| Product |
Company |
Generic name |
KEGG DRUG |
|
PENTACEL kit (BLA)
|
Sanofi Vaccines US Inc. |
DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, INACTIVATED POLIOVIRUS AND HAEMOPHILUS B CONJUGATE (TETANUS TOXOID CONJUGATE) VACCINE |
D12585
|
|
Digoxin injection .25 mg/mL (ANDA)
|
Cardinal Health 107, LLC |
Digoxin |
D00298
|
|
Gabapentin capsule 100 mg (ANDA)
|
Preferred Pharmaceuticals Inc. |
Gabapentin |
D00332
|
|
E-Z-Paque powder, for suspension 960 mg/g (NDA)
|
E-Z-EM Canada Inc |
barium sulfate |
D02052
|
|
Amlodipine Besylate tablet 2.5 mg (ANDA)
|
Bryant Ranch Prepack |
Amlodipine besylate |
D00615
|
|
Fetroja injection, powder, for solution 1 g0mL (NDA)
|
Shionogi Inc. |
Cefiderocol sulfate tosylate |
D11013
|
|
Dexamethasone Sodium Phosphate injection 10 mg/mL (ANDA)
|
Cardinal Health 107, LLC |
Dexamethasone Sodium Phosphate |
D00975
|
|
CLOZAPINE tablet 100 mg (ANDA)
|
Cardinal Health 107, LLC |
CLOZAPINE |
D00283
|
|
Fluoxetine capsule 10 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc. |
Fluoxetine Hydrochloride |
D00823
|
LAMOTRIGINE tablet 25 mg (ANDA)
LAMOTRIGINE tablet 50 mg (ANDA)
LAMOTRIGINE tablet 200 mg (ANDA)
LAMOTRIGINE tablet 100 mg (ANDA)
|
Sun Pharmaceutical Industries, Inc. |
lamotrigine |
D00354
|
|
Metaxalone tablet 400 mg (ANDA)
|
Highmark Pharma LLC |
Metaxalone |
D00773
|
|
ERBITUX solution 2 mg/mL (BLA)
|
ImClone LLC |
cetuximab |
D03455
|
|
Bupivacaine Hydrochloride injection, solution 2.5 mg/mL (ANDA)
|
Cardinal Health 107, LLC |
BUPIVACAINE HYDROCHLORIDE |
D01450
|
|
Diazepam injection, solution 10 mg/2mL (ANDA)
|
Dr. Reddy's Laboratories Inc |
DIAZEPAM |
D00293
|
|
Bumetanide tablet 1 mg (ANDA)
|
Cardinal Health 107, LLC |
Bumetanide |
D00247
|
Methylprednisolone Acetate injection, suspension 40 mg/mL (ANDA)
Methylprednisolone Acetate injection, suspension 80 mg/mL (ANDA)
|
Eugia US LLC |
Methylprednisolone Acetate |
D00979
|
|
Furosemide tablet 40 mg (ANDA)
|
Preferred Pharmaceuticals, Inc. |
Furosemide |
D00331
|
|
E-Z-HD powder, for suspension 980 mg/g (NDA)
|
E-Z-EM Canada Inc |
barium sulfate |
D02052
|
Fenofibrate capsule 67 mg (ANDA)
Fenofibrate capsule 134 mg (ANDA)
Fenofibrate capsule 200 mg (ANDA)
|
Bostal LLC |
FENOFIBRATE |
D00565
|
|
divalproex sodium capsule, coated pellets 125 mg (ANDA)
|
First Nation Group, LLC |
divalproex sodium |
D00304
|
Carbidopa and Levodopa tablet, extended release 25 mg (ANDA)
Carbidopa and Levodopa tablet, extended release 50 mg (ANDA)
|
Alembic Pharmaceuticals Inc. |
Carbidopa and Levodopa |
D00253
|
|
Ciprofloxacin tablet, film coated 500 mg (ANDA)
|
Asclemed USA, Inc. |
Ciprofloxacin Hydrochloride |
D02216
|
|
NEBIVOLOL tablet 5 mg (ANDA)
|
REMEDYREPACK INC. |
NEBIVOLOL |
D06622
|
|
divalproex sodium capsule, coated pellets 125 mg (ANDA)
|
Lifestar Pharma LLC |
divalproex sodium |
D00304
|
CARBAMAZEPINE ER tablet, extended release 100 mg (ANDA)
CARBAMAZEPINE ER tablet, extended release 200 mg (ANDA)
CARBAMAZEPINE ER tablet, extended release 400 mg (ANDA)
|
Bostal LLC |
carbamazepine |
D00252
|
|
Indomethacin capsule 25 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc. |
Indomethacin |
D00141
|
|
Albuterol Sulfate solution 2.5 mg/3mL (ANDA)
|
Ritedose Pharmaceuticals, LLC |
Albuterol Sulfate |
D00683
|
Diltiazem Hydrochloride capsule, extended release 240 mg (ANDA)
Diltiazem Hydrochloride capsule, extended release 120 mg (ANDA)
Diltiazem Hydrochloride capsule, extended release 180 mg (ANDA)
|
Cardinal Health 107, LLC |
Diltiazem hydrochloride |
D00616
|
|
Clopidogrel tablet, film coated 75 mg (ANDA)
|
Cardinal Health 107, LLC |
Clopidogrel Bisulfate |
D00769
|
Methylphenidate Hydrochloride tablet, extended release 18 mg (ANDA)
Methylphenidate Hydrochloride tablet, extended release 27 mg (ANDA)
Methylphenidate Hydrochloride tablet, extended release 36 mg (ANDA)
Methylphenidate Hydrochloride tablet, extended release 54 mg (ANDA)
Methylphenidate Hydrochloride tablet, extended release 72 mg (ANDA)
|
Trigen Laboratories, LLC |
Methylphenidate hydrochloride |
D01296
|
|
LAMOTRIGINE tablet 25 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc. |
LAMOTRIGINE |
D00354
|
|
Montelukast Sodium tablet, chewable 4 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc. |
Montelukast Sodium |
D00529
|
|
Furosemide tablet 20 mg (ANDA)
|
Preferred Pharmaceuticals Inc. |
Furosemide |
D00331
|
WELLBUTRIN SR tablet, film coated 100 mg (NDA)
WELLBUTRIN SR tablet, film coated 150 mg (NDA)
WELLBUTRIN SR tablet, film coated 200 mg (NDA)
|
GlaxoSmithKline LLC |
bupropion hydrochloride |
D00817
|
|
Sodium phenylbutyrate tablet 500 mg (ANDA)
|
Zydus Pharmaceuticals USA Inc. |
Sodium phenylbutyrate |
D05868
|
|
Albuterol Sulfate solution 2.5 mg/3mL (ANDA)
|
Cardinal Health 107, LLC |
Albuterol Sulfate |
D00683
|
|
Gabapentin tablet, film coated 800 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc. |
Gabapentin |
D00332
|
|
Fluoxetine capsule 20 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc. |
Fluoxetine Hydrochloride |
D00823
|
|
Varibar Honey suspension 400 mg/mL (NDA)
|
E-Z-EM Canada Inc |
barium sulfate |
D02052
|
Albuterol Sulfate Inhalation Solution solution 1.25 mg/3mL (ANDA)
Albuterol Sulfate Inhalation Solution solution .63 mg/3mL (ANDA)
|
Ritedose Pharmaceuticals, LLC |
Albuterol Sulfate |
D00683
|