| Product |
Company |
Generic name |
KEGG DRUG |
|
CP2D solution 4.64 g00mL (NDA)
|
GVS TM INC |
CP2D |
D02955
|
|
FLUZONE HIGH DOSE NORTHERN HEMISPHERE injection, suspension 60 ug/.5mL (BLA)
|
Patheon Manufacturing Services LLC |
influenza a virus a/victoria/4897/2022 ivr-238 (h1n1) antigen (formaldehyde inactivated), influenza a virus a/croatia/10136/rv/2023 (h3n2) antigen (formaldehyde inactivated), and influenza b virus b/michigan/01/2021 antigen (formaldehyde inactivated) |
D04536
|
|
Darunavir tablet, film coated 800 mg (ANDA)
|
NuCare Pharmaceuticals, Inc. |
Darunavir |
D12752
|
|
Allopurinol tablet 100 mg (ANDA)
|
ST. MARY'S MEDICAL PARK PHARMACY |
Allopurinol |
D00224
|
|
Intralipid emulsion 20 g00mL (NDA)
|
ProPharma Distribution |
I.V. Fat Emulsion |
D04962
|
|
mycophenolate mofetil injection, powder, lyophilized, for solution 500 mg/20mL (ANDA)
|
ONESOURCE SPECIALTY PHARMA LIMITED |
mycophenolate mofetil |
D00752
|
|
MESNEX tablet, film coated 400 mg (NDA)
|
Baxter Healthcare Company |
MESNA |
D01459
|
ISOTRETINOIN capsule 10 mg (ANDA)
ISOTRETINOIN capsule 20 mg (ANDA)
ISOTRETINOIN capsule 25 mg (ANDA)
ISOTRETINOIN capsule 30 mg (ANDA)
ISOTRETINOIN capsule 35 mg (ANDA)
ISOTRETINOIN capsule 40 mg (ANDA)
|
Aurobindo Pharma Limited |
ISOTRETINOIN |
D00348
|
|
hydroxyzine pamoate capsule 25 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc. |
hydroxyzine pamoate |
D01096
|
|
Nitroglycerin injection, solution 5 mg/mL (ANDA)
|
Henry Schein, Inc. |
Nitroglycerin |
D00515
|
|
Proctosol-HC cream 25 mg/g (ANDA)
|
Bryant Ranch Prepack |
Hydrocortisone |
D00088
|
|
Diclofenac Potassium tablet, film coated 50 mg (ANDA)
|
Ingenus Pharmaceuticals, LLC |
diclofenac potassium |
D00903
|
|
Vardenafil Hydrochloride tablet 10 mg (ANDA)
|
Bryant Ranch Prepack |
Vardenafil Hydrochloride |
D03260
|
|
Tamoxifen Citrate tablet 20 mg (ANDA)
|
A-S Medication Solutions |
Tamoxifen Citrate |
D00966
|
DESIPRAMINE HYDROCHLORIDE tablet 10 mg (ANDA)
DESIPRAMINE HYDROCHLORIDE tablet 25 mg (ANDA)
DESIPRAMINE HYDROCHLORIDE tablet 50 mg (ANDA)
DESIPRAMINE HYDROCHLORIDE tablet 75 mg (ANDA)
DESIPRAMINE HYDROCHLORIDE tablet 100 mg (ANDA)
DESIPRAMINE HYDROCHLORIDE tablet 150 mg (ANDA)
|
Ingenus Pharmaceuticals, LLC |
desipramine hydrochloride |
D00812
|
Diltiazem Hydrochloride tablet, extended release 180 mg (NDA AUTHORIZED GENERIC)
Diltiazem Hydrochloride tablet, extended release 240 mg (NDA AUTHORIZED GENERIC)
Diltiazem Hydrochloride tablet, extended release 300 mg (NDA AUTHORIZED GENERIC)
Diltiazem Hydrochloride tablet, extended release 360 mg (NDA AUTHORIZED GENERIC)
Diltiazem Hydrochloride tablet, extended release 420 mg (NDA AUTHORIZED GENERIC)
Diltiazem Hydrochloride tablet, extended release 120 mg (NDA AUTHORIZED GENERIC)
|
Oceanside Pharmaceuticals |
Diltiazem Hydrochloride Extended-Release Tablets |
D00616
|
|
Glycopyrrolate injection, solution .2 mg/mL (ANDA)
|
Henry Schein, Inc. |
Glycopyrrolate |
D00540
|
|
Ciprofloxacin tablet, film coated 500 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc. |
Ciprofloxacin |
D02216
|
|
Raloxifene Hydrochloride tablet, film coated 60 mg (ANDA)
|
A-S Medication Solutions |
Raloxifene Hydrochloride |
D02217
|
|
hydroxyzine pamoate capsule 25 mg (ANDA)
|
Bryant Ranch Prepack |
hydroxyzine pamoate |
D01096
|
KYMBEE tablet 6 mg (ANDA)
KYMBEE tablet 18 mg (ANDA)
KYMBEE tablet 30 mg (ANDA)
KYMBEE tablet 36 mg (ANDA)
|
Upsher-Smith Laboratories, LLC |
Deflazacort |
D03671
|
|
Imiquimod cream 12.5 mg/.25g (ANDA)
|
Bryant Ranch Prepack |
Imiquimod |
D02500
|
|
Triamcinolone Acetonide suspension 40 mg/mL (ANDA)
|
Long Grove Pharmaceuticals, LLC |
Triamcinolone Acetonide |
D00983
|
Primidone tablet 50 mg (ANDA)
Primidone tablet 250 mg (ANDA)
|
AvPAK |
Primidone |
D00474
|
|
RISPERDAL CONSTA kit (NDA)
|
Janssen Pharmaceuticals, Inc. |
risperidone |
D00426
|
|
Terazosin capsule 2 mg (ANDA)
|
Bryant Ranch Prepack |
Terazosin Hydrochloride |
D11585
|
GABAPENTIN capsule 100 mg (ANDA)
GABAPENTIN capsule 300 mg (ANDA)
GABAPENTIN capsule 400 mg (ANDA)
|
Granules Pharmaceuticals Inc |
GABAPENTIN |
D00332
|
|
Glimepiride tablet 4 mg (ANDA)
|
REMEDYREPACK INC. |
Glimepiride |
D00593
|
|
DEPO-MEDROL injection, suspension 40 mg/mL (NDA)
|
A-S Medication Solutions |
methylprednisolone acetate |
D00979
|
|
BREKIYA injection 1 mg/mL (NDA)
|
Amneal Pharmaceuticals LLC |
Dihydroergotamine Mesylate |
D02211
|
|
Ciprofloxacin tablet, film coated 500 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc. |
Ciprofloxacin Hydrochloride |
D02216
|
|
Potassium Chloride Extended-Release tablet, extended release 750 mg (ANDA)
|
A-S Medication Solutions |
Potassium Chloride |
D02060
|
|
Carbamazepine capsule, extended release 300 mg (ANDA)
|
Bryant Ranch Prepack |
Carbamazepine |
D00252
|
Clobazam tablet 10 mg (ANDA)
Clobazam tablet 20 mg (ANDA)
|
Lupin Pharmaceuticals, Inc. |
Clobazam |
D01253
|
|
Terrell liquid 1 mL/mL (ANDA)
|
Piramal Critical Care Inc |
Isoflurane |
D00545
|
|
Pacerone tablet 100 mg (ANDA)
|
Bryant Ranch Prepack |
Amiodarone Hydrochloride |
D00636
|
|
Potassium Chloride Extended-release tablet, extended release 1500 mg (ANDA)
|
A-S Medication Solutions |
Potassium Chloride Extended-release |
D02060
|
|
Propofol injection, emulsion 10 mg/mL (ANDA)
|
Avenacy, LLC |
propofol |
D00549
|
RIVAROXABAN kit (ANDA)
RIVAROXABAN tablet, film coated 10 mg (ANDA)
RIVAROXABAN tablet, film coated 15 mg (ANDA)
RIVAROXABAN tablet, film coated 20 mg (ANDA)
RIVAROXABAN tablet, film coated 2.5 mg (ANDA)
|
Alembic Pharmaceuticals Inc. |
RIVAROXABAN |
D07086
|
Esomeprazole Magnesium capsule, delayed release pellets 20 mg (ANDA)
Esomeprazole Magnesium capsule, delayed release pellets 40 mg (ANDA)
|
Lannett Company, Inc. |
Esomeprazole Magnesium |
D11114
|