| Product |
Company |
Generic name |
KEGG DRUG |
|
LUXTURNA kit (BLA)
|
Spark Therapeutics, Inc. |
voretigene neparvovec-rzyl |
D11008
|
Linzess capsule, gelatin coated 145 ug (NDA)
Linzess capsule, gelatin coated 290 ug (NDA)
Linzess capsule, gelatin coated 72 ug (NDA)
|
Allergan, Inc. |
linaclotide |
D09355
|
|
Lidocaine patch 700 mg (ANDA)
|
AvKARE |
Lidocaine |
D00358
|
|
METOPROLOL TARTRATE tablet 50 mg (ANDA)
|
Proficient Rx LP |
METOPROLOL TARTRATE |
D00601
|
|
Oxybutynin Chloride tablet 5 mg (ANDA)
|
Preferred Pharmaceuticals Inc. |
Oxybutynin Chloride |
D00722
|
Rosuvastatin tablet, film coated 10 mg (ANDA)
Rosuvastatin tablet, film coated 20 mg (ANDA)
|
Cardinal Health 107, LLC |
Rosuvastatin |
D01915
|
|
Sotalol Hydrochloride tablet 120 mg (ANDA)
|
Proficient Rx LP |
Sotalol Hydrochloride |
D01026
|
|
Doxycycline tablet 100 mg (ANDA)
|
Proficient Rx LP |
Doxycycline |
D00307
|
|
Carbidopa and levodopa tablet 25 mg (ANDA)
|
AvKARE |
Carbidopa and levodopa |
D00253
|
|
EPIOXA CROSS-LINKING kit (NDA)
|
Glaukos Corporation |
riboflavin 5-phosphate ophthalmic |
D05725
|
Buspirone Hydrochloride tablet 5 mg (ANDA)
Buspirone Hydrochloride tablet 10 mg (ANDA)
Buspirone Hydrochloride tablet 15 mg (ANDA)
Buspirone Hydrochloride tablet 30 mg (ANDA)
|
Proficient Rx LP |
buspirone hydrochloride |
D00702
|
|
Buspirone Hydrochloride tablet 15 mg (ANDA)
|
Preferred Pharmaceuticals Inc. |
Buspirone Hydrochloride |
D00702
|
|
Entecavir tablet .5 mg (ANDA)
|
Carlsbad Technology, Inc. |
Entecavir |
D04008
|
Midodrine Hydrochloride tablet 2.5 mg (ANDA)
Midodrine Hydrochloride tablet 5 mg (ANDA)
Midodrine Hydrochloride tablet 10 mg (ANDA)
|
AvKARE |
Midodrine Hydrochloride |
D01307
|
Meloxicam tablet 7.5 mg (ANDA)
Meloxicam tablet 15 mg (ANDA)
|
Carlsbad Technology, Inc. |
Meloxicam |
D00969
|
LAMOTRIGINE tablet, orally disintegrating 25 mg (ANDA)
LAMOTRIGINE tablet, orally disintegrating 50 mg (ANDA)
LAMOTRIGINE tablet, orally disintegrating 100 mg (ANDA)
LAMOTRIGINE tablet, orally disintegrating 200 mg (ANDA)
|
Torrent Pharmaceuticals Limited |
LAMOTRIGINE |
D00354
|
|
Mesalamine tablet, delayed release 800 mg (ANDA)
|
AvKARE |
Mesalamine |
D00377
|
|
ACETAMINOPHEN AND CODEINE PHOSPHATE tablet 300 mg (ANDA)
|
Preferred Pharmaceuticals Inc. |
acetaminophen and codeine phosphate |
D02146
|
Timolol Maleate solution, gel forming / drops 2.5 mg/mL (ANDA)
Timolol Maleate solution, gel forming / drops 5 mg/mL (ANDA)
|
Sagent Pharmaceuticals |
Timolol Maleate |
D00603
|
Solu-Medrol injection, powder, for solution 125 mg/2mL (NDA)
Solu-Medrol injection, powder, for solution 40 mg/mL (NDA)
|
Cardinal Health 107, LLC |
methylprednisolone sodium succinate |
D00751
|
Memantine Hydrochloride tablet, film coated 5 mg (ANDA)
Memantine Hydrochloride tablet, film coated 10 mg (ANDA)
|
Carlsbad Technology, Inc. |
Memantine Hydrochloride |
D04905
|
Levothyroxine Sodium tablet .025 mg (ANDA)
Levothyroxine Sodium tablet .05 mg (ANDA)
Levothyroxine Sodium tablet .075 mg (ANDA)
Levothyroxine Sodium tablet .1 mg (ANDA)
Levothyroxine Sodium tablet .125 mg (ANDA)
Levothyroxine Sodium tablet .15 mg (ANDA)
Levothyroxine Sodium tablet .088 mg (ANDA)
|
Cardinal Health 107, LLC |
Levothyroxine Sodium |
D01010
|
metformin hydrochloride tablet, film coated, extended release 500 mg (ANDA)
metformin hydrochloride tablet, film coated, extended release 1000 mg (ANDA)
|
EPIC PHARMA, LLC |
metformin hydrochloride tablets |
D00944
|
|
Methocarbamol tablet, film coated 750 mg (ANDA)
|
NuCare Pharmaceuticals,Inc. |
Methocarbamol |
D00402
|
|
Metformin hydrochloride tablet, extended release 500 mg (ANDA)
|
Proficient Rx LP |
Metformin hydrochloride |
D00944
|
|
Olanzapine tablet 2.5 mg (ANDA)
|
Coupler LLC |
Olanzapine |
D00454
|
|
Hydroxyzine Hydrochloride solution 10 mg/5mL (ANDA)
|
ANI Pharmaceuticals, Inc. |
Hydroxyzine Hydrochloride |
D00672
|
Furosemide tablet 20 mg (NDA)
Furosemide tablet 40 mg (NDA)
Furosemide tablet 80 mg (NDA)
|
Granulation Technology, Inc. |
FUROSEMIDE |
D00331
|
|
Pregabalin capsule 100 mg (ANDA)
|
Coupler LLC |
Pregabalin |
D02716
|
Carbamazepine ER tablet, extended release 100 mg (ANDA)
Carbamazepine ER tablet, extended release 200 mg (ANDA)
Carbamazepine ER tablet, extended release 400 mg (ANDA)
|
Epic Pharma, LLC |
Carbamazepine |
D00252
|
|
COLCHICINE capsule .6 mg (ANDA)
|
Coupler LLC |
COLCHICINE |
D00570
|
|
Diclofenac Sodium tablet, delayed release 50 mg (ANDA)
|
A-S Medication Solutions |
Diclofenac Sodium |
D00904
|
POTASSIUM CHLORIDE solution 1.5 g5mL (ANDA)
POTASSIUM CHLORIDE solution 3 g5mL (ANDA)
|
Saptalis Pharmaceuticals, LLC |
POTASSIUM CHLORIDE ORAL |
D02060
|
|
Halog cream 1 mg/g (NDA)
|
Genus Lifesciences Inc. |
Halcinonide Cream |
D01308
|
|
Deferasirox tablet 360 mg (ANDA)
|
AvKARE |
Deferasirox |
D03669
|
|
glyburide-metformin hydrochloride tablet 5 mg (ANDA)
|
NuCare Pharmaceuticals, Inc. |
glyburide-metformin hydrochloride |
D10266
|
|
SERTRALINE HYDROCHLORIDE tablet 25 mg (ANDA)
|
NuCare Pharmaceuticals, Inc. |
sertraline hydrochloride |
D00825
|
|
Prazosin Hydrochloride capsule 2 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC |
Prazosin Hydrochloride |
D00609
|
|
Prazosin Hydrochloride capsule 2 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC |
Prazosin Hydrochloride |
D00609
|
|
Sacubitril and Valsartan tablet 24 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC |
Sacubitril and Valsartan |
D10226
|