| Product |
Company |
Generic name |
KEGG DRUG |
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
|
|
Oxycodone and Acetaminophen tablet 325 mg (ANDA)
|
Aurolife Pharma, LLC |
Oxycodone and Acetaminophen |
D02153
|
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
|
|
Hetastarch in Sodium Chloride injection, solution 6 g00mL (ANDA)
|
Hospira, Inc. |
HETASTARCH |
D03335
|
TicoVac injection 2.4 ug/.5mL (BLA)
TicoVac injection 1.2 ug/.25mL (BLA)
|
Pfizer Laboratories Div Pfizer Inc |
Tick-Borne Encephalitis Vaccine |
D12206
|
|
AVSOLA injection, powder, lyophilized, for solution 100 mg0mL (BLA)
|
Amgen, Inc |
infliximab-axxq |
D02598
|
Indapamide tablet, film coated 1.25 mg (ANDA)
Indapamide tablet, film coated 2.5 mg (ANDA)
|
ANI Pharmaceuticals, Inc. |
Indapamide |
D00345
|
Doxepin Hydrochloride capsule 10 mg (ANDA)
Doxepin Hydrochloride capsule 25 mg (ANDA)
Doxepin Hydrochloride capsule 50 mg (ANDA)
Doxepin Hydrochloride capsule 100 mg (ANDA)
|
Major Pharmaceuticals |
Doxepin Hydrochloride |
D00814
|
|
Methocarbamol Tablets, USP, 500 mg tablet, film coated 500 mg (ANDA)
|
Bryant Ranch Prepack |
Methocarbamol |
D00402
|
|
clonidine hydrochloride tablet .1 mg (ANDA)
|
REMEDYREPACK INC. |
clonidine hydrochloride |
D00604
|
Carvedilol tablet, film coated 12.5 mg (ANDA)
Carvedilol tablet, film coated 25 mg (ANDA)
Carvedilol tablet, film coated 3.125 mg (ANDA)
Carvedilol tablet, film coated 6.25 mg (ANDA)
|
BluePoint Laboratories |
Carvedilol |
D00255
|
|
Bexarotene capsule, liquid filled 75 mg (ANDA)
|
ANI Pharmaceuticals, Inc. |
Bexarotene |
D03106
|
Diltiazem Hydrochloride capsule, extended release 120 mg (ANDA)
Diltiazem Hydrochloride capsule, extended release 180 mg (ANDA)
Diltiazem Hydrochloride capsule, extended release 240 mg (ANDA)
Diltiazem Hydrochloride capsule, extended release 300 mg (ANDA)
|
Major Pharmaceuticals |
Diltiazem hydrochloride |
D00616
|
|
Pregabalin capsule 100 mg (ANDA)
|
Preferred Pharmaceuticals Inc. |
Pregabalin |
D02716
|
|
Triamterene and Hydrochlorothiazide tablet 25 mg (ANDA)
|
Bryant Ranch Prepack |
Triamterene and Hydrochlorothiazide |
D10269
|
|
JOURNAVX tablet, film coated 50 mg (NDA)
|
Vertex Pharmaceuticals Incorporated |
Suzetrigine |
D12860
|
CHANTIX tablet, film coated .5 mg (NDA)
CHANTIX tablet, film coated 1 mg (NDA)
|
Pfizer Laboratories Div Pfizer Inc |
varenicline tartrate |
D06282
|
ROPIVACAINE HYDROCHLORIDE injection, solution 2 mg/mL (ANDA)
ROPIVACAINE HYDROCHLORIDE injection, solution 5 mg/mL (ANDA)
ROPIVACAINE HYDROCHLORIDE injection, solution 10 mg/mL (ANDA)
|
Anthea Pharma Private Limited |
ROPIVACAINE HYDROCHLORIDE |
D04048
|
|
Pregabalin capsule 150 mg (ANDA)
|
REMEDYREPACK INC. |
Pregabalin |
D02716
|