| Product |
Company |
Generic name |
KEGG DRUG |
|
Oxygen gas 990 mL/L (NDA)
|
Mississippi Welders Supply Company, Inc. |
Oxygen |
D00003
|
|
Nitrogen gas 990 mL/L (NDA)
|
Oxarc, LLC |
Nitrogen |
D00083
|
Ativan tablet .5 mg (NDA)
Ativan tablet 1 mg (NDA)
Ativan tablet 2 mg (NDA)
|
Bausch Health US LLC |
lorazepam |
D00365
|
|
Oxygen gas 992 mL/L (NDA)
|
S. J. Smith Co., Inc. |
Oxygen |
D00003
|
|
Carbon Dioxide gas 990 mL/L (NDA)
|
Oxarc, LLC |
Carbon Dioxide |
D00004
|
IGALMI film 120 ug (NDA)
IGALMI film 180 ug (NDA)
|
BioXcel Therapeutics, Inc. |
DEXMEDETOMIDINE |
D01205
|
|
Pyridostigmine Bromide solution 60 mg/5mL (ANDA)
|
VistaPharm, LLC |
Pyridostigmine Bromide |
D00487
|
|
Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide syrup 2 mg/5mL (ANDA)
|
Chartwell Governmental & Specialty RX, LLC |
Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide |
D11647
|
|
ACD-A solution 24.5 g000mL (NDA)
|
Fenwal, Inc. |
Anticoagulant Citrate Dextrose Solution Formula A |
D02953
|
Kuvan tablet 100 mg (NDA)
Kuvan powder, for solution 100 mg (NDA)
Kuvan powder, for solution 500 mg (NDA)
|
BioMarin Pharmaceutical Inc. |
SAPROPTERIN DIHYDROCHLORIDE |
D01798
|
|
budesonide aerosol, foam 2 mg (NDA)
|
Oceanside Pharmaceuticals |
budesonide |
D00246
|
|
Nitrogen gas 990 mL/L (NDA)
|
Dale Oxygen And Acetylene Service, Inc |
Nitrogen |
D00083
|
|
Clindamycin Phosphate gel 10 mg/g (ANDA)
|
A-S Medication Solutions |
Clindamycin Phosphate |
D01073
|
|
Carbon Dioxide gas 995 mL/L (NDA)
|
MEDICAL-TECHNICAL GASES, INC. |
Carbon Dioxide |
D00004
|
|
Nitrous Oxide gas 995 mL/L (NDA)
|
MEDICAL-TECHNICAL GASES, INC. |
Nitrous Oxide |
D00102
|
|
Nitrogen gas 990 mL/L (NDA)
|
S. J. Smith Co., Inc. |
Nitrogen |
D00083
|
|
Desoximetasone cream .5 mg/g (ANDA)
|
Lupin Pharmaceuticals, Inc. |
Desoximetasone |
D03697
|
|
SOTALOL HYDROCHLORIDE tablet 160 mg (ANDA)
|
Bryant Ranch Prepack |
SOTALOL HYDROCHLORIDE |
D01026
|
Tyvaso DPI kit (NDA)
Tyvaso DPI inhalant 16 ug (NDA)
Tyvaso DPI inhalant 32 ug (NDA)
Tyvaso DPI inhalant 48 ug (NDA)
Tyvaso DPI inhalant 64 ug (NDA)
Tyvaso DPI inhalant 80 ug (NDA)
|
United Therapeutics Corporation |
treprostinil |
D06213
|
LUCENTIS injection, solution 10 mg/mL (BLA)
LUCENTIS injection, solution 6 mg/mL (BLA)
|
Genentech, Inc. |
RANIBIZUMAB |
D05697
|
|
Duloxetine capsule, delayed release 30 mg (ANDA)
|
A-S Medication Solutions |
Duloxetine |
D01179
|
|
Phenylephrine hydrochloride injection 10 mg/mL (ANDA)
|
Provepharm Inc. |
Phenylephrine hydrochloride |
D00511
|
|
Duloxetine capsule, delayed release 30 mg (ANDA)
|
A-S Medication Solutions |
Duloxetine |
D01179
|
IMATINIB MESYLATE tablet, film coated 100 mg (ANDA)
IMATINIB MESYLATE tablet, film coated 400 mg (ANDA)
|
Camber Pharmaceuticals, Inc. |
IMATINIB MESYLATE |
D01441
|
|
Lupron Depot-PED kit (NDA)
|
AbbVie Inc. |
leuprolide acetate |
D00989
|
|
Oxygen gas 990 mL/L (NDA)
|
MEDICAL-TECHNICAL GASES, INC. |
Oxygen |
D00003
|
|
NITROGEN gas 990 mL/L (NDA)
|
Medical-Technical Gases, Inc. |
NITROGEN |
D00083
|
|
OXYGEN gas 99 L00L (NDA)
|
Greene Respiratory Services, Inc |
OXYGEN |
D00003
|
|
Desoximetasone cream 2.5 mg/g (ANDA)
|
Lupin Pharmaceuticals, Inc. |
Desoximetasone |
D03697
|
|
oxygen gas 990 mL/L (NDA)
|
A & E Mill & Welding Supply Company |
oxygen |
D00003
|
|
MEMBRANEBLUE injection, solution .75 mg/.5mL (NDA)
|
Dutch Ophthalmic Research Center (International) B.V. |
trypan blue |
D12658
|
Metolazone tablet 2.5 mg (ANDA)
Metolazone tablet 5 mg (ANDA)
Metolazone tablet 10 mg (ANDA)
|
Sandoz Inc |
Metolazone |
D00431
|
Dexmethylphenidate Hydrochloride tablet 2.5 mg (ANDA)
Dexmethylphenidate Hydrochloride tablet 5 mg (ANDA)
Dexmethylphenidate Hydrochloride tablet 10 mg (ANDA)
|
KVK-TECH, INC |
Dexmethylphenidate Hydrochloride |
D03721
|
|
Simvastatin tablet, film coated 40 mg (ANDA)
|
A-S Medication Solutions |
Simvastatin |
D00434
|
Irbesartan tablet 75 mg (ANDA)
Irbesartan tablet 150 mg (ANDA)
Irbesartan tablet 300 mg (ANDA)
|
Aurobindo Pharma Limited |
Irbesartan |
D00523
|
|
Rosuvastatin tablet, film coated 10 mg (ANDA)
|
Preferred Pharmaceuticals Inc. |
Rosuvastatin |
D01915
|
|
Anthim solution 100 mg/mL (BLA)
|
Elusys Therapeutics, Inc. |
obiltoxaximab |
D10776
|
|
Potassium chloride tablet, film coated, extended release 750 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC |
Potassium Chloride |
D02060
|
|
Simvastatin tablet, film coated 5 mg (ANDA)
|
A-S Medication Solutions |
Simvastatin |
D00434
|
|
isoniazid tablet 300 mg (ANDA)
|
Coupler LLC |
isoniazid |
D00346
|