| Product |
Company |
Generic name |
KEGG DRUG |
|
Air gas 1000 mL/L (NDA)
|
Oxarc, LLC |
Air |
D03043
|
|
Oxygen gas 990 mL/L (NDA)
|
Mississippi Welders Supply Company, Inc. |
Oxygen |
D00003
|
Palynziq injection, solution 2.5 mg/.5mL (BLA)
Palynziq injection, solution 20 mg/mL (BLA)
Palynziq injection, solution 10 mg/.5mL (BLA)
|
BioMarin Pharmaceutical Inc. |
pegvaliase-pqpz |
D11077
|
|
ETOPOPHOS injection, powder, lyophilized, for solution 100 mg (NDA)
|
H2-Pharma, LLC |
etoposide phosphate |
D04107
|
|
Nitrogen gas 990 mL/L (NDA)
|
Oxarc, LLC |
Nitrogen |
D00083
|
|
Atenolol tablet 100 mg (ANDA)
|
St Mary's Medical Park Pharmacy |
Atenolol |
D00235
|
|
Ibuprofen tablet, film coated 600 mg (ANDA)
|
St. Mary's Medical Park Pharmacy |
Ibuprofen |
D00126
|
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
|
|
Leuprolide Acetate kit (ANDA)
|
Sandoz Inc |
Leuprolide Acetate |
D00989
|
|
Nabumetone tablet 500 mg (ANDA)
|
St. Mary's Medical Park Pharmacy |
Nabumetone |
D00425
|
|
Priorix kit (BLA)
|
GlaxoSmithKline Biologicals SA |
Measels, Mumps, and Rubella Vaccine, Live |
|
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
|
|
Carbamazepine tablet 200 mg (ANDA)
|
REMEDYREPACK INC. |
Carbamazepine |
D00252
|
|
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
|
|
ALDURAZYME injection, solution, concentrate 2.9 mg/5mL (BLA)
|
Genzyme Corporation |
laronidase |
D04670
|
|
ACD-A solution 7.3 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
|
|
Sevenfact kit (BLA)
|
Laboratoire Français du Fractionnement et des Biotechnologies Société Anonyme (LFB S.A.) |
Coagulation Factor VIIa Recombinant Human |
D00172
|
|
Nitrogen gas 990 mL/L (NDA)
|
DJB Gas Services, Inc |
Nitrogen |
D00083
|
|
budesonide aerosol, foam 2 mg (NDA)
|
Oceanside Pharmaceuticals |
budesonide |
D00246
|
|
Nitrogen gas 990 mL/L (NDA)
|
Dale Oxygen And Acetylene Service, Inc |
Nitrogen |
D00083
|
|
TRAMADOL HYDROCHLORIDE tablet, extended release 300 mg (ANDA)
|
REMEDYREPACK INC. |
TRAMADOL HYDROCHLORIDE |
D01355
|
Ketamine Hydrochloride injection, solution 10 mg/mL (ANDA)
Ketamine Hydrochloride injection, solution 50 mg/mL (ANDA)
Ketamine Hydrochloride injection, solution 100 mg/mL (ANDA)
|
Gland Pharma Limited |
Ketamine Hydrochloride |
D00711
|
|
Aripiprazole tablet 15 mg (ANDA)
|
REMEDYREPACK INC. |
Aripiprazole |
D01164
|
|
Ethambutol Hydrochloride tablet 400 mg (ANDA)
|
REMEDYREPACK INC. |
Ethambutol Hydrochloride |
D00878
|
|
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
|
|
Oxygen gas 990 mL/L (NDA)
|
DJB Gas Services, Inc |
Oxygen |
D00003
|
|
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
|
Bupropion hydrochloride tablet, extended release 150 mg (ANDA)
Bupropion hydrochloride tablet, extended release 300 mg (ANDA)
|
Granules Pharmaceuticals Inc. |
Bupropion hydrochloride |
D00817
|
|
Desoximetasone cream .5 mg/g (ANDA)
|
Lupin Pharmaceuticals, Inc. |
Desoximetasone |
D03697
|
|
SOTALOL HYDROCHLORIDE tablet 160 mg (ANDA)
|
Bryant Ranch Prepack |
SOTALOL HYDROCHLORIDE |
D01026
|
|
Incruse Ellipta aerosol, powder 62.5 ug (NDA)
|
GlaxoSmithKline LLC |
umeclidinium |
D10181
|
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
|