| Product |
Company |
Generic name |
KEGG DRUG |
Vivelle-Dot patch, extended release .025 mg/d (NDA)
Vivelle-Dot patch, extended release .0375 mg/d (NDA)
Vivelle-Dot patch, extended release .05 mg/d (NDA)
Vivelle-Dot patch, extended release .075 mg/d (NDA)
Vivelle-Dot patch, extended release .1 mg/d (NDA)
|
Sandoz Inc |
estradiol |
D00105
|
|
Medical Oxygen Compressed gas 1 L/L (NDA)
|
MMC - Dickinson Home Medical Equipment |
OXYGEN |
D00003
|
|
SEVELAMER CARBONATE tablet 800 mg (ANDA)
|
Strides Pharma Science Limited |
sevelamer carbonate |
D06642
|
Sumatriptan spray 5 mg/.1mL (ANDA)
Sumatriptan spray 20 mg/.1mL (ANDA)
|
Lannett Company, Inc. |
Sumatriptan |
D00451
|
|
OXYCODONE HYDROCHLORIDE solution 5 mg/5mL (ANDA)
|
PAI Holdings, LLC dba PAI Pharma |
OXYCODONE HYDROCHLORIDE |
D00847
|
Memantine Hydrochloride tablet 5 mg (ANDA)
Memantine Hydrochloride tablet 10 mg (ANDA)
|
Lannett Company, Inc. |
Memantine Hydrochloride |
D04905
|
|
DOXYCYCLINE capsule 40 mg (ANDA)
|
Alembic Pharmaceuticals Limited |
DOXYCYCLINE |
D00307
|
|
Ibuprofen tablet, film coated 600 mg (ANDA)
|
NuCare Pharmaceuticals,Inc. |
Ibuprofen |
D00126
|
|
Amoxicillin capsule 500 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc. |
Amoxicillin |
D00229
|
|
HYDROCODONE BITARTRATE AND ACETAMINOPHEN tablet 325 mg (ANDA)
|
Proficient Rx LP |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
D00846
|
Primidone tablet 50 mg (ANDA)
Primidone tablet 250 mg (ANDA)
|
Lannett Company, Inc. |
Primidone |
D00474
|
|
Xofigo injection 30 uCi/mL (NDA)
|
Bayer HealthCare Pharmaceuticals Inc. |
Radium Ra 223 dichloride |
D10398
|
|
Besivance suspension 6 mg/mL (NDA)
|
Bausch & Lomb Incorporated |
Besifloxacin |
D08872
|
|
SERTRALINE HYDROCHLORIDE tablet, film coated 50 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc. |
SERTRALINE HYDROCHLORIDE |
D00825
|
|
Probenecid tablet, film coated 500 mg (ANDA)
|
Lannett Company, Inc. |
Probenecid |
D00475
|
Dicyclomine Hydrochloride tablet 20 mg (ANDA)
Dicyclomine Hydrochloride capsule 10 mg (ANDA)
|
Lannett Company, Inc. |
Dicyclomine Hydrochloride |
D00717
|
|
Tobramycin injection, powder, lyophilized, for solution 1.2 g/30mL (ANDA)
|
Fosun Pharma USA Inc |
Tobramycin |
D02542
|
Amoxicillin powder, for suspension 200 mg/5mL (ANDA)
Amoxicillin powder, for suspension 400 mg/5mL (ANDA)
|
Hikma Pharmaceuticals USA Inc. |
Amoxicillin |
D00229
|
|
Diethylpropion Hydrochloride ER tablet, extended release 75 mg (ANDA)
|
Lannett Company, Inc. |
Diethylpropion Hydrochloride |
D03801
|
Primidone tablet 50 mg (ANDA)
Primidone tablet 250 mg (ANDA)
|
Carnegie Pharmaceuticals LLC |
Primidone |
D00474
|
risedronate sodium tablet, film coated 75 mg (ANDA)
risedronate sodium tablet, film coated 150 mg (ANDA)
risedronate sodium tablet, film coated 5 mg (ANDA)
risedronate sodium tablet, film coated 30 mg (ANDA)
risedronate sodium tablet, film coated 35 mg (ANDA)
|
Sun Pharmaceutical Industries, Inc. |
risedronate sodium |
D03234
|
|
Venlafaxine Hydrochloride capsule, extended release 75 mg (ANDA)
|
Bryant Ranch Prepack |
VENLAFAXINE HYDROCHLORIDE |
D00821
|
|
Metoprolol Tartrate tablet, film coated 100 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc. |
Metoprolol Tartrate |
D00601
|
OXYBUTYNIN CHLORIDE tablet 5 mg (ANDA)
OXYBUTYNIN CHLORIDE tablet 2.5 mg (ANDA)
|
RISING PHARMA HOLDINGS, INC. |
OXYBUTYNIN CHLORIDE |
D00722
|
Terbutaline Sulfate tablet 5 mg (ANDA)
Terbutaline Sulfate tablet 2.5 mg (ANDA)
|
Lannett Company, Inc. |
Terbutaline Sulfate |
D00688
|
|
Carvedilol tablet, film coated 6.25 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc. |
Carvedilol |
D00255
|
|
Glimepiride tablet 2 mg (ANDA)
|
NuCare Pharmaceuticals,Inc. |
Glimepiride |
D00593
|
|
Methocarbamol tablet 500 mg (ANDA)
|
NuCare Pharmaceuticals, Inc. |
methocarbamol |
D00402
|
|
Metformin Hydrochloride tablet, film coated, extended release 1000 mg (ANDA)
|
Golden State Medical Supply, Inc. |
metformin hydrochloride |
D00944
|
|
Baclofen suspension 5 mg/mL (NDA AUTHORIZED GENERIC)
|
Bryant Ranch Prepack |
baclofen |
D00241
|
Imatinib Mesylate tablet, film coated 100 mg (ANDA)
Imatinib Mesylate tablet, film coated 400 mg (ANDA)
|
Golden State Medical Supply, Inc. |
imatinib |
D01441
|
|
Sertraline Hydrochloride solution, concentrate 20 mg/mL (ANDA)
|
Rising Pharma Holdings, Inc. |
Sertraline Hydrochloride |
D00825
|
|
Spironolactone tablet, film coated 100 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc. |
spironolactone |
D00443
|
|
Spironolactone tablet, film coated 25 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc. |
spironolactone |
D00443
|
|
Amoxicillin capsule 500 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc. |
Amoxicillin |
D00229
|
Febuxostat tablet, film coated 40 mg (ANDA)
Febuxostat tablet, film coated 80 mg (ANDA)
|
MAJOR PHARMACEUTICALS |
Febuxostat |
D01206
|
|
Hydroxyzine hydrochloride tablet 25 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC |
Hydroxyzine hydrochloride |
D00672
|
DEXTROAMPHETAMINE SULFATE tablet 5 mg (ANDA)
DEXTROAMPHETAMINE SULFATE tablet 10 mg (ANDA)
|
Aurolife Pharma, LLC |
DEXTROAMPHETAMINE SULFATE |
D02078
|
|
OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE tablet 12.5 mg (ANDA)
|
Bryant Ranch Prepack |
olmesartan medoxomil and hydrochlorothiazide |
D10284
|
|
Albendazole tablet 200 mg (ANDA)
|
Bryant Ranch Prepack |
Albendazole |
D00134
|