| Product |
Company |
Generic name |
KEGG DRUG |
|
Flucelvax Quadrivalent injection, suspension 15 ug/.5mL (BLA)
|
Bamboo US BidCo LLC
|
INFLUENZA A VIRUS A/Georgia/12/2022 CVR-167 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/Darwin/11/2021 (H3N2) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED),INFLUENZA B VIRUS B/Singapore/WUH4618/2021 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED),INFLUENZA B VIRUS B/Singapore/INFTT-16-0610/2016 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)
|
D04536
|
|
GARDASIL 9 injection, suspension 40 ug/.5mL (BLA)
|
Bamboo US BidCo LLC
|
Human Papillomavirus 9-valent Vaccine, Recombinant
|
D11863
|
VAQTA injection, suspension 25 [iU]/.5mL (BLA)
VAQTA injection, suspension 50 [iU]/mL (BLA)
|
Bamboo US BidCo LLC
|
hepatitis A vaccine, inactivated
|
D08778
|
|
HEPLISAV-B injection, solution 20 ug/.5mL (BLA)
|
Bamboo US BidCo LLC
|
Hepatitis B Vaccine (Recombinant) Adjuvanted
|
|
|
M-M-R II injection, powder, lyophilized, for suspension 1000 [TCID_50]/.5mL (BLA)
|
Bamboo US BidCo LLC
|
measles, mumps, and rubella virus vaccine live
|
|
|
Ciprofloxacin tablet 500 mg (ANDA)
|
NuCare Pharmaceuticals,Inc.
|
Ciprofolxacin
|
D02216
|
METFORMIN HYDROCHLORIDE tablet 850 mg (ANDA)
METFORMIN HYDROCHLORIDE tablet 500 mg (ANDA)
METFORMIN HYDROCHLORIDE tablet 1000 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC
|
METFORMIN HYDROCHLORIDE
|
D00944
|
|
Prednisolone tablet 5 mg (ANDA)
|
Chartwell RX, LLC
|
Prednisolone
|
D00472
|
Sildenafil tablet, film coated 25 mg (ANDA)
Sildenafil tablet, film coated 50 mg (ANDA)
Sildenafil tablet, film coated 100 mg (ANDA)
|
Aurobindo Pharma Limited
|
Sildenafil
|
D02229
|
Medrol tablet 4 mg (NDA)
Medrol tablet 8 mg (NDA)
Medrol tablet 16 mg (NDA)
Medrol tablet 2 mg (NDA)
|
Pharmacia & Upjohn Company LLC
|
methylprednisolone
|
D00407
|
Buspirone Hydrochloride tablet 5 mg (ANDA)
Buspirone Hydrochloride tablet 7.5 mg (ANDA)
Buspirone Hydrochloride tablet 10 mg (ANDA)
Buspirone Hydrochloride tablet 15 mg (ANDA)
Buspirone Hydrochloride tablet 30 mg (ANDA)
|
APNAR PHARMA LP
|
Buspirone Hydrochloride
|
D00702
|
|
Acetaminophen and Codeine Phosphate tablet 300 mg (ANDA)
|
REMEDYREPACK INC.
|
Acetaminophen and Codeine Phosphate
|
D02146
|
|
Metformin Hydrochloride tablet, extended release 500 mg (ANDA)
|
American Health Packaging
|
Metformin Hydrochloride
|
D00944
|
|
Ciprofloxacin tablet 500 mg (ANDA)
|
Preferred Pharmaceuticals Inc.
|
Ciprofolxacin
|
D02216
|
|
Imipenem and Cilastatin injection, powder, for solution 500 mg (ANDA)
|
WG Critical Care, LLC
|
Imipenem and Cilastatin
|
D00344
|
Olanzapine tablet, orally disintegrating 5 mg (ANDA)
Olanzapine tablet, orally disintegrating 10 mg (ANDA)
Olanzapine tablet, orally disintegrating 15 mg (ANDA)
Olanzapine tablet, orally disintegrating 20 mg (ANDA)
|
Aurobindo Pharma Limited
|
Olanzapine
|
D00454
|
atorvastatin calcium tablet 80 mg (ANDA)
atorvastatin calcium tablet 40 mg (ANDA)
atorvastatin calcium tablet 20 mg (ANDA)
atorvastatin calcium tablet 10 mg (ANDA)
|
Zydus Pharmaceuticals USA Inc.
|
atorvastatin calcium
|
D02258
|
|
Simvastatin tablet, film coated 5 mg (ANDA)
|
REMEDYREPACK INC.
|
Simvastatin
|
D00434
|
|
Colchicine tablet, film coated .6 mg (ANDA)
|
Mylan Institutional Inc.
|
Colchicine
|
D00570
|
|
Galafold capsule 123 mg (NDA)
|
Amicus Therapeutics US, LLC
|
migalastat hydrochloride
|
D05031
|
|
AMOXICILLIN AND CLAVULANATE POTASSIUM tablet, film coated 500 mg (ANDA)
|
REMEDYREPACK INC.
|
Amoxicillin and Clavulanate Potassium
|
D06485
|
|
Azithromycin Dihydrate tablet, film coated 500 mg (ANDA)
|
REMEDYREPACK INC.
|
Azithromycin dihydrate
|
D02134
|
|
Promethazine Hydrochloride solution 6.25 mg/5mL (ANDA)
|
PAI Holdings, LLC dba PAI Pharma
|
Promethazine Hydrochloride
|
D00480
|
|
OCUFLOX solution/ drops 3 mg/mL (NDA)
|
Allergan, Inc.
|
ofloxacin
|
D00453
|
Depo-Medrol injection, suspension 20 mg/mL (NDA)
Depo-Medrol injection, suspension 40 mg/mL (NDA)
Depo-Medrol injection, suspension 80 mg/mL (NDA)
|
Pharmacia & Upjohn Company LLC
|
methylprednisolone acetate
|
D00979
|
|
Colchicine tablet, film coated .6 mg (ANDA)
|
Mylan Pharmaceuticals Inc.
|
Colchicine
|
D00570
|
Omeprazole capsule, delayed release 10 mg (ANDA)
Omeprazole capsule, delayed release 20 mg (ANDA)
Omeprazole capsule, delayed release 40 mg (ANDA)
|
Aurobindo Pharma Limited
|
Omeprazole
|
D00455
|
PredniSONE tablet 20 mg (ANDA)
PredniSONE tablet 50 mg (ANDA)
PredniSONE tablet 5 mg (ANDA)
|
Cardinal Health 107, LLC
|
PredniSONE
|
D00473
|
Depo-Medrol injection, suspension 40 mg/mL (NDA)
Depo-Medrol injection, suspension 80 mg/mL (NDA)
|
Pharmacia & Upjohn Company LLC
|
methylprednisolone acetate
|
D00979
|
|
Desferal injection, powder, lyophilized, for solution 500 mg (NDA)
|
Novartis Pharmaceuticals Corporation
|
deferoxamine mesylate
|
D01186
|
|
Atorvastatin Calcium tablet 20 mg (ANDA)
|
Preferred Pharmaceuticals Inc.
|
atorvastatin calcium, film coated
|
D02258
|
|
Icatibant injection 30 mg/3mL (ANDA)
|
Alembic Pharmaceuticals Inc.
|
Icatibant
|
D04492
|
RYTELO injection, powder, lyophilized, for solution 188 mg (NDA)
RYTELO injection, powder, lyophilized, for solution 47 mg (NDA)
|
Geron Corporation
|
imetelstat sodium
|
D09630
|
|
simvastatin tablet, film coated 5 mg (ANDA)
|
REMEDYREPACK INC.
|
simvastatin
|
D00434
|
Fenofibric Acid capsule, delayed release 45 mg (ANDA)
Fenofibric Acid capsule, delayed release 135 mg (ANDA)
|
Slate Run Pharmaceuticals, LLC
|
Fenofibric Acid
|
D08890
|
|
Fingolimod capsule .5 mg (ANDA)
|
XLCare Pharmaceuticals Inc.
|
Fingolimod
|
D04187
|
Valsartan and Hydrochlorothiazide tablet, film coated 12.5 mg (ANDA)
Valsartan and Hydrochlorothiazide tablet, film coated 25 mg (ANDA)
|
Aurobindo Pharma Limited
|
Valsartan and Hydrochlorothiazide
|
D09197
|
SOLU-MEDROL injection, powder, for solution 500 mg/mL (NDA)
SOLU-MEDROL injection, powder, for solution 1 g/mL (NDA)
SOLU-MEDROL injection, powder, for solution 40 mg/mL (NDA)
SOLU-MEDROL injection, powder, for solution 125 mg/2mL (NDA)
SOLU-MEDROL injection, powder, for solution 500 mg/4mL (NDA)
SOLU-MEDROL injection, powder, for solution 1 g/8mL (NDA)
SOLU-MEDROL injection, powder, for solution 2 g/30.6mL (NDA)
|
Pharmacia & Upjohn Company LLC
|
methylprednisolone sodium succinate
|
D00751
|
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate tablet 1.25 mg (ANDA)
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate tablet 1.875 mg (ANDA)
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate tablet 2.5 mg (ANDA)
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate tablet 3.125 mg (ANDA)
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate tablet 3.75 mg (ANDA)
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate tablet 5 mg (ANDA)
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate tablet 7.5 mg (ANDA)
|
Teva Pharmaceuticals USA, Inc.
|
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate
|
D11624
|
|
Albuterol Sulfate solution 2.5 mg/3mL (ANDA)
|
Cardinal Health 107, LLC
|
Albuterol Sulfate
|
D00683
|