| Product |
Company |
Generic name |
KEGG DRUG |
|
gadoterate meglumine injection 376.9 mg/mL (ANDA)
|
Slate Run Pharmaceuticals, LLC |
gadoterate meglumine |
D03355
|
LOSARTAN POTASSIUM tablet, film coated 25 mg (ANDA)
LOSARTAN POTASSIUM tablet, film coated 50 mg (ANDA)
LOSARTAN POTASSIUM tablet, film coated 100 mg (ANDA)
|
Hisun Pharmaceuticals USA, Inc. |
LOSARTAN POTASSIUM |
D00357
|
|
gadoterate meglumine injection 376.9 mg/mL (ANDA)
|
Slate Run Pharmaceuticals, LLC |
gadoterate meglumine |
D03355
|
|
vancomycin hydrochloride capsule 250 mg (NDA AUTHORIZED GENERIC)
|
Advanced Rx of Tennessee, LLC |
vancomycin hydrochloride |
D00926
|
|
Emtricitabine and tenofovir disoproxil fumarate tablet, film coated 200 mg (ANDA)
|
NuCare Pharmaceuticals, Inc. |
Emtricitabine and tenofovir disoproxil fumarate |
D02297
|
|
Sildenafil tablet, film coated 100 mg (ANDA)
|
NuCare Pharmaceuticals, Inc. |
Sildenafil |
D02229
|
|
Metformin Hydrochloride tablet, film coated 850 mg (ANDA)
|
NuCare Pharmaceuticals,Inc. |
Metformin Hydrochloride |
D00944
|
|
DEXTENZA insert .4 mg (NDA)
|
Ocular Therapeutix, Inc. |
dexamethasone |
D00292
|
Lidocaine Hydrochloride injection, solution 10 mg/mL (ANDA)
Lidocaine Hydrochloride injection, solution 20 mg/mL (ANDA)
|
Eugia US LLC |
Lidocaine Hydrochloride |
D02086
|
Potassium Chloride solution 20 meq5mL (ANDA)
Potassium Chloride solution 40 meq5mL (ANDA)
|
BPI Labs LLC |
Potassium Chloride |
D02060
|
|
LIKMEZ suspension 100 mg/mL (NDA)
|
Saptalis Pharmaceuticals, LLC |
Metronidazole Oral |
D00409
|
|
Cytarabine injection, solution 100 mg/mL (ANDA)
|
Hospira, Inc. |
CYTARABINE |
D00168
|
Levothyroxine Sodium injection, solution 20 ug/mL (NDA)
Levothyroxine Sodium injection, solution 40 ug/mL (NDA)
Levothyroxine Sodium injection, solution 100 ug/mL (NDA)
|
Fresenius Kabi USA, LLC |
Levothyroxine Sodium |
D11113
|
|
Calcitriol solution 1 ug/mL (ANDA)
|
Rising Pharma Holdings, Inc. |
Calcitriol |
D00129
|
|
LIDOCAINE HYDROCHLORIDE injection, solution 20 mg/mL (ANDA)
|
HF Acquisition Co LLC, DBA HealthFirst |
LIDOCAINE HYDROCHLORIDE |
D08127
|
Benzonatate capsule 100 mg (ANDA)
Benzonatate capsule 200 mg (ANDA)
|
Asclemed USA, Inc. |
Benzonatate |
D00242
|
|
Albuterol Sulfate solution 2.5 mg/.5mL (ANDA)
|
Rising Pharma Holdings, Inc. |
Albuterol Sulfate |
D00683
|
Albuterol Sulfate solution .63 mg/3mL (ANDA)
Albuterol Sulfate solution 1.25 mg/3mL (ANDA)
|
Rising Pharma Holdings, Inc |
Albuterol Sulfate |
D00683
|
|
DIAZEPAM tablet 10 mg (ANDA)
|
Advanced Rx of Tennessee, LLC |
DIAZEPAM |
D00293
|
|
Ticagrelor tablet 90 mg (ANDA)
|
Oryza Pharmaceuticals, Inc. |
Ticagrelor |
D09017
|
|
Zolpidem Tartrate tablet, coated 5 mg (ANDA)
|
Advanced Rx of Tennessee, LLC |
Zolpidem Tartrate |
D00706
|
|
Atenolol tablet 50 mg (ANDA)
|
NuCare Pharmaceuticals,Inc. |
Atenolol |
D00235
|
|
Formoterol fumarate solution 20 ug/2mL (ANDA)
|
Lifestar Pharma LLC |
Formoterol fumarate dihydrate |
D05277
|
|
Apretude kit (NDA)
|
ViiV Healthcare Company |
Cabotegravir |
D10548
|
|
Evenity injection, solution 105 mg.17mL (BLA)
|
Amgen Inc |
romosozumab-aqqg |
D10156
|
prazosin hydrochloride capsule 1 mg (ANDA)
prazosin hydrochloride capsule 2 mg (ANDA)
prazosin hydrochloride capsule 5 mg (ANDA)
|
Novadoz Pharmaceuticals LLC |
prazosin hydrochloride |
D00609
|
|
gadobutrol injection 604.72 mg/mL (ANDA)
|
Slate Run Pharmaceuticals, LLC |
gadobutrol |
D07420
|
|
gadobutrol injection 604.72 mg/mL (ANDA)
|
Slate Run Pharmaceuticals, LLC |
gadobutrol |
D07420
|
Fenofibrate tablet, film coated 54 mg (ANDA)
Fenofibrate tablet, film coated 160 mg (ANDA)
|
American Health Packaging |
Fenofibrate |
D00565
|
topiramate tablet, film coated 25 mg (ANDA)
topiramate tablet, film coated 50 mg (ANDA)
topiramate tablet, film coated 100 mg (ANDA)
topiramate tablet, film coated 200 mg (ANDA)
|
Zydus Pharmaceuticals USA Inc. |
topiramate |
D00537
|
|
TEZRULY solution 1 mg/mL (NDA)
|
ANI Pharmaceuticals, Inc. |
Terazosin |
D00610
|
SIVEXTRO tablet, film coated 200 mg (NDA)
SIVEXTRO injection, powder, lyophilized, for solution 200 mg/4mL (NDA)
|
Merck Sharp & Dohme LLC |
tedizolid phosphate |
D09686
|
|
GABAPENTIN tablet 600 mg (ANDA)
|
Proficient Rx LP |
Gabapentin |
D00332
|
SUNITINIB MALATE capsule 12.5 mg (ANDA)
SUNITINIB MALATE capsule 25 mg (ANDA)
SUNITINIB MALATE capsule 37.5 mg (ANDA)
SUNITINIB MALATE capsule 50 mg (ANDA)
|
Aurobindo Pharma Limited |
SUNITINIB MALATE |
D06402
|
|
gadobutrol injection 604.72 mg/mL (ANDA)
|
Slate Run Pharmaceuticals, LLC |
gadobutrol |
D07420
|
|
Calcium Acetate capsule 667 mg (ANDA)
|
Hikma Pharmaceuticals USA Inc. |
Calcium Acetate |
D00931
|
|
Penicillin V Potassium tablet, film coated 250 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc. |
Penicillin V Potassium |
D00497
|
|
GLYCOPYRROLATE liquid 1 mg/5mL (ANDA)
|
Novadoz Pharmaceuticals LLC |
GLYCOPYRROLATE |
D00540
|
|
Dextrose and Sodium Chloride injection, solution 5 g00mL (ANDA)
|
Fresenius Kabi USA, LLC |
DEXTROSE MONOHYDRATE and SODIUM CHLORIDE |
|
HERZUMA injection, powder, lyophilized, for solution 150 mg/7.15mL (BLA)
HERZUMA kit (BLA)
|
Cephalon, Inc. |
TRASTUZUMAB |
D03257
|