| Product |
Company |
Generic name |
KEGG DRUG |
PRISMASOL BGK2/0 injection 2.03 g/L (NDA)
PRISMASOL BGK2/3.5 injection 5.15 g/L (NDA)
PRISMASOL BGK4/2.5 injection 3.68 g/L (NDA)
PRISMASOL BGK0/2.5 injection 3.68 g/L (NDA)
PRISMASOL B22GK4/0 injection 3.05 g/L (NDA)
PRISMASOL BK0/0/1.2 injection 2.44 g/L (NDA)
PRISMASOL BGK4/0/1.2 injection 2.44 g/L (NDA)
PHOXILLUM BK4/2.5 injection 3.68 g/L (NDA)
PHOXILLUM B22K4/0 injection 3.05 g/L (NDA)
|
Vantive US Healthcare LLC |
magnesium chloride, dextrose anhydrous, lactic acid, sodium chloride, sodium bicarbonate, and potassium chloride |
|
|
CLINDAMYCIN HYDROCHLORIDE capsule 300 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc. |
Clindamycin hydrochloride |
D02132
|
|
Tetracaine Hydrochloride solution 5 mg/mL (ANDA)
|
Sportpharm LLC |
Tetracaine Hydrochloride |
D00741
|
|
Gabapentin tablet 800 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc. |
Gabapentin |
D00332
|
Piperacillin and Tazobactam injection, powder, lyophilized, for solution 2 g0mL (ANDA)
Piperacillin and Tazobactam injection, powder, lyophilized, for solution 3 g5mL (ANDA)
Piperacillin and Tazobactam injection, powder, lyophilized, for solution 4 g/20mL (ANDA)
|
Sandoz Inc |
Piperacillin and Tazobactam |
D02505
|
|
FLUAD injection, suspension 15 ug/.5mL (BLA)
|
Seqirus, Inc. |
INFLUENZA A VIRUS A/Missouri/11/2025 IVR-279 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/Michigan/105/2025 IVR-285 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/Tokyo/EIS13-175/2025 ANTIGEN (FORMALDEHYDE INACTIVATED) |
D04536
|
|
Olanzapine tablet, film coated 20 mg (ANDA)
|
REMEDYREPACK INC. |
Olanzapine |
D00454
|
|
Tizanidine tablet 4 mg (ANDA)
|
REMEDYREPACK INC. |
Tizanidine |
D00776
|
|
Albuterol Sulfate aerosol, metered 90 ug (ANDA)
|
HAWAII REPACK, INC. |
Albuterol Sulfate |
D00683
|
|
Trelstar kit (NDA)
|
Verity Pharmaceuticals Inc. |
triptorelin pamoate |
D06248
|
|
Olanzapine tablet, film coated 10 mg (ANDA)
|
REMEDYREPACK INC. |
Olanzapine |
D00454
|
|
JANUMET tablet, film coated 50 mg (NDA)
|
A-S Medication Solutions |
SITAGLIPTIN and METFORMIN HYDROCHLORIDE |
D10261
|
|
Minocycline Hydrochloride capsule 100 mg (ANDA)
|
Preferred Pharmaceuticals Inc. |
Minocycline Hydrochloride |
D00850
|
|
Hydrochlorothiazide capsule 12.5 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc. |
Hydrochlorothiazide |
D00340
|
|
CLINDAMYCIN HYDROCHLORIDE capsule 150 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc. |
Clindamycin hydrochloride |
D02132
|
|
JANUVIA tablet, film coated 50 mg (NDA)
|
A-S Medication Solutions |
sitagliptin |
D06645
|
|
Ondansetron Hydrochloride tablet, film coated 4 mg (ANDA)
|
REMEDYREPACK INC. |
Ondansetron Hydrochloride |
D00678
|
|
Triamterene and Hydrochlorothiazide tablet 37.5 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc. |
Triamterene and Hydrochlorothiazide |
D10269
|
DEXMEDETOMIDINE HYDROCHLORIDE injection, solution 200 ug/50mL (ANDA)
DEXMEDETOMIDINE HYDROCHLORIDE injection, solution 400 ug00mL (ANDA)
|
Mylan Institutional LLC |
DEXMEDETOMIDINE HYDROCHLORIDE |
D01205
|
Diazepam injection 5 mg/mL (ANDA)
Diazepam injection, solution 5 mg/mL (ANDA)
|
Hikma Pharmaceuticals USA Inc. |
Diazepam |
D00293
|
|
Clindamycin hydrochloride capsule 300 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc. |
Clindamycin hydrochloride |
D02132
|
|
PIFELTRO tablet, film coated 100 mg (NDA)
|
A-S Medication Solutions |
doravirine |
D10624
|
|
topiramate tablet, film coated 200 mg (ANDA)
|
REMEDYREPACK INC. |
topiramate |
D00537
|
|
Trazodone Hydrochloride tablet 50 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc. |
Trazodone Hydrochloride |
D00820
|
|
Chloroquine Phosphate tablet 500 mg (ANDA)
|
Rising Pharma Holdings, Inc. |
Chloroquine Phosphate |
D02125
|
|
Amoxicillin for suspension 400 mg/5mL (NDA AUTHORIZED GENERIC)
|
USAntibiotics, LLC |
Amoxicillin |
D00229
|
ASMANEX inhalant 220 ug (NDA)
ASMANEX inhalant 110 ug (NDA)
|
Organon LLC |
Mometasone Furoate |
D00690
|
AMOXICILLIN capsule 500 mg (ANDA)
AMOXICILLIN capsule 250 mg (ANDA)
|
USAntibiotics, LLC |
Amoxicillin |
D00229
|
|
buprenorphine hydrochloride tablet 8 mg (ANDA)
|
REMEDYREPACK INC. |
buprenorphine hydrochloride |
D00836
|
Metformin hydrochloride tablet, extended release 500 mg (ANDA)
Metformin hydrochloride ER tablet, extended release 750 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc. |
Metformin hydrochloride |
D00944
|
|
JANUVIA tablet, film coated 50 mg (NDA)
|
A-S Medication Solutions |
sitagliptin |
D06645
|
Isotretinoin capsule 10 mg (ANDA)
Isotretinoin capsule 20 mg (ANDA)
Isotretinoin capsule 30 mg (ANDA)
Isotretinoin capsule 40 mg (ANDA)
|
Zydus Pharmaceuticals USA Inc. |
Isotretinoin |
D00348
|
TERIFLUNOMIDE tablet, film coated 14 mg41 (ANDA)
TERIFLUNOMIDE tablet, film coated 7 mg (ANDA)
|
CONCORD BIOTECH LIMITED |
TERIFLUNOMIDE |
D10172
|
|
Gvoke VialDx injection, solution 1 mg/.2mL (NDA)
|
American Regent, Inc. |
glucagon injection |
D00116
|
Venlafaxine Hydrochloride tablet 25 mg (ANDA)
Venlafaxine Hydrochloride tablet 37.5 mg (ANDA)
Venlafaxine Hydrochloride tablet 50 mg (ANDA)
Venlafaxine Hydrochloride tablet 75 mg (ANDA)
Venlafaxine Hydrochloride tablet 100 mg (ANDA)
|
Yaopharma Co., Ltd. |
venlafaxine hydrochloride |
D00821
|
|
Metronidazole tablet, film coated 250 mg (ANDA)
|
Preferred Pharmaceuticals Inc. |
Metronidazole |
D00409
|
|
Qutenza kit (NDA)
|
Averitas Pharma Inc |
capsaicin |
D00250
|
|
Alprazolam tablet .25 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc. |
Alprazolam |
D00225
|
|
Amoxicillin and Clavulanate Potassium tablet, film coated, extended release 562.5 mg (NDA AUTHORIZED GENERIC)
|
USAntibiotics, LLC |
amoxicillin and clavulanate potassium |
D06485
|
|
ziprasidone capsule 60 mg (ANDA)
|
REMEDYREPACK INC. |
ziprasidone |
D01939
|