| Product |
Company |
Generic name |
KEGG DRUG |
|
Tranexamic Acid injection, solution 100 mg/mL (ANDA)
|
Sagent Pharmaceuticals
|
Tranexamic Acid
|
D01136
|
Vancomycin injection, powder, lyophilized, for solution 5 g00mL (ANDA)
Vancomycin injection, powder, lyophilized, for solution 10 g00mL (ANDA)
|
Sagent Pharmaceuticals
|
vancomycin hydrochloride
|
D00926
|
Vancomycin Hydrochloride injection, powder, lyophilized, for solution 500 mg0mL (ANDA)
Vancomycin Hydrochloride injection, powder, lyophilized, for solution 1 g/20mL (ANDA)
|
Sagent Pharmaceuticals
|
vancomycin hydrochloride
|
D00926
|
|
Travoprost Ophthalmic Soluton solution/ drops .04 mg/mL (ANDA)
|
Sagent Pharmaceuticals
|
Travoprost
|
D01964
|
|
Insulin Glargine-aldy injection, solution 100 [iU]/mL (BLA)
|
Lanexa Biologics, LLC
|
insulin glargine-aldy
|
D03250
|
PITOLISANT tablet, film coated 4.45 mg (ANDA)
PITOLISANT tablet, film coated 17.8 mg (ANDA)
|
Lupin Pharmaceuticals, Inc.
|
pitolisant
|
D11490
|
|
Tranexamic Acid injection, solution 10 mg/mL (ANDA)
|
Sagent Pharmaceuticals
|
Tranexamic Acid
|
D01136
|
|
ganciclovir injection, solution 50 mg/mL (ANDA)
|
Sagent Pharmaceuticals
|
ganciclovir sodium
|
D04301
|
|
Tranexamic Acid injection, solution 100 mg/mL (ANDA)
|
Sagent Pharmaceuticals
|
Tranexamic Acid
|
D01136
|
|
Metronidazole injection, solution 500 mg00mL (ANDA)
|
Sagent Pharmaceuticals
|
Metronidazole
|
D00409
|
Phenylephrine hydrochloride injection 10 mg/mL (ANDA)
Phenylephrine hydrochloride injection 50 mg/5mL (ANDA)
Phenylephrine hydrochloride injection 100 mg0mL (ANDA)
|
Lifestar Pharma LLC
|
phenylephrine hydrochloride
|
D00511
|
Rubraca tablet, film coated 200 mg (NDA)
Rubraca tablet, film coated 250 mg (NDA)
Rubraca tablet, film coated 300 mg (NDA)
|
pharmaand GmbH
|
rucaparib
|
D10982
|
|
Tazarotene cream 1 mg/g (ANDA)
|
Mayne Pharma
|
TAZAROTENE
|
D01132
|
|
Lithium Carbonate tablet, extended release 300 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc.
|
Lithium Carbonate
|
D00801
|
|
Lorazepam tablet 2 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc.
|
Lorazepam
|
D00365
|
|
Orgovyx tablet, film coated 120 mg (NDA)
|
Sumitomo Pharma America, Inc.
|
relugolix
|
D10888
|
Linzess capsule, gelatin coated 145 ug (NDA)
Linzess capsule, gelatin coated 290 ug (NDA)
Linzess capsule, gelatin coated 72 ug (NDA)
|
Allergan, Inc.
|
linaclotide
|
D09355
|
|
METFORMIN HYDROCHLORIDE tablet, extended release 1000 mg (ANDA)
|
REMEDYREPACK INC.
|
Metformin Hydrochloride
|
D00944
|
|
Carbon Dioxide Oxygen gas 800 mL/L (NDA)
|
MATHESON TRI-GAS, INC.
|
Carbon Dioxide Oxygen
|
D03043
|
|
Carbon Dioxide/Oxygen 5/95 gas 950 mL/L (NDA)
|
MATHESON TRI-GAS, INC.
|
Carbon Dioxide/Oxygen 5/95
|
|
|
Oxygen/Helium 20/80 gas 200 mL/L (NDA)
|
MATHESON TRI-GAS, INC.
|
Oxygen/Helium 20/80
|
|
|
Oxygen/Helium 25/75 gas 250 mL/L (NDA)
|
MATHESON TRI-GAS, INC.
|
Oxygen/Helium 25/75
|
|
|
Oxygen/Helium 40/60 gas 400 mL/L (NDA)
|
MATHESON TRI-GAS, INC.
|
Oxygen/Helium 40/60
|
|
|
Oxygen/Helium 50/50 gas 500 mL/L (NDA)
|
MATHESON TRI-GAS, INC.
|
Oxygen/Helium 50/50
|
|
|
Oxygen/Helium 30/70 gas 300 mL/L (NDA)
|
MATHESON TRI-GAS, INC.
|
Oxygen/Helium 30/70
|
|
|
Carbon Dioxide gas 992 mL/L (NDA)
|
Matheson Tri-Gas, Inc.
|
Carbon Dioxide
|
D00004
|
|
Helium gas 992 mL/L (NDA)
|
Matheson Tri-Gas, Inc.
|
Helium
|
D04420
|
Gabapentin capsule 100 mg (ANDA)
Gabapentin capsule 300 mg (ANDA)
Gabapentin capsule 400 mg (ANDA)
|
ScieGen Pharmaceuticals, Inc.
|
Gabapentin
|
D00332
|
|
Lithium Carbonate capsule, gelatin coated 600 mg (NDA)
|
PD-Rx Pharmaceuticals, Inc.
|
Lithium Carbonate
|
D00801
|
|
Tizanidine tablet 4 mg (ANDA)
|
REMEDYREPACK INC.
|
Tizanidine
|
D00776
|
|
Oxytocin injection, solution 10 [USP'U]/mL (NDA)
|
Cardinal Health 107, LLC
|
OXYTOCIN
|
D00089
|
Prednisone tablet 5 mg (ANDA)
Prednisone tablet 20 mg (ANDA)
|
Cardinal Health 107, LLC
|
Prednisone
|
D00473
|
|
Metaxalone tablet 800 mg (ANDA)
|
Proficient Rx LP
|
Metaxalone
|
D00773
|
|
NEREUS capsule 85 mg (NDA)
|
Vanda Pharmaceuticals Inc.
|
TRADIPITANT
|
D11728
|
Lorazepam tablet 2 mg (ANDA)
Lorazepam tablet .5 mg (ANDA)
Lorazepam tablet 1 mg (ANDA)
|
Teva Pharmaceuticals USA, Inc.
|
Lorazepam
|
D00365
|
|
Amoxicillin and Clavulanate Potassium tablet, film coated 875 mg (ANDA)
|
Proficient Rx LP
|
Amoxicillin and Clavulanate Potassium
|
D06485
|
|
Metformin HCl tablet 1000 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc.
|
Metformin HCl
|
D00944
|
ustekinumab injection, solution 45 mg/.5mL (BLA)
ustekinumab injection, solution 90 mg/mL (BLA)
ustekinumab solution 130 mg/26mL (BLA)
|
Janssen Biotech, Inc.
|
ustekinumab
|
D09214
|
|
Nayzilam spray 5 mg/.1mL (NDA)
|
UCB, Inc.
|
midazolam
|
D00550
|
Hydralazine Hydrochloride tablet 25 mg (ANDA)
Hydralazine Hydrochloride tablet 50 mg (ANDA)
|
Cardinal Health 107, LLC
|
Hydralazine Hydrochloride
|
D01302
|