| Product |
Company |
Generic name |
KEGG DRUG |
|
CARBIDOPA AND LEVODOPA tablet 25 mg (ANDA)
|
Coupler LLC |
Carbidopa and Levodopa |
D00253
|
|
Amitriptyline Hydrochloride tablet, film coated 25 mg (ANDA)
|
Coupler LLC |
Amitriptyline Hydrochloride |
D00809
|
Buspirone Hydrochloride tablet 10 mg (ANDA)
Buspirone Hydrochloride tablet 5 mg (ANDA)
|
Cardinal Health 107, LLC |
Buspirone Hydrochloride |
D00702
|
HYDROCODONE BITARTRATE AND ACETAMINOPHEN tablet 5 mg (ANDA)
HYDROCODONE BITARTRATE AND ACETAMINOPHEN tablet 7.5 mg (ANDA)
HYDROCODONE BITARTRATE AND ACETAMINOPHEN tablet 10 mg (ANDA)
|
SpecGx LLC |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
D00846
|
|
Clobazam suspension 2.5 mg/mL (ANDA)
|
Bryant Ranch Prepack |
Clobazam |
D01253
|
|
GoLYTELY powder, for solution 236 g/4L (NDA)
|
Azurity Pharmaceuticals, Inc. |
Polyethylene Glycol 3350, Sodium Sulfate Anhydrous, Sodium Bicarbonate, Sodium Chloride, Potassium Chloride |
|
|
TAMSULOSIN HYDROCHLORIDE capsule .4 mg (ANDA)
|
DIRECT RX |
TAMSULOSIN HYDROCHLORIDE |
D01024
|
|
Denosumab-BMWO injection 60 mg/mL (BLA)
|
CELLTRION USA, Inc. |
denosumab-bmwo |
D03684
|
|
Lidocaine injection, solution 10 mg/mL (ANDA)
|
Sportpharm LLC |
Lidocaine Hydrochloride |
D02086
|
|
Diclofenac Sodium Delayed Release tablet, delayed release 75 mg (ANDA)
|
REMEDYREPACK INC. |
Diclofenac Sodium |
D00904
|
|
Valacyclovir tablet 500 mg (ANDA)
|
Preferred Pharmaceuticals Inc. |
Valacyclovir |
D00398
|
|
Mannitol injection, solution 12.5 g/50mL (NDA)
|
Hospira, Inc. |
MANNITOL |
D00062
|
|
Calcium Acetate capsule 667 mg (ANDA)
|
Cardinal Health 107, LLC |
Calcium Acetate |
D00931
|
Memantine Hydrochloride capsule, extended release 7 mg (ANDA)
Memantine Hydrochloride capsule, extended release 14 mg (ANDA)
Memantine Hydrochloride capsule, extended release 21 mg (ANDA)
Memantine Hydrochloride capsule, extended release 28 mg (ANDA)
|
Slate Run Pharmaceuticals, LLC |
memantine hydrochloride |
D04905
|
|
Ringers injection, solution 30 mg00mL (NDA)
|
ICU Medical, Inc. |
SODIUM CHLORIDE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE |
D05329
|
DIANEAL PD-2 with Dextrose injection, solution 1.5 g00mL (NDA)
DIANEAL Low Calcium with Dextrose injection, solution 1.5 g00mL (NDA)
DIANEAL PD-2 with Dextrose injection, solution 2.5 g00mL (NDA)
DIANEAL PD-2 with Dextrose injection, solution 4.25 g00mL (NDA)
DIANEAL Low Calcium with Dextrose injection, solution 2.5 g00mL (NDA)
DIANEAL Low Calcium with Dextrose injection, solution 4.25 g00mL (NDA)
|
Vantive US Healthcare LLC |
sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose |
|
|
PEG 3350 and Electrolytes powder, for solution 236 g/4L (NDA AUTHORIZED GENERIC)
|
Wilshire Pharmaceuticals, Inc. |
Polyethylene Glycol 3350, Sodium Sulfate Anhydrous, Sodium Bicarbonate, Sodium Chloride, Potassium Chloride |
|
|
Ibuprofen and famotidine tablet 800 mg (ANDA)
|
Par Health USA, LLC |
Ibuprofen and famotidine |
D11575
|
Carvedilol tablet, film coated 25 mg (ANDA)
Carvedilol tablet, film coated 3.125 mg (ANDA)
Carvedilol tablet, film coated 12.5 mg (ANDA)
Carvedilol tablet, film coated 6.25 mg (ANDA)
|
Cardinal Health 107, LLC |
Carvedilol |
D00255
|
|
Osenvelt injection 120 mg.7mL (BLA)
|
CELLTRION USA, Inc. |
denosumab-bmwo |
D03684
|
BUPROPION HYDROCHLORIDE tablet, extended release 150 mg (ANDA)
BUPROPION HYDROCHLORIDE tablet, extended release 300 mg (ANDA)
|
Camber Pharmaceuticals, Inc. |
BUPROPION HYDROCHLORIDE |
D00817
|
|
Mefenamic Acid capsule 250 mg (ANDA)
|
Lupin Pharmaceuticals, Inc. |
Mefenamic Acid |
D00151
|
|
Denosumab-BMWO injection 120 mg.7mL (BLA)
|
CELLTRION USA, Inc. |
denosumab-bmwo |
D03684
|
Clarithromycin tablet, film coated 250 mg (ANDA)
Clarithromycin tablet, film coated 500 mg (ANDA)
|
Sportpharm LLC |
Clarithromycin |
D00276
|
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE tablet, extended release 5 mg (ANDA)
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE tablet, extended release 10 mg (ANDA)
|
Lupin Pharmaceuticals, Inc. |
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE |
D10586
|
|
VIGABATRIN powder, for solution 50 mg/mL (ANDA)
|
Par Health USA, LLC |
vigabatrin |
D00535
|
|
Bupropion Hydrochloride tablet, film coated 75 mg (ANDA)
|
Cardinal Health 107, LLC |
Bupropion Hydrochloride |
D00817
|
Bupropion Hydrochloride SR tablet, extended release 100 mg (ANDA)
Bupropion Hydrochloride SR tablet, extended release 150 mg (ANDA)
Bupropion Hydrochloride SR tablet, extended release 200 mg (ANDA)
|
Epic Pharma, LLC |
bupropion hydrochloride |
D00817
|
Amlodipine Besylate tablet 2.5 mg (ANDA)
Amlodipine Besylate tablet 5 mg (ANDA)
Amlodipine Besylate tablet 10 mg (ANDA)
|
Lupin Pharmaceuticals, Inc. |
Amlodipine Besylate |
D00615
|
Tikosyn capsule .125 mg (NDA)
Tikosyn capsule .25 mg (NDA)
Tikosyn capsule .5 mg (NDA)
|
Pfizer Laboratories Div Pfizer Inc |
dofetilide |
D00647
|
|
Amphotericin B injectable, liposomal 50 mg (ANDA)
|
Sun Pharmaceutical Industries, Inc. |
Amphotericin B |
D00203
|
|
VABYSMO injection, solution 6 mg/.05mL (BLA)
|
Genentech, Inc. |
Faricimab |
D11516
|
IRBESARTAN tablet 75 mg (ANDA)
IRBESARTAN tablet 150 mg (ANDA)
IRBESARTAN tablet 300 mg (ANDA)
|
Jubilant Cadista Pharmaceuticals Inc. |
IRBESARTAN |
D00523
|
|
Clonidine Hydrochloride tablet .1 mg (ANDA)
|
Bryant Ranch Prepack |
Clonidine Hydrochloride |
D00604
|
CONCERTA tablet, extended release 18 mg (NDA)
CONCERTA tablet, extended release 36 mg (NDA)
CONCERTA tablet, extended release 54 mg (NDA)
CONCERTA tablet, extended release 27 mg (NDA)
|
Janssen Pharmaceuticals, Inc. |
Methylphenidate hydrochloride |
D01296
|
|
Olanzapine injection, powder, for solution 10 mg/2mL (ANDA)
|
Sandoz Inc |
Olanzapine |
D00454
|
Dexmedetomidine Hydrochloride injection, solution, concentrate 100 ug/mL (ANDA)
Dexmedetomidine Hydrochloride injection, solution 4 ug/mL (ANDA)
|
Par Health USA, LLC |
Dexmedetomidine Hydrochloride |
D01205
|
|
Khindivi solution 1 mg/mL (NDA)
|
Eton Pharmaceuticals, Inc. |
Hydrocortisone |
D00088
|
Diclofenac Potassium tablet, film coated 50 mg (ANDA)
Diclofenac Potassium tablet, film coated 25 mg (ANDA)
|
Umedica Laboratories USA Inc. |
Diclofenac Potassium Tablets |
D00903
|
|
Dicyclomine Hydrochloride capsule 10 mg (ANDA)
|
Bryant Ranch Prepack |
Dicyclomine Hydrochloride |
D00717
|