| Product |
Company |
Generic name |
KEGG DRUG |
|
Helium gas 990 mL/L (NDA)
|
AGL Inhalation Therapy Co. |
Helium |
D04420
|
Trazodone Hydrochloride tablet 50 mg (ANDA)
Trazodone Hydrochloride tablet 100 mg (ANDA)
|
AvKARE |
Trazodone Hydrochloride |
D00820
|
Metformin hydrochloride tablet 500 mg (ANDA)
Metformin hydrochloride tablet 850 mg (ANDA)
Metformin hydrochloride tablet 1000 mg (ANDA)
|
Legacy Pharmaceutical Packaging, LLC |
Metformin hydrochloride |
D00944
|
|
Naltrexone Hydrochloride tablet, film coated 50 mg (ANDA)
|
Bryant Ranch Prepack |
Naltrexone Hydrochloride |
D02095
|
|
Nifedipine tablet, film coated, extended release 30 mg (ANDA)
|
Major Pharmaceuticals |
Nifedipine |
D00437
|
|
Emtricitabine and Tenofovir Disoproxil Fumarate tablet, film coated 200 mg (ANDA)
|
Bryant Ranch Prepack |
Emtricitabine and Tenofovir Disoproxil Fumarate |
D02297
|
|
Paroxetine tablet, film coated 40 mg (ANDA)
|
REMEDYREPACK INC. |
Paroxetine |
D02260
|
Sertraline Hydrochloride tablet 25 mg (ANDA)
Sertraline Hydrochloride tablet 50 mg (ANDA)
Sertraline Hydrochloride tablet 100 mg (ANDA)
|
Legacy Pharmaceutical Packaging, LLC |
Sertraline Hydrochloride |
D00825
|
|
Atorvastatin calcium tablet, film coated 40 mg (ANDA)
|
Bryant Ranch Prepack |
Atorvastatin calcium |
D02258
|
|
CELESTONE SOLUSPAN injection, suspension 3 mg/mL (NDA)
|
Organon LLC |
Betamethasone Acetate and Betamethasone Sodium Phosphate |
D04446
|
TASCENSO ODT tablet, orally disintegrating .25 mg (NDA)
TASCENSO ODT tablet, orally disintegrating .5 mg (NDA)
|
Cycle Pharmaceuticals Ltd |
Fingolimod Lauryl Sulfate |
D12549
|
Nplate injection, powder, lyophilized, for solution 250 ug/.5mL (BLA)
Nplate injection, powder, lyophilized, for solution 500 ug/mL (BLA)
Nplate injection, powder, lyophilized, for solution 125 ug/.25mL (BLA)
|
Amgen, Inc |
romiplostim |
D08990
|
buprenorphine hydrochloride and naloxone hydrochloride dihydrate tablet 8 mg (ANDA)
buprenorphine hydrochloride and naloxone hydrochloride dihydrate tablet 2 mg (ANDA)
|
Major Pharmaceuticals |
buprenorphine hydrochloride and naloxone hydrochloride dihydrate |
D10250
|
|
divalproex sodium tablet, delayed release 250 mg (ANDA)
|
Bryant Ranch Prepack |
divalproex sodium |
D00304
|
|
ELUCIREM injection 485.1 mg/mL (NDA)
|
Guerbet LLC |
gadopiclenol |
D12435
|
|
Metronidazole injection, solution 500 mg00mL (NDA)
|
Baxter Healthcare Corporation |
Metronidazole |
D00409
|
|
Ritonavir tablet, film coated 100 mg (ANDA)
|
Bryant Ranch Prepack |
Ritonavir |
D00427
|
|
Methocarbamol tablet 500 mg (ANDA)
|
Bryant Ranch Prepack |
methocarbamol |
D00402
|
|
Cephalexin capsule 500 mg (ANDA)
|
REMEDYREPACK INC. |
Cephalexin |
D00906
|
|
Recorlev tablet 150 mg (NDA)
|
Xeris Pharmaceuticals, Inc. |
Levoketoconazole |
D10950
|
AMJEVITA injection 20 mg/.2mL (BLA)
AMJEVITA injection 40 mg/.4mL (BLA)
AMJEVITA injection 80 mg/.8mL (BLA)
|
Nuvaila Limited |
adalimumab-atto |
D02597
|
|
Metformin tablet, extended release 500 mg (ANDA)
|
Legacy Pharmaceutical Packaging, LLC |
Metformin ER 500 mg |
D00944
|
Buprenorphine tablet 2 mg (ANDA)
Buprenorphine tablet 8 mg (ANDA)
|
Major Pharmaceuticals |
Buprenorphine |
D00836
|
|
Omeprazole capsule, delayed release 40 mg (ANDA)
|
NuCare Pharmaceuticals,Inc. |
Omeprazole |
D00455
|
|
Ondansetron tablet, orally disintegrating 8 mg (ANDA)
|
Northwind Health Company, LLC |
Ondansetron |
D00456
|
|
LISINOPRIL AND HYDROCHLOROTHIAZIDE tablet 12.5 mg (ANDA)
|
St Marys Medical Park Pharmacy |
LISINOPRIL AND HYDROCHLOROTHIAZIDE |
D10268
|
|
Darunavir tablet, film coated 800 mg (ANDA)
|
Bryant Ranch Prepack |
Darunavir |
D03656
|
Enalapril maleate tablet 5 mg (ANDA)
Enalapril maleate tablet 10 mg (ANDA)
Enalapril maleate tablet 20 mg (ANDA)
|
Legacy Pharmaceutical Packaging, LLC |
Enalapril maleate |
D00621
|
|
ciprofloxacin tablet, film coated 500 mg (ANDA)
|
Major Pharmaceuticals |
ciprofloxacin |
D02216
|
|
Potassium Chloride Extended-Release tablet, extended release 750 mg (ANDA)
|
Bryant Ranch Prepack |
Potassium Chloride |
D02060
|
|
topiramate tablet, film coated 100 mg (ANDA)
|
Northwind Health Company, LLC |
topiramate |
D00537
|
|
Sodium Chloride injection, solution, concentrate 5.84 g/40mL (NDA)
|
Hospira, Inc. |
SODIUM CHLORIDE |
D02056
|
Bupivacaine Hydrochloride injection, solution 2.5 mg/mL (ANDA)
Bupivacaine Hydrochloride injection, solution 5 mg/mL (ANDA)
Bupivacaine Hydrochloride injection, solution 7.5 mg/mL (ANDA)
Bupivacaine Hydrochloride and Epinephrine injection, solution 2.5 mg/mL (ANDA)
Bupivacaine Hydrochloride and Epinephrine injection, solution 5 mg/mL (ANDA)
|
Hospira, Inc. |
BUPIVACAINE HYDROCHLORIDE |
D11569
|
|
Etodolac tablet, film coated 400 mg (ANDA)
|
Bryant Ranch Prepack |
Etodolac |
D00315
|
lamotrigine tablet, for suspension 5 mg (ANDA)
lamotrigine tablet, for suspension 25 mg (ANDA)
|
Alembic Pharmaceuticals Inc. |
lamotrigine |
D00354
|
|
Methocarbamol tablet 500 mg (ANDA)
|
ASCLEMED USA INC. |
methocarbamol |
D00402
|
|
SODIUM BICARBONATE injection, solution 84 mg/mL (ANDA)
|
Hospira, Inc. |
SODIUM BICARBONATE |
D01203
|
|
Sodium Bicarbonate injection, solution 42 mg/mL (ANDA)
|
Hospira, Inc. |
SODIUM BICARBONATE |
D01203
|
|
ropinirole tablet, film coated .5 mg (ANDA)
|
REMEDYREPACK INC. |
ropinirole |
D00784
|
|
Gefitinib tablet, film coated 250 mg (ANDA)
|
Natco Pharma USA LLC |
Gefitinib |
D01977
|