| Product |
Company |
Generic name |
KEGG DRUG |
|
Acyclovir capsule 200 mg (ANDA)
|
Florida Pharmaceutical Products, LLC |
Acyclovir |
D00222
|
|
Isosulfan Blue injection, solution 50 mg/5mL (ANDA)
|
Eugia US LLC |
Isosulfan Blue |
D04634
|
|
Brivaracetam solution 10 mg/mL (ANDA)
|
PAI Holdings, LLC dba PAI Pharma |
Brivaracetam |
D08879
|
|
Brivaracetam injection 50 mg/5mL (ANDA)
|
PAI Holdings, LLC dba PAI Pharma |
Brivaracetam Injection |
D08879
|
MITIGO injection 200 mg/20mL (ANDA)
MITIGO injection 500 mg/20mL (ANDA)
|
Piramal Critical Care, Inc. |
Morphine Sulfate |
D00842
|
CARVEDILOL tablet, film coated 3.125 mg (ANDA)
CARVEDILOL tablet, film coated 6.25 mg (ANDA)
CARVEDILOL tablet, film coated 12.5 mg (ANDA)
CARVEDILOL tablet, film coated 25 mg (ANDA)
|
Advagen Pharma Ltd |
CARVEDILOL |
D00255
|
|
Mifepristone tablet 200 mg (ANDA)
|
Evita Solutions LLC |
MIFEPRISTONE |
D00585
|
Dicyclomine hydrochloride tablet 20 mg (ANDA)
Dicyclomine hydrochloride tablet 40 mg (ANDA)
|
Advagen Pharma Ltd., |
Dicyclomine hydrochloride |
D00717
|
|
Polymyxin B injection, powder, for solution 500000 [USP'U] (ANDA)
|
Hikma Pharmaceuticals USA Inc. |
Polymyxin B Sulfate |
D01066
|
|
Amoxicillin capsule 500 mg (ANDA)
|
REMEDYREPACK INC. |
Amoxicillin |
D00229
|
Buprenorphine and Naloxone tablet 2 mg (ANDA)
Buprenorphine and Naloxone tablet 8 mg (ANDA)
|
Lannett Company, Inc. |
Buprenorphine and Naloxone |
D10250
|
|
Tranexamic Acid injection, solution 100 mg/mL (ANDA)
|
XGen Pharmaceuticals DJB, Inc. |
Tranexamic Acid |
D01136
|
|
Primaquine Phosphate tablet, film coated 15 mg (NDA)
|
Sanofi-Aventis U.S. LLC |
Primaquine Phosphate |
D02126
|
|
Zoledronic acid injection, solution, concentrate 4 mg/5mL (ANDA)
|
Mylan Institutional LLC |
Zoledronic acid |
D01968
|
|
SEVOFLURANE liquid 250 mL/250mL (ANDA)
|
Baxter Healthcare Corporation |
Sevoflurane |
D00547
|
Labetalol Hydrochloride tablet, film coated 100 mg (ANDA)
Labetalol Hydrochloride tablet, film coated 200 mg (ANDA)
Labetalol Hydrochloride tablet, film coated 300 mg (ANDA)
Labetalol Hydrochloride tablet, film coated 400 mg (ANDA)
|
Biocon Pharma Inc. |
Labetalol Hydrochloride |
D00600
|
BENLYSTA solution 200 mg/mL (BLA)
BENLYSTA injection, powder, lyophilized, for solution 120 mg.5mL (BLA)
BENLYSTA injection, powder, lyophilized, for solution 400 mg/5mL (BLA)
|
GlaxoSmithKline LLC |
belimumab |
D03068
|
|
Buprenorphine and Naloxone film 2 mg (ANDA)
|
Redpharm Drug |
Buprenorphine and Naloxone |
D10250
|
|
Paroxetine tablet, film coated 10 mg (ANDA)
|
A-S Medication Solutions |
Paroxetine |
D02260
|
SUTENT capsule 12.5 mg (NDA)
SUTENT capsule 25 mg (NDA)
SUTENT capsule 37.5 mg (NDA)
SUTENT capsule 50 mg (NDA)
|
Pfizer Laboratories Div Pfizer Inc |
Sunitinib malate |
D06402
|
|
Ibuprofen tablet 600 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC |
Ibuprofen |
D00126
|
|
Spironolactone tablet, coated 25 mg (ANDA)
|
NuCare Pharmaceuticals, Inc. |
Spironolactone |
D00443
|
|
Amiodarone Hydrochloride tablet 200 mg (ANDA)
|
REMEDYREPACK INC. |
Amiodarone Hydrochloride |
D00636
|
|
sumatriptan injection, solution 6 mg/.5mL (ANDA)
|
ONESOURCE SPECIALTY PHARMA LIMITED |
sumatriptan |
D00676
|
|
Amitriptyline Hydrochloride tablet, film coated 10 mg (ANDA)
|
Preferred Pharmaceuticals Inc. |
Amitriptyline Hydrochloride |
D00809
|
brivaracetam tablet, film coated 10 mg (ANDA)
brivaracetam tablet, film coated 25 mg (ANDA)
brivaracetam tablet, film coated 50 mg (ANDA)
brivaracetam tablet, film coated 75 mg (ANDA)
brivaracetam tablet, film coated 100 mg (ANDA)
|
Zydus Lifesciences Limited |
brivaracetam |
D08879
|
buprenorphine hydrochloride and naloxone hydrochloride dihydrate tablet 2 mg (ANDA)
buprenorphine hydrochloride and naloxone hydrochloride dihydrate tablet 8 mg (ANDA)
|
Hikma Pharmaceuticals USA Inc. |
buprenorphine hydrochloride and naloxone hydrochloride dihydrate |
D10250
|
|
Amantadine tablet 100 mg (ANDA)
|
Proficient Rx LP |
Amantadine |
D00777
|
|
Blujepa tablet, film coated 750 mg (NDA)
|
GlaxoSmithKline LLC |
gepotidacin |
D10879
|
Terazosin capsule 2 mg (ANDA)
Terazosin capsule 5 mg (ANDA)
Terazosin capsule 10 mg (ANDA)
|
A-S Medication Solutions |
Terazosin Hydrochloride |
D11585
|
|
vigabatrin tablet, film coated 500 mg (ANDA)
|
Carnegie Pharmaceuticals LLC |
vigabatrin |
D00535
|
|
LEVOTHYROXINE SODIUM tablet 25 ug (ANDA)
|
A-S Medication Solutions |
LEVOTHYROXINE SODIUM |
D01010
|
Diazepam tablet 2 mg (ANDA)
Diazepam tablet 5 mg (ANDA)
Diazepam tablet 10 mg (ANDA)
|
Safecor Health, LLC |
diazepam |
D00293
|
|
PROCHLORPERAZINE MALEATE tablet 10 mg (ANDA)
|
A-S Medication Solutions |
Prochlorperazine maleate |
D00479
|
Buprenorphine and Naloxone tablet 2 mg (ANDA)
Buprenorphine and Naloxone tablet 8 mg (ANDA)
|
Sun Pharmaceutical Industries, Inc. |
Buprenorphine and Naloxone |
D10250
|
|
GIMOTI spray 15 mg/.07mL (NDA)
|
Evoke Pharma, Inc. |
METOCLOPRAMIDE HYDROCHLORIDE |
D05008
|
|
Glipizide tablet 5 mg (ANDA)
|
A-S Medication Solutions |
Glipizide |
D00335
|
Furosemide tablet 20 mg (NDA)
Furosemide tablet 40 mg (NDA)
Furosemide tablet 80 mg (ANDA)
Furosemide solution 40 mg/5mL (ANDA)
Furosemide solution 10 mg/mL (ANDA)
|
Hikma Pharmaceuticals USA Inc. |
Furosemide |
D00331
|
Rybrevant Faspro injection 1600 mg0mL (BLA)
Rybrevant Faspro injection 2240 mg4mL (BLA)
Rybrevant Faspro injection 2400 mg5mL (BLA)
Rybrevant Faspro injection 3520 mg/22mL (BLA)
|
Janssen Biotech, Inc. |
AMIVANTAMAB and HYALURONIDASE-lpuj (HUMAN RECOMBINANT) |
D13229
|
Buprenorphine tablet 2 mg (ANDA)
Buprenorphine tablet 8 mg (ANDA)
|
Sun Pharmaceutical Industries, Inc. |
Buprenorphine |
D00836
|