| Product |
Company |
Generic name |
KEGG DRUG |
Meropenem injection 1 g/20mL (ANDA)
Meropenem injection 500 mg/20mL (ANDA)
|
Civica, Inc. |
Meropenem |
D02222
|
|
HEMGENIX kit (BLA)
|
CSL Behring |
etranacogene dezaparvovec |
D12500
|
METFORMIN HYDROCHLORIDE tablet, extended release 500 mg (ANDA)
METFORMIN HYDROCHLORIDE tablet, extended release 750 mg (ANDA)
|
Marlex Pharmaceuticals, Inc. |
METFORMIN HYDROCHLORIDE |
D00944
|
|
Famotidine tablet, film coated 20 mg (ANDA)
|
Major Pharmaceuticals |
Famotidine |
D00318
|
|
Potassium Chloride for Oral Solution powder, for solution 1.5 g.58g (ANDA)
|
Marlex Pharmaceuticals, Inc. |
Potassium Chloride for Oral Solution |
D02060
|
|
Pregabalin capsule 225 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC |
Pregabalin |
D02716
|
|
Heparin Sodium injection 1000 [USP'U]/mL (ANDA)
|
Medical Purchasing Solutions, LLC. |
Heparin Sodium |
D02112
|
METOPROLOL TARTRATE tablet 25 mg (ANDA)
METOPROLOL TARTRATE tablet 37.5 mg (ANDA)
METOPROLOL TARTRATE tablet 50 mg (ANDA)
METOPROLOL TARTRATE tablet 75 mg (ANDA)
METOPROLOL TARTRATE tablet 100 mg (ANDA)
|
Advagen Pharma Ltd |
METOPROLOL TARTRATE |
D00601
|
Promethazine Hydrochloride tablet 12.5 mg (ANDA)
Promethazine Hydrochloride tablet 25 mg (ANDA)
Promethazine Hydrochloride tablet 50 mg (ANDA)
|
BluePoint Laboratories |
Promethazine Hydrochloride |
D00480
|
FLUTICASONE PROPIONATE DISKUS powder, metered 50 ug (NDA AUTHORIZED GENERIC)
FLUTICASONE PROPIONATE DISKUS powder, metered 100 ug (NDA AUTHORIZED GENERIC)
FLUTICASONE PROPIONATE DISKUS powder, metered 250 ug (NDA AUTHORIZED GENERIC)
|
Prasco Laboratories |
fluticasone propionate |
D01708
|
Irbesartan and Hydrochlorothiazide tablet, film coated 12.5 mg (ANDA)
Irbesartan and Hydrochlorothiazide tablet, film coated 25 mg (ANDA)
|
Aurobindo Pharma Limited |
Irbesartan and Hydrochlorothiazide |
D10249
|
Digoxin tablet 125 ug (ANDA)
Digoxin tablet 250 ug (ANDA)
|
Major Pharmaceuticals |
Digoxin |
D00298
|
DROXIA capsule 200 mg (NDA)
DROXIA capsule 300 mg (NDA)
DROXIA capsule 400 mg (NDA)
|
Waylis Therapeutics LLC |
Hydroxyurea |
D00341
|
|
doxycycline hyclate tablet, film coated 100 mg (ANDA)
|
Amneal Pharmaceuticals NY LLC |
doxycycline hyclate |
D02129
|
|
Tizanidine tablet 4 mg (ANDA)
|
REMEDYREPACK INC. |
Tizanidine |
D00776
|
|
Triamterene and Hydrochlorothiazide tablet 50 mg (ANDA)
|
Bryant Ranch Prepack |
Triamterene and Hydrochlorothiazide |
D10269
|
|
Clindamycin Palmitate Hydrochloride granule, for solution 75 mg/5mL (ANDA)
|
Chartwell RX, LLC |
Clindamycin Palmitate Hydrochloride |
D01990
|
SUBLOCADE solution 100 mg (NDA)
SUBLOCADE solution 300 mg (NDA)
|
Indivior Inc. |
buprenorphine |
D07132
|
|
Fluocinonide solution .5 mg/mL (ANDA)
|
Bryant Ranch Prepack |
fluocinonide topical solution usp, 0.05% |
D00325
|
dexamethasone tablet 4 mg (ANDA)
dexamethasone tablet 6 mg (ANDA)
|
Major Pharmaceuticals |
dexamethasone |
D00292
|
Krystexxa injection, solution 8 mg/mL (BLA)
Krystexxa injection, solution 8 mg/50mL (BLA)
|
Horizon Therapeutics USA, Inc. |
pegloticase |
D09316
|
Skyrizi injection 150 mg/mL (BLA)
Skyrizi kit (BLA)
Skyrizi injection 600 mg0mL (BLA)
Skyrizi injection 180 mg.2mL (BLA)
|
AbbVie Inc. |
risankizumab-rzaa |
D11052
|
|
Doxycycline Hyclate capsule 100 mg (ANDA)
|
Amneal Pharmaceuticals NY LLC |
Doxycycline |
D02129
|
|
Entacapone tablet, film coated 200 mg (ANDA)
|
Major Pharmaceuticals |
Entacapone |
D00781
|
|
Sotalol Hydrochloride tablet 80 mg (ANDA)
|
Bryant Ranch Prepack |
Sotalol Hydrochloride |
D01026
|
Propafenone Hydrochloride tablet, coated 150 mg (ANDA)
Propafenone Hydrochloride tablet, coated 225 mg (ANDA)
Propafenone Hydrochloride tablet, coated 300 mg (ANDA)
|
ANI Pharmaceuticals, Inc. |
Propafenone Hydrochloride |
D00640
|
|
HYDROCORTISONE tablet 10 mg (ANDA)
|
Major Pharmaceuticals |
hydrocortisone |
D00088
|
|
Fludrocortisone Acetate tablet .1 mg (ANDA)
|
Major Pharmaceuticals |
Fludrocortisone Acetate |
D00986
|
|
oxcarbazepine for suspension 300 mg/5mL (ANDA)
|
Macleods Pharmaceuticals Limited |
oxcarbazepine |
D00533
|
Fluticasone Propionate HFA aerosol, metered 44 ug (NDA AUTHORIZED GENERIC)
Fluticasone Propionate HFA aerosol, metered 110 ug (NDA AUTHORIZED GENERIC)
Fluticasone Propionate HFA aerosol, metered 220 ug (NDA AUTHORIZED GENERIC)
|
Prasco Laboratories |
fluticasone propionate |
D01708
|
LEQEMBI injection, solution 100 mg/mL (BLA)
LECANEMAB AUTOINJECTOR injection, solution 200 mg/mL (BLA)
|
Eisai Inc. |
lecanemab |
D11678
|
|
LISINOPRIL tablet 10 mg (ANDA)
|
Bryant Ranch Prepack |
Lisinopril |
D00362
|
|
Ciprofloxacin tablet, film coated 500 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc. |
Ciprofloxacin Hydrochloride |
D02216
|
Bupropion Hydrochloride tablet, film coated 75 mg (ANDA)
Bupropion Hydrochloride tablet, film coated 100 mg (ANDA)
|
Major Pharmaceuticals |
Bupropion Hydrochloride |
D00817
|
|
MiloPhene tablet 50 mg (ANDA)
|
Burel Pharmaceuticals, LLC |
Clomiphene Citrate |
D00962
|
Morphine Sulfate injection, solution 2 mg/mL (NDA)
Morphine Sulfate injection, solution 4 mg/mL (NDA)
Morphine Sulfate injection, solution 5 mg/mL (NDA)
Morphine Sulfate injection, solution 8 mg/mL (NDA)
Morphine Sulfate injection, solution 10 mg/mL (NDA)
|
Fresenius Kabi USA, LLC |
Morphine Sulfate |
D00842
|
DEFERASIROX granule 90 mg (ANDA)
DEFERASIROX granule 180 mg (ANDA)
DEFERASIROX granule 360 mg (ANDA)
|
Aurobindo Pharma Limited |
DEFERASIROX |
D03669
|
|
Bumetanide tablet 2 mg (ANDA)
|
REMEDYREPACK INC. |
Bumetanide |
D00247
|
|
Pregabalin capsule 100 mg (ANDA)
|
Preferred Pharmaceuticals, Inc. |
PREGABALIN |
D02716
|
|
Oxcarbazepine suspension 300 mg/5mL (ANDA)
|
Marlex Pharmaceuticals, Inc |
Oxcarbazepine |
D00533
|