC.
|
Doxepin Hydrochloride
|
D00814
|
Cephalexin capsule 250 mg (ANDA)
Cephalexin capsule 500 mg (ANDA)
Cephalexin powder, for suspension 125 mg/5mL (ANDA)
Cephalexin powder, for suspension 250 mg/5mL (ANDA)
|
Teva Pharmaceuticals USA, Inc.
|
Cephalexin
|
D00906
|
Pramipexole dihydrochloride tablet, extended release .375 mg (ANDA)
Pramipexole dihydrochloride tablet, extended release .75 mg (ANDA)
Pramipexole dihydrochloride tablet, extended release 1.5 mg (ANDA)
Pramipexole dihydrochloride tablet, extended release 2.25 mg (ANDA)
Pramipexole dihydrochloride tablet, extended release 3 mg (ANDA)
Pramipexole dihydrochloride tablet, extended release 3.75 mg (ANDA)
Pramipexole dihydrochloride tablet, extended release 4.5 mg (ANDA)
|
Ingenus Pharmaceuticals, LLC
|
Pramipexole dihydrochloride
|
D00559
|
Cyproheptadine Hydrochloride syrup 2 mg/5mL (ANDA)
|
Tris Pharma Inc
|
Cyproheptadine Hydrochloride
|
D02234
|
Prochlorperazine Edisylate injection 5 mg/mL (ANDA)
|
Cosette Pharmaceuticals, Inc.
|
Prochlorperazine Edisylate
|
D02609
|
Estradiol and Norethindrone Acetate tablet 1 mg (ANDA)
Estradiol and Norethindrone Acetate tablet .5 mg (ANDA)
|
Ingenus Pharmaceuticals, LLC
|
Estradiol and Norethindrone Acetate
|
D09188
|
Tranylcypromine Sulfate tablet, film coated 10 mg (NDA AUTHORIZED GENERIC)
|
Actavis Pharma, Inc.
|
tranylcypromine sulfate
|
D00826
|
Glyburide and Metformin Hydrochloride tablet, film coated 1.25 mg (ANDA)
Glyburide and Metformin Hydrochloride tablet, film coated 2.5 mg (ANDA)
Glyburide and Metformin Hydrochloride tablet, film coated 5 mg (ANDA)
|
Aurobindo Pharma Limited
|
Glyburide and Metformin Hydrochloride
|
D10266
|
PARNATE tablet, film coated 10 mg (NDA)
|
Concordia Pharmaceuticals Inc.
|
tranylcypromine sulfate
|
D00826
|
Myalept injection, powder, lyophilized, for solution 11.3 mg/2.2mL (BLA)
|
Amryt Pharmaceuticals DAC
|
metreleptin
|
D05014
|
Nystatin cream 100000 [USP'U]/g (ANDA)
|
NuCare Pharmaceuticals,Inc.
|
Nystatin Cream
|
D00202
|
Albuterol Sulfate solution .83 mg/mL (ANDA)
|
NuCare Pharmaceuticals,Inc.
|
albuterol sulfate
|
D00683
|
Testosterone Cypionate injection 200 mg/mL (ANDA)
|
Hikma Pharmaceuticals USA Inc.
|
Testosterone Cypionate
|
D00957
|
Dilantin-125 suspension 125 mg/5mL (NDA)
|
Parke-Davis Div of Pfizer Inc
|
Phenytoin
|
D00512
|
Amlodipine besylate tablet 2.5 mg (ANDA)
Amlodipine besylate tablet 5 mg (ANDA)
Amlodipine besylate tablet 10 mg (ANDA)
|
Exelan Pharmaceuticals, Inc.
|
Amlodipine besylate
|
D00615
|
Sodium Chloride injection 9 mg/mL (NDA)
|
B. Braun Medical Inc.
|
Sodium Chloride
|
D02056
|
Cefprozil tablet, film coated 250 mg (ANDA)
Cefprozil tablet, film coated 500 mg (ANDA)
|
Teva Pharmaceuticals USA, Inc.
|
Cefprozil
|
D00261
|
Montelukast tablet 10 mg (ANDA)
|
BluePoint Laboratories
|
Montelukast
|
D00529
|
Sterile Water injection 1 mL/mL (NDA)
|
B. Braun Medical Inc.
|
Water
|
D00001
|
LUMIGAN solution/ drops .1 mg/mL (NDA)
|
Allergan, Inc.
|
bimatoprost
|
D02724
|
Naloxone Hydrochloride Injection, USP, Auto-Injector injection, solution 10 mg/.4mL (NDA)
|
Kaleo, Inc.
|
Naloxone Hydrochloride
|
D01340
|
Cefadroxil capsule 500 mg (ANDA)
|
Teva Pharmaceuticals USA, Inc.
|
Cefadroxil
|
D02353
|
Ambien tablet, film coated 5 mg (NDA)
Ambien tablet, film coated 10 mg (NDA)
|
sanofi-aventis U.S. LLC
|
zolpidem tartrate
|
D00706
|
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE tablet, film coated 25 mg (ANDA)
|
Direct Rx
|
losartan potassium and hydrochlorothiazide
|
D07895
|
Sodium Chloride injection, solution 3 g00mL (NDA)
Sodium Chloride injection, solution 5 g00mL (NDA)
|
B. Braun Medical Inc.
|
Sodium Chloride
|
D02056
|
Diclofenac Potassium capsule, liquid filled 25 mg (ANDA)
|
Aurobindo Pharma Limited
|
Diclofenac Potassium
|
D00903
|
CARBAMAZEPINE tablet, chewable 100 mg (ANDA)
CARBAMAZEPINE tablet 200 mg (ANDA)
|
Major Pharmaceuticals
|
CARBAMAZEPINE
|
D00252
|
Potassium Chloride capsule, coated, extended release 10 meq (ANDA)
|
Major Pharmaceuticals
|
Potassium Chloride
|
D02060
|
FOSAPREPITANT DIMEGLUMINE injection, powder, lyophilized, for solution 150 mg/5mL (ANDA)
|
Qilu Pharmaceutical Co., Ltd.
|
FOSAPREPITANT DIMEGLUMINE
|
D06597
|
Oxybutynin Chloride tablet, extended release 5 mg (ANDA)
Oxybutynin Chloride tablet, extended release 10 mg (ANDA)
Oxybutynin Chloride tablet, extended release 15 mg (ANDA)
|
Advagen Pharma Limited
|
Oxybutynin Chloride
|
D00722
|
Nateglinide tablet, coated 60 mg (ANDA)
Nateglinide tablet, coated 120 mg (ANDA)
|
Modavar Pharmaceuticals LLC
|
Nateglinide
|
D01111
|
Leucovorin Calcium injection, powder, lyophilized, for solution 200 mg/20mL (ANDA)
Leucovorin Calcium injection, powder, lyophilized, for solution 500 mg/50mL (ANDA)
|
Fresenius Kabi USA, LLC
|
LEUCOVORIN CALCIUM
|
D01211
|
Levora kit (ANDA)
|
Mayne Pharma Inc.
|
levonorgestrel and ethinyl estradiol
|
D04482
|