| Product |
Company |
Generic name |
KEGG DRUG |
|
Rosuvastatin tablet, film coated 20 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC |
Rosuvastatin |
D01915
|
|
METFORMIN HYDROCHLORIDE tablet 850 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC |
METFORMIN HYDROCHLORIDE |
D00944
|
|
PYQUVI suspension 22.75 mg/mL (ANDA)
|
Aucta Pharmaceuticals, Inc. |
deflazacort |
D03671
|
Alprazolam tablet 2 mg (ANDA)
Alprazolam tablet .25 mg (ANDA)
Alprazolam tablet 1 mg (ANDA)
|
A-S Medication Solutions |
Alprazolam |
D00225
|
CLOZAPINE tablet 25 mg (ANDA)
CLOZAPINE tablet 50 mg (ANDA)
CLOZAPINE tablet 100 mg (ANDA)
CLOZAPINE tablet 200 mg (ANDA)
|
Aurobindo Pharma Limited |
CLOZAPINE |
D00283
|
|
Amantadine Hydrochloride capsule, gelatin coated 100 mg (ANDA)
|
Upsher-Smith Laboratories, LLC |
amantadine hydrochloride |
D00777
|
TOPIRAMATE tablet 25 mg (ANDA)
TOPIRAMATE tablet 50 mg (ANDA)
TOPIRAMATE tablet 100 mg (ANDA)
TOPIRAMATE tablet 200 mg (ANDA)
|
XLCare Pharmaceuticals, Inc. |
Topiramate |
D00537
|
|
Metformin Hydrochloride tablet 500 mg (ANDA)
|
A-S Medication Solutions |
Metformin Hydrochloride |
D00944
|
|
Indapamide tablet, film coated 2.5 mg (ANDA)
|
Preferred Pharmaceuticals Inc. |
Indapamide |
D00345
|
|
Irbesartan tablet 75 mg (ANDA)
|
REMEDYREPACK INC. |
Irbesartan |
D00523
|
|
FLUZONE TRIVALENT NORTHERN HEMISPHERE injection, suspension 15 ug/.5mL (BLA)
|
Sanofi Pasteur Inc. |
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
|
|
Amitriptyline Hydrochloride tablet, coated 50 mg (ANDA)
|
A-S Medication Solutions |
Amitriptyline Hydrochloride |
D00809
|
Adrenalin (epinephrine in sodium chloride) injection 16 ug/mL (NDA)
Adrenalin (epinephrine in sodium chloride) injection 32 ug/mL (NDA)
Adrenalin (epinephrine in sodium chloride) injection 8 ug/mL (NDA)
Adrenalin (epinephrine in sodium chloride) injection 20 ug/mL (NDA)
Adrenalin (epinephrine in sodium chloride) injection 40 ug/mL (NDA)
|
Par Health USA, LLC |
Epinephrine in Sodium Chloride |
D00095
|
|
Ipratropium Bromide and Albuterol Sulfate solution 3 mg/3mL (ANDA)
|
Preferred Pharmaceuticals Inc. |
Ipratropium Bromide and Albuterol Sulfate |
D10256
|
|
BENZTROPINE MESYLATE tablet 2 mg (ANDA)
|
REMEDYREPACK INC. |
BENZTROPINE MESYLATE |
D00778
|
|
valproic acid capsule 250 mg (ANDA)
|
Upsher-Smith Laboratories, LLC |
valproic acid |
D00399
|
azithromycin tablet, film coated 250 mg (ANDA)
azithromycin tablet, film coated 500 mg (ANDA)
|
Major Pharmaceuticals |
azithromycin |
D02134
|
Haloperidol tablet .5 mg (ANDA)
Haloperidol tablet 1 mg (ANDA)
Haloperidol tablet 2 mg (ANDA)
Haloperidol tablet 5 mg (ANDA)
Haloperidol tablet 10 mg (ANDA)
Haloperidol tablet 20 mg (ANDA)
|
Method Pharmaceuticals, LLC |
Haloperidol |
D00136
|
Buspirone Hydrochloride tablet 10 mg (ANDA)
Buspirone Hydrochloride tablet 5 mg (ANDA)
|
Major Pharmaceuticals |
Buspirone Hydrochloride |
D00702
|
|
Ketorolac Tromethamine solution 5 mg/mL (ANDA)
|
Preferred Pharmaceuticals Inc. |
Ketorolac Tromethamine |
D00813
|
Morphine Sulfate capsule, extended release 10 mg (ANDA)
Morphine Sulfate capsule, extended release 20 mg (ANDA)
Morphine Sulfate capsule, extended release 30 mg (ANDA)
Morphine Sulfate capsule, extended release 50 mg (ANDA)
Morphine Sulfate capsule, extended release 60 mg (ANDA)
Morphine Sulfate capsule, extended release 80 mg (ANDA)
Morphine Sulfate capsule, extended release 100 mg (ANDA)
|
Upsher-Smith Laboratories, LLC |
Morphine Sulfate |
D00842
|
|
BUPROPION HYDROCHLORIDE (SR) tablet, extended release 150 mg (ANDA)
|
A-S Medication Solutions |
Bupropion Hydrochloride |
D00817
|
|
Fluocinonide ointment .05 mg/g (ANDA)
|
Bryant Ranch Prepack |
Fluocinonide |
D00325
|
Nicardipine Hydrochloride in Sodium Chloride injection, solution .1 mg/mL (ANDA)
Nicardipine Hydrochloride in Sodium Chloride injection, solution .2 mg/mL (ANDA)
|
WG Critical Care, LLC |
Nicardipine Hydrochloride |
D00617
|
|
Prednisolone Sodium Phosphate solution 15 mg/5mL (ANDA)
|
PAI Holdings, LLC dba PAI Pharma |
Prednisolone Sodium Phosphate |
D00981
|
|
leuprolide acetate kit (ANDA)
|
Sun Pharmaceutical Industries, Inc. |
leuprolide acetate |
D00989
|
Citalopram tablet, film coated 10 mg (ANDA)
Citalopram tablet, film coated 20 mg (ANDA)
|
Major Pharmaceuticals |
Citalopram |
D00822
|
|
Buspirone hydrochloride tablet 15 mg (ANDA)
|
Major Pharmaceuticals |
Buspirone hydrochloride |
D00702
|
|
Hydrocodone Bitartrate and Acetaminophen solution 325 mg5mL (ANDA)
|
Genus Lifesciences Inc. |
hydrocodone bitartrate and acetaminophen |
D00846
|
Midodrine Hydrochloride tablet 2.5 mg (ANDA)
Midodrine Hydrochloride tablet 5 mg (ANDA)
Midodrine Hydrochloride tablet 10 mg (ANDA)
|
Apotex Corp |
Midodrine Hydrochloride |
D01307
|
Fenofibric acid capsule, delayed release 45 mg (ANDA)
Fenofibric acid capsule, delayed release 135 mg (ANDA)
|
Macleods Pharmaceuticals Limited |
Fenofibric acid |
D08890
|
Amnesteem capsule 10 mg (ANDA)
Amnesteem capsule 20 mg (ANDA)
Amnesteem capsule 40 mg (ANDA)
Amnesteem capsule 30 mg (ANDA)
|
Mylan Pharmaceuticals Inc. |
isotretinoin |
D00348
|
|
Amantadine Hydrochloride capsule 100 mg (ANDA)
|
Major Pharmaceuticals |
Amantadine Hydrochloride |
D00777
|
STELARA injection, solution 45 mg/.5mL (BLA)
STELARA injection, solution 90 mg/mL (BLA)
Stelara solution 130 mg/26mL (BLA)
|
Janssen Biotech, Inc. |
ustekinumab |
D09214
|
PROCHLORPERAZINE MALEATE tablet, film coated 5 mg (ANDA)
PROCHLORPERAZINE MALEATE tablet, film coated 10 mg (ANDA)
|
Leading Pharma, LLC |
PROCHLORPERAZINE MALEATE |
D00479
|
|
Ketoconazole shampoo, suspension 20 mg/mL (ANDA)
|
Preferred Pharmaceuticals Inc. |
Ketoconazole |
D00351
|
|
venlafaxine tablet 25 mg (ANDA)
|
REMEDYREPACK INC. |
venlafaxine hydrochloride |
D00821
|
|
Penicillin V Potassium tablet, film coated 500 mg (ANDA)
|
Bryant Ranch Prepack |
Penicillin V Potassium |
D00497
|
|
Isoniazid tablet 300 mg (ANDA)
|
Preferred Pharmaceuticals, Inc. |
Isoniazid |
D00346
|
|
Trintellix tablet, film coated 20 mg (NDA)
|
REMEDYREPACK INC. |
vortioxetine |
D10185
|