| Product |
Company |
Generic name |
KEGG DRUG |
|
Pentam 300 injection, powder, lyophilized, for solution 300 mg/3mL (NDA)
|
Fresenius Kabi USA, LLC |
PENTAMIDINE ISETHIONATE |
D00834
|
|
Lovastatin tablet 20 mg (ANDA)
|
Proficient Rx LP |
Lovastatin |
D00359
|
|
Doxycycline Hyclate tablet, film coated 100 mg (ANDA)
|
Proficient Rx LP |
Doxycycline Hyclate |
D02129
|
Clonidine hydrochloride tablet .1 mg (ANDA)
Clonidine hydrochloride tablet .2 mg (ANDA)
Clonidine hydrochloride tablet .3 mg (ANDA)
|
Asclemed USA, Inc. |
Clonidine hydrochloride |
D00604
|
|
LAMIVUDINE and ZIDOVUDINE tablet, film coated 150 mg (ANDA)
|
Camber Pharmaceuticals, Inc. |
LAMIVUDINE and ZIDOVUDINE |
D07507
|
captopril tablet 12.5 mg (ANDA)
captopril tablet 25 mg (ANDA)
captopril tablet 50 mg (ANDA)
captopril tablet 100 mg (ANDA)
|
AMICI PHARMACEUTICALS LLC |
captopril |
D00251
|
Timoptic solution 2.5 mg/mL (NDA)
Timoptic solution 5 mg/mL (NDA)
|
Bausch & Lomb Incorporated |
Timolol Maleate |
D00603
|
|
Griseofulvin tablet 500 mg (ANDA)
|
Sigmapharm Laboratories, LLC |
Griseofulvin |
D00209
|
|
valganciclovir hydrochloride for solution 50 mg/mL (ANDA)
|
Novadoz Pharmaceuticals LLC |
valganciclovir hydrochloride |
D03256
|
Febuxostat tablet, film coated 40 mg (ANDA)
Febuxostat tablet, film coated 80 mg (ANDA)
|
Ascend Laboratories, LLC |
Febuxostat |
D01206
|
|
Doxepin hydrochloride capsule 10 mg (ANDA)
|
Proficient Rx LP |
Doxepin hydrochloride |
D00814
|
|
Pryidostigmine Bromide solution 60 mg/5mL (ANDA)
|
Rising Pharma Holdings, Inc. |
Pyridostigmine Bromide |
D00487
|
|
Zylet suspension/ drops 5 mg/mL (NDA)
|
Bausch & Lomb Incorporated |
loteprednol etabonate and tobramycin |
D12133
|
MITOMYCIN injection, powder, lyophilized, for solution 5 mg0mL (ANDA)
MITOMYCIN injection, powder, lyophilized, for solution 20 mg/40mL (ANDA)
|
Meitheal Pharmaceuticals Inc. |
MITOMYCIN |
D00208
|
Nesacaine injection, solution 10 mg/mL (NDA)
Nesacaine injection, solution 20 mg/mL (NDA)
Nesacaine MPF injection, solution 20 mg/mL (NDA)
Nesacaine MPF injection, solution 30 mg/mL (NDA)
|
Fresenius Kabi USA, LLC |
CHLOROPROCAINE HYDROCHLORIDE |
D00732
|
|
Acyclovir suspension 200 mg/5mL (ANDA)
|
Camber Pharmaceuticals, Inc. |
Acyclovir |
D00222
|
|
Tri-Lo-Mili kit (ANDA)
|
Aurobindo Pharma Limited |
Norgestimate and Ethinyl Estradiol |
D10590
|
|
Pantoprazole Sodium tablet, delayed release 40 mg (ANDA)
|
AvPAK |
Pantoprazole Sodium |
D02593
|
|
Desmopressin Acetate injection, solution 4 ug/mL (ANDA)
|
Dr. Reddy's Laboratories Inc. |
Desmopressin Acetate |
D02235
|
Wixela Inhub powder 100 ug (ANDA)
Wixela Inhub powder 250 ug (ANDA)
Wixela Inhub powder 500 ug (ANDA)
|
Mylan Pharmaceuticals Inc. |
fluticasone propionate and salmeterol |
D08699
|
Topiramate tablet 50 mg (ANDA)
Topiramate tablet 25 mg (ANDA)
Topiramate tablet 100 mg (ANDA)
Topiramate tablet 200 mg (ANDA)
|
Asclemed USA, Inc. |
Topiramate |
D00537
|
Atropine Sulfate injection, solution 1 mg/mL (ANDA)
Atropine Sulfate injection, solution .4 mg/mL (ANDA)
|
American Regent, Inc. |
ATROPINE SULFATE |
D02069
|
|
Cefdinir powder, for suspension 250 mg/5mL (ANDA)
|
Proficient Rx LP |
Cefdinir |
D00917
|
|
Tamoxifen Citrate tablet 20 mg (ANDA)
|
Proficient Rx LP |
Tamoxifen Citrate |
D00966
|
|
Diclofenac sodium gel 30 mg/g (ANDA)
|
Asclemed USA, Inc. |
diclofenac sodium |
D00904
|
|
Butalbital, Acetaminophen, Caffeine tablet 325 mg (ANDA)
|
Westminster Pharmaceuticals, LLC |
Butalbital, Acetaminophen, and Caffeine |
D11850
|
|
Nylia 1/35 kit (ANDA)
|
Aurobindo Pharma Limited |
Norethindrone and Ethinyl Estradiol |
D04483
|
|
MITOMYCIN injection, powder, lyophilized, for solution 40 mg/80mL (ANDA)
|
Meitheal Pharmaceuticals Inc. |
MITOMYCIN |
D00208
|
|
Baclofen tablet 10 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC |
Baclofen |
D00241
|
Pioglitazone tablet 15 mg (ANDA)
Pioglitazone tablet 30 mg (ANDA)
Pioglitazone tablet 45 mg (ANDA)
|
NorthStar RxLLC |
Pioglitazone |
D00945
|
Effient tablet, coated 5 mg (NDA)
Effient tablet, coated 10 mg (NDA)
|
Cosette Pharmaceuticals, Inc. |
Prasugrel Hydrochloride |
D05597
|
|
Tretinoin gel .5 mg/g (ANDA)
|
Mylan Pharmaceuticals Inc. |
Tretinoin |
D00094
|
|
Evoxac capsule 30 mg (NDA)
|
Cosette Pharmaceuticals, Inc. |
cevimeline hydrochloride |
D00661
|
Tolvaptan tablet 30 mg (ANDA)
Tolvaptan tablet 60 mg (ANDA)
Tolvaptan tablet 15 mg (ANDA)
|
Ascend Laboratories, LLC |
Tolvaptan |
D01213
|
|
CIPRO HC suspension/ drops 2 mg/mL (NDA)
|
Asclemed USA, Inc. |
ciprofloxacin hydrochloride and hydrocortisone |
D11582
|
Claravis capsule, liquid filled 10 mg (ANDA)
Claravis capsule, liquid filled 20 mg (ANDA)
Claravis capsule, liquid filled 30 mg (ANDA)
Claravis capsule, liquid filled 40 mg (ANDA)
|
Teva Pharmaceuticals USA, Inc. |
Isotretinoin |
D00348
|
Cyclobenzaprine Hydrochloride tablet, film coated 7.5 mg (ANDA)
Cyclobenzaprine Hydrochloride tablet, film coated 5 mg (ANDA)
Cyclobenzaprine Hydrochloride tablet, film coated 10 mg (ANDA)
|
Asclemed USA, Inc. |
Cyclobenzaprine Hydrochloride |
D00772
|
Tolvaptan tablet 30 mg (ANDA)
Tolvaptan tablet 15 mg (ANDA)
|
Camber Pharmaceuticals, Inc. |
Tolvaptan |
D01213
|
|
Paroxetine tablet, film coated 10 mg (ANDA)
|
NCS HealthCare of KY, LLC dba Vangard Labs |
Paroxetine |
D02260
|
|
Mirtazapine tablet, film coated 15 mg (ANDA)
|
Proficient Rx LP |
Mirtazapine |
D00563
|