| Product |
Company |
Generic name |
KEGG DRUG |
|
Theophylline Anhydrous tablet, extended release 400 mg (ANDA)
|
Rhodes Pharmaceuticals L.P. |
Theophylline |
D00371
|
|
Mesalamine suppository 1000 mg (ANDA)
|
Rising Pharma Holdings, Inc. |
Mesalamine |
D00377
|
Heparin Sodium injection, solution 10000 [USP'U]/mL (NDA)
Heparin Sodium injection, solution 1000 [USP'U]/mL (NDA)
Heparin Sodium injection, solution 20000 [USP'U]/mL (NDA)
Heparin Sodium injection, solution 5000 [USP'U]/mL (NDA)
Heparin Sodium injection, solution 5000 [USP'U]/.5mL (NDA)
|
Fresenius Kabi USA, LLC |
HEPARIN SODIUM |
D02112
|
|
Fidaxomicin tablet, film coated 200 mg (ANDA)
|
Teva Pharmaceuticals, Inc. |
fidaxomicin |
D09394
|
Heparin Sodium injection, solution 5000 [USP'U]/mL (NDA)
Heparin Sodium injection, solution 1000 [USP'U]/mL (NDA)
|
Fresenius Kabi USA, LLC |
HEPARIN SODIUM |
D02112
|
|
OXYGEN gas 999 L000L (NDA)
|
Norco, Inc. |
OXYGEN |
D00003
|
XENPOZYME injection, powder, lyophilized, for solution 20 mg/5.1mL (BLA)
XENPOZYME injection, powder, lyophilized, for solution 4 mg.1mL (BLA)
|
Genzyme Corporation |
olipudase alfa-rpcp |
D10820
|
CINACALCET tablet 30 mg (ANDA)
CINACALCET tablet 60 mg (ANDA)
CINACALCET tablet 90 mg (ANDA)
|
Cipla USA Inc. |
CINACALCET |
D03505
|
|
Amoxicillin for suspension 400 mg/5mL (NDA AUTHORIZED GENERIC)
|
ASCLEMED USA INC. |
Amoxicillin |
D00229
|
|
Diltiazem Hydrochloride capsule, extended release 240 mg (ANDA)
|
A-S Medication Solutions |
Diltiazem Hydrochloride |
D00616
|
|
MESNEX injection, solution 100 mg/mL (NDA)
|
Bamboo US Bidco LCC |
mesna |
D01459
|
Valacyclovir tablet, film coated 500 mg (ANDA)
Valacyclovir tablet, film coated 1 g (ANDA)
|
SUN PHARMACEUTICAL INDUSTRIES, INC. |
Valacyclovir |
D00398
|
EMFLAZA tablet 6 mg (NDA)
EMFLAZA tablet 18 mg (NDA)
EMFLAZA tablet 30 mg (NDA)
EMFLAZA tablet 36 mg (NDA)
EMFLAZA suspension 22.75 mg/mL (NDA)
|
PTC Therapeutics, Inc. |
deflazacort |
D03671
|
Alprazolam tablet, extended release .5 mg (ANDA)
Alprazolam tablet, extended release 1 mg (ANDA)
Alprazolam tablet, extended release 2 mg (ANDA)
Alprazolam tablet, extended release 3 mg (ANDA)
|
Aurobindo Pharma Limited |
Alprazolam |
D00225
|
|
Doxycycline Hyclate tablet, film coated 50 mg (ANDA)
|
JG Pharma Inc. |
Doxycycline Hyclate |
D02129
|
|
Linezolid tablet, film coated 600 mg (ANDA)
|
REMEDYREPACK INC. |
Linezolid |
D00947
|
|
drospirenone and ethinyl estradiol kit (ANDA)
|
Glenmark Pharmaceuticals Inc., USA |
drospirenone and ethinyl estradiol |
D09741
|
Atomoxetine capsule 10 mg (ANDA)
Atomoxetine capsule 18 mg (ANDA)
Atomoxetine capsule 25 mg (ANDA)
Atomoxetine capsule 40 mg (ANDA)
Atomoxetine capsule 60 mg (ANDA)
Atomoxetine capsule 80 mg (ANDA)
Atomoxetine capsule 100 mg (ANDA)
|
Aurobindo Pharma Limited |
Atomoxetine |
D02574
|
olmesartan medoxomil tablet, film coated 5 mg (ANDA)
olmesartan medoxomil tablet, film coated 20 mg (ANDA)
olmesartan medoxomil tablet, film coated 40 mg (ANDA)
|
Golden State Medical Supply, Inc. |
olmesartan medoxomil |
D01204
|
Bupropion Hydrochloride (XL) tablet, extended release 150 mg (ANDA)
Bupropion Hydrochloride (XL) tablet, extended release 300 mg (ANDA)
|
Golden State Medical Supply, Inc. |
bupropion hydrochloride |
D00817
|
|
Dalfampridine tablet, film coated, extended release 10 mg (ANDA)
|
Golden State Medical Supply, Inc. |
Dalfampridine |
D04127
|
|
Tranexamic Acid injection, solution 100 mg/mL (ANDA)
|
Amneal Pharmaceuticals LLC |
Tranexamic Acid |
D01136
|
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate tablet 1.25 mg (ANDA)
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate tablet 1.875 mg (ANDA)
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate tablet 2.5 mg (ANDA)
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate tablet 3.125 mg (ANDA)
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate tablet 3.75 mg (ANDA)
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate tablet 5 mg (ANDA)
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate tablet 7.5 mg (ANDA)
|
Aurolife Pharma, LLC |
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate |
D11624
|
|
Promethazine Hydrochloride and Dextromethorphan Hydrobromide solution 15 mg/5mL (ANDA)
|
Cranbury Pharmaceuticals, LLC |
Promethazine Hydrochloride and Dextromethorphan Hydrobromide |
D11854
|
|
Terbinafine Hydrochloride tablet 250 mg (ANDA)
|
Golden State Medical Supply, Inc. |
Terbinafine Hydrochloride |
D02219
|
|
GABAPENTIN solution 250 mg/5mL (ANDA)
|
Camber Pharmaceuticals, Inc. |
GABAPENTIN |
D00332
|
SPIRONOLACTONE tablet 25 mg (ANDA)
SPIRONOLACTONE tablet, film coated 50 mg (ANDA)
SPIRONOLACTONE tablet, film coated 100 mg (ANDA)
|
Sun Pharmaceutical Industries, Inc. |
SPIRONOLACTONE |
D00443
|
|
Oseltamivir phosphate for suspension 6 mg/mL (ANDA)
|
Ajanta Pharma USA Inc. |
Oseltamivir phosphate |
D00900
|
Meropenem injection, powder, for solution 500 mg/20mL (ANDA)
Meropenem injection, powder, for solution 1 g/30mL (ANDA)
|
BluePoint Laboratories |
Meropenem |
D02222
|
Captopril tablet 12.5 mg (ANDA)
Captopril tablet 25 mg (ANDA)
Captopril tablet 50 mg (ANDA)
Captopril tablet 100 mg (ANDA)
|
Golden State Medical Supply, Inc. |
Captopril |
D00251
|
Alprazolam tablet .25 mg (ANDA)
Alprazolam tablet .5 mg (ANDA)
Alprazolam tablet 1 mg (ANDA)
Alprazolam tablet 2 mg (ANDA)
|
Aurobindo Pharma Limited |
Alprazolam |
D00225
|
|
promethazine hydrochloride syrup 6.25 mg/5mL (ANDA)
|
Cranbury Pharmaceuticals, LLC |
promethazine hydrochloride |
D00480
|
Cilostazol tablet 50 mg (ANDA)
Cilostazol tablet 100 mg (ANDA)
|
Slate Run Pharmaceuticals, LLC |
cilostazol |
D01896
|
|
Argatroban injection, solution 100 mg/mL (NDA)
|
Fresenius Kabi USA, LLC |
Argatroban |
D00181
|
pioglitazone and glimepiride tablet 2 mg (NDA AUTHORIZED GENERIC)
pioglitazone and glimepiride tablet 4 mg (NDA AUTHORIZED GENERIC)
|
Prasco Laboratories |
pioglitazone and glimepiride |
D09848
|
|
Herceptin Hylecta injection, solution 10000 U/5mL (BLA)
|
Genentech, Inc. |
Trastuzumab and hyaluronidase-oysk |
D11560
|
clindamycin phosphate lotion 10 mg/mL (NDA AUTHORIZED GENERIC)
clindamycin phosphate gel 10 mg/g (NDA AUTHORIZED GENERIC)
|
Mylan Pharmaceuticals Inc. |
clindamycin phosphate |
D01073
|
|
glyburide-metformin hydrochloride tablet 2.5 mg (ANDA)
|
A-S Medication Solutions |
glyburide-metformin hydrochloride |
D10266
|
|
Cromolyn Sodium Inhalation Solution solution 20 mg/2mL (ANDA)
|
Ritedose Pharmaceuticals, LLC |
Cromolyn Sodium Inhalation Solution |
D00526
|
Divalproex Sodium tablet, delayed release 125 mg (ANDA)
Divalproex Sodium tablet, delayed release 250 mg (ANDA)
Divalproex Sodium tablet, delayed release 500 mg (ANDA)
|
Upsher-Smith Laboratories, LLC |
Divalproex Sodium |
D00304
|