| Product |
Company |
Generic name |
KEGG DRUG |
|
XTORO suspension 3 mg/mL (NDA)
|
Fonseca Biosciences, LLC |
finafloxacin |
D10575
|
|
NADOLOL tablet 80 mg (ANDA)
|
Bryant Ranch Prepack |
NADOLOL |
D00432
|
|
Bimatoprost solution/ drops .1 mg/mL (ANDA)
|
First Nation Group, LLC |
Bimatoprost |
D02724
|
TENORMIN tablet 25 mg (NDA)
TENORMIN tablet 50 mg (NDA)
TENORMIN tablet 100 mg (NDA)
|
Upsher-Smith Laboratories, LLC |
Atenolol |
D00235
|
|
Verapamil Hydrochloride injection, solution 2.5 mg/mL (ANDA)
|
Hospira, Inc. |
VERAPAMIL HYDROCHLORIDE |
D00619
|
mycophenolate mofetil capsule 250 mg (ANDA)
mycophenolate mofetil tablet 500 mg (ANDA)
|
Accord Healthcare Inc. |
mycophenolate mofetil |
D00752
|
|
Levorphanol Tartrate tablet 2 mg (ANDA)
|
SpecGx LLC |
Levorphanol Tartrate |
D00841
|
enoxaparin sodium injection 30 mg/.3mL (ANDA)
enoxaparin sodium injection 40 mg/.4mL (ANDA)
enoxaparin sodium injection 60 mg/.6mL (ANDA)
enoxaparin sodium injection 80 mg/.8mL (ANDA)
enoxaparin sodium injection 100 mg/mL (ANDA)
enoxaparin sodium injection 120 mg/.8mL (ANDA)
enoxaparin sodium injection 150 mg/mL (ANDA)
|
Hebei Changshan Biochemical Pharmaceutical Co., Ltd. |
enoxaparin sodium |
D03674
|
METHADOSE concentrate 10 mg/mL (NDA)
METHADOSE SUGAR-FREE concentrate 10 mg/mL (NDA)
|
SpecGx LLC |
methadone hydrochloride |
D02102
|
|
divalproex sodium capsule, coated pellets 125 mg (ANDA)
|
REMEDYREPACK INC. |
divalproex sodium |
D00304
|
VANCOMYCIN HYDROCHLORIDE capsule 125 mg (ANDA)
VANCOMYCIN HYDROCHLORIDE capsule 250 mg (ANDA)
|
PAI Holdings, LLC dba PAI Pharma |
VANCOMYCIN HYDROCHLORIDE |
D00926
|
|
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE solution/ drops 20 mg/mL (ANDA)
|
Micro Labs Limited |
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE PRESERVATIVE FREE |
D08493
|
|
Acyclovir capsule 200 mg (ANDA)
|
Modavar Pharmaceuticals LLC |
Acyclovir |
D00222
|
|
Sertraline Hydrochloride tablet, film coated 50 mg (ANDA)
|
REMEDYREPACK INC. |
Sertraline Hydrochloride |
D00825
|
|
Divalproex Sodium tablet, delayed release 500 mg (ANDA)
|
REMEDYREPACK INC. |
Divalproex Sodium |
D00304
|
|
Fingolimod capsule .5 mg (ANDA)
|
Alembic Pharmaceuticals Limited |
Fingolimod |
D04187
|
|
CLINDAMYCIN PHOSPHATE gel 10 mg/g (ANDA)
|
Aurobindo Pharma Limited |
CLINDAMYCIN PHOSPHATE |
D01073
|
|
Hetastarch in Sodium Chloride injection, solution 6 g00mL (ANDA)
|
Hospira, Inc. |
HETASTARCH |
D03335
|
|
Bortezomib injection, powder, lyophilized, for solution 3.5 mg (ANDA)
|
Avenacy, LLC |
bortezomib |
D03150
|
|
BUPROPION HCl ER (XL) tablet, extended release 450 mg (NDA)
|
Lifestar Pharma LLC |
BUPROPION HCl ER |
D00817
|
Potassium chloride tablet, film coated, extended release 600 mg (ANDA)
Potassium chloride tablet, film coated, extended release 750 mg (ANDA)
|
Macleods Pharmaceuticals Limited |
Potassium chloride |
D02060
|
Metoclopramide tablet 5 mg (ANDA)
Metoclopramide tablet 10 mg (ANDA)
|
Teva Pharmaceuticals USA, Inc. |
Metoclopramide |
D05008
|
|
Prednisone tablet 1 mg (ANDA)
|
Bryant Ranch Prepack |
Prednisone |
D00473
|
METHADONE HYDROCHLORIDE tablet 5 mg (ANDA)
METHADONE HYDROCHLORIDE tablet 10 mg (ANDA)
|
SpecGx LLC |
METHADONE HYDROCHLORIDE |
D02102
|
|
Adalimumab-ryvk kit (BLA)
|
Teva Pharmaceuticals USA, Inc. |
adalimumab-ryvk |
D02597
|
Methylprednisolone Sodium Succinate injection, powder, for solution 40 mg (ANDA)
Methylprednisolone Sodium Succinate injection, powder, for solution 125 mg (ANDA)
|
Hikma Pharmaceuticals USA Inc. |
Methylprednisolone Sodium Succinate |
D00751
|
|
Amiodarone Hydrochloride tablet 200 mg (ANDA)
|
Cardinal Health 107, LLC |
Amiodarone Hydrochloride |
D00636
|
Clonidine Transdermal System USP, 0.1 mg/day patch .1 mg/d (NDA AUTHORIZED GENERIC)
Clonidine Transdermal System USP, 0.2 mg/day patch .2 mg/d (NDA AUTHORIZED GENERIC)
Clonidine Transdermal System USP, 0.3 mg/day patch .3 mg/d (NDA AUTHORIZED GENERIC)
|
TruPharma, LLC |
clonidine transdermal system |
D00281
|
|
Nitrogen gas 992 mL/L (NDA)
|
WELDERS SUPPLY COMPANY OF LOUISVILLE, INC. |
Nitrogen |
D00083
|
|
Oxygen gas 992 mL/L (NDA)
|
WELDERS SUPPLY COMPANY OF LOUISVILLE, INC. |
Oxygen |
D00003
|
|
ATORVASTATIN CALCIUM tablet, film coated 40 mg (ANDA)
|
Cardinal Health 107, LLC |
ATORVASTATIN CALCIUM |
D11095
|
amlodipine besylate and olmesartan medoxomil tablet, film coated 5 mg (NDA)
amlodipine besylate and olmesartan medoxomil tablet, film coated 10 mg (NDA)
|
Golden State Medical Supply, Inc. |
amlodipine besylate and olmesartan medoxomil |
D10285
|
Buprenorphine patch, extended release 5 ug/h (ANDA)
Buprenorphine patch, extended release 7.5 ug/h (ANDA)
Buprenorphine patch, extended release 10 ug/h (ANDA)
Buprenorphine patch, extended release 15 ug/h (ANDA)
Buprenorphine patch, extended release 20 ug/h (ANDA)
|
INGENUS PHARMACEUTICALS, LLC |
Buprenorphine |
D07132
|
|
TENIVAC injection, suspension 5 [Lf]/.5mL (BLA)
|
Sanofi Vaccines US Inc. |
CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) and CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) |
D05256
|
Buprenorphine patch, extended release 5 ug/h (ANDA)
Buprenorphine patch, extended release 7.5 ug/h (ANDA)
Buprenorphine patch, extended release 10 ug/h (ANDA)
Buprenorphine patch, extended release 15 ug/h (ANDA)
Buprenorphine patch, extended release 20 ug/h (ANDA)
|
Aveva Drug Delivery Systems Inc. |
Buprenorphine |
D07132
|
|
Meloxicam tablet 7.5 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc. |
Meloxicam |
D00969
|
Allopurinol tablet 100 mg (ANDA)
Allopurinol tablet 300 mg (ANDA)
|
Cardinal Health 107, LLC |
Allopurinol |
D00224
|
PALIPERIDONE tablet, extended release 1.5 mg (ANDA)
PALIPERIDONE tablet, extended release 3 mg (ANDA)
PALIPERIDONE tablet, extended release 6 mg (ANDA)
PALIPERIDONE tablet, extended release 9 mg (ANDA)
|
Camber Pharmaceuticals, Inc |
paliperidone |
D05339
|
|
Chlorhexidine Gluconate rinse 1.2 mg/mL (ANDA)
|
Benco Dental |
Chlorhexidine Gluconate |
D00858
|
|
Dipyridamole tablet, film coated 50 mg (ANDA)
|
REMEDYREPACK INC. |
Dipyridamole |
D00302
|