| Product |
Company |
Generic name |
KEGG DRUG |
|
Sacubitril and Valsartan tablet 97 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC |
Sacubitril and Valsartan |
D10226
|
|
Amantadine HCL capsule 100 mg (ANDA)
|
Direct RX |
Amantadine HCL |
D00777
|
|
Sacubitril and Valsartan tablet 49 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC |
Sacubitril and Valsartan |
D10226
|
|
Butalbital, Acetaminophen, Caffeine tablet 325 mg (ANDA)
|
Advanced Rx of Tennessee, LLC |
Butalbital, Acetaminophen, and Caffeine |
D11850
|
|
Bupropion hydrochloride tablet, extended release 300 mg (ANDA)
|
Coupler LLC |
Bupropion hydrochloride |
D00817
|
|
ARIKAYCE suspension 590 mg/8.4mL (NDA)
|
Insmed Incorporated |
Amikacin |
D00865
|
|
Rosuvastatin tablet, film coated 5 mg (ANDA)
|
A-S Medication Solutions |
Rosuvastatin |
D01915
|
|
ACETAMINOPHEN AND CODEINE PHOSPHATE tablet 300 mg (ANDA)
|
Preferred Pharmaceuticals Inc. |
acetaminophen and codeine phosphate |
D02146
|
|
Acetazolamide injection, powder, for solution 500 mg/5mL (ANDA)
|
Sagent Pharmaceuticals |
Acetazolamide Sodium |
D01196
|
Imipramine Hydrochloride tablet 10 mg (ANDA)
Imipramine Hydrochloride tablet 25 mg (ANDA)
Imipramine Hydrochloride tablet 50 mg (ANDA)
|
Proficient Rx LP |
Imipramine Hydrochloride |
D00815
|
Cardura tablet 1 mg (NDA)
Cardura tablet 2 mg (NDA)
Cardura tablet 4 mg (NDA)
Cardura tablet 8 mg (NDA)
|
Viatris Specialty LLC |
doxazosin |
D00608
|
|
Testosterone gel 16.2 mg/g (ANDA)
|
Lupin Pharmaceuticals, Inc. |
Testosterone |
D00075
|
|
Lamotrigine tablet 100 mg (ANDA)
|
Preferred Pharmaceuticals Inc. |
Lamotrigine |
D00354
|
Omeprazole and Sodium Bicarbonate powder, for suspension 20 mg (ANDA)
Omeprazole and Sodium Bicarbonate powder, for suspension 40 mg (ANDA)
|
ANI Pharmaceuticals, Inc. |
Omeprazole and Sodium Bicarbonate |
D11706
|
METOLAZONE tablet 2.5 mg (ANDA)
METOLAZONE tablet 5 mg (ANDA)
METOLAZONE tablet 10 mg (ANDA)
|
Advagen Pharma Limited |
METOLAZONE |
D00431
|
|
Amlodipine Besylate tablet 10 mg (ANDA)
|
Preferred Pharmaceuticals Inc. |
Amlodipine besylate |
D00615
|
Telmisartan tablet 20 mg (ANDA)
Telmisartan tablet 40 mg (ANDA)
Telmisartan tablet 80 mg (ANDA)
|
AvKARE |
Telmisartan |
D00627
|
|
Lutathera injection 10 mCi/mL (NDA)
|
Advanced Accelerator Applications USA, Inc |
Lutetium Lu 177 dotatate |
D11033
|
|
calcium chloride injection, solution 100 mg/mL (ANDA)
|
SQUARE PHARMACEUTICALS PLC. |
calcium chloride |
D02256
|
|
Potassium Chloride capsule, extended release 750 mg (ANDA)
|
AvKARE |
Potassium Chloride |
D02060
|
|
VIZZ solution/ drops 14.66 mg/mL (NDA)
|
LENZ Therapeutics, Inc. |
Aceclidine |
D13152
|
|
Oseltamivir Phosphate for suspension 6 mg/mL (ANDA)
|
AvKARE |
Oseltamivir Phosphate |
D00900
|
|
ZOLPIDEM TARTRATE tablet 10 mg (ANDA)
|
Calvin Scott & Co., Inc. |
ZOLPIDEM TARTRATE |
D00706
|
|
temazepam capsule 30 mg (ANDA)
|
Preferred Pharmaceuticals Inc. |
temazepam |
D00370
|
|
Tenofovir Disoproxil Fumarate tablet, film coated 300 mg (ANDA)
|
AvKARE |
Tenofovir Disoproxil Fumarate |
D01982
|
Isosorbide Dinitrate tablet 5 mg (ANDA)
Isosorbide Dinitrate tablet 10 mg (ANDA)
Isosorbide Dinitrate tablet 20 mg (ANDA)
|
Golden State Medical Supply, Inc. |
Isosorbide Dinitrate |
D00516
|
Vardenafil Hydrochloride tablet 10 mg (ANDA)
Vardenafil Hydrochloride tablet 20 mg (ANDA)
|
AvKARE |
Vardenafil Hydrochloride |
D03260
|
|
LOCAMETZ injection, powder, lyophilized, for solution 25 ug (NDA)
|
Novartis Pharmaceuticals Corporation |
kit for the preparation of gallium Ga 68 gozetotide |
D12257
|
|
Quetiapine tablet, film coated 25 mg (ANDA)
|
AvKARE |
Quetiapine |
D00458
|
LEFLUNOMIDE tablet 10 mg (ANDA)
LEFLUNOMIDE tablet 20 mg (ANDA)
|
AvKARE |
LEFLUNOMIDE |
D00749
|
Glimepiride tablet 1 mg (ANDA)
Glimepiride tablet 2 mg (ANDA)
Glimepiride tablet 4 mg (ANDA)
|
AvPAK |
Glimepiride |
D00593
|
|
Clopidogrel tablet, film coated 300 mg (ANDA)
|
AvPAK |
Clopidogrel Bisulfate |
D00769
|
Oxybutynin Chloride tablet, extended release 5 mg (ANDA)
Oxybutynin Chloride tablet, extended release 10 mg (ANDA)
Oxybutynin Chloride tablet, extended release 15 mg (ANDA)
|
Ajanta Pharma USA Inc. |
Oxybutynin Chloride |
D00722
|
Zokinvy capsule 50 mg (NDA)
Zokinvy capsule 75 mg (NDA)
|
Sentynl Therapeutics, Inc. |
lonafarnib |
D04768
|
|
Ibandronate Sodium injection 3 mg/3mL (ANDA)
|
Apotex Corp. |
ibandronate sodium |
D04486
|
|
Pentazocine and naloxone tablet .5 mg (ANDA)
|
Actavis Pharma, Inc. |
Pentazocine hydrochloride and naloxone hydrochloride |
D12492
|
|
Rosuvastatin tablet, film coated 5 mg (ANDA)
|
A-S Medication Solutions |
Rosuvastatin |
D01915
|
|
Furosemide injection, solution 10 mg/mL (ANDA)
|
Meitheal Pharmaceuticals Inc. |
Furosemide |
D00331
|
VERAPAMIL HYDROCHLORIDE tablet 40 mg (ANDA)
VERAPAMIL HYDROCHLORIDE tablet 80 mg (ANDA)
VERAPAMIL HYDROCHLORIDE tablet 120 mg (ANDA)
|
AvKARE |
VERAPAMIL HYDROCHLORIDE |
D00619
|
|
Trazodone Hydrochloride tablet 150 mg (ANDA)
|
AvKARE |
Trazodone Hydrochloride |
D00820
|