| Product |
Company |
Generic name |
KEGG DRUG |
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
|
DAPAGLIFLOZIN tablet, film coated 5 mg (ANDA)
DAPAGLIFLOZIN tablet, film coated 10 mg (ANDA)
|
Biocon Pharma Inc. |
DAPAGLIFLOZIN |
|
|
Warfarin Sodium tablet 3 mg (ANDA)
|
REMEDYREPACK INC. |
Warfarin |
D00564
|
|
Carbamazepine tablet 200 mg (ANDA)
|
REMEDYREPACK INC. |
Carbamazepine |
D00252
|
|
OTARMENI injection, solution 30000000000000 {GC}/mL (BLA)
|
Regeneron Pharmaceuticals, Inc. |
lunsotogene parvec |
|
|
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
|
|
Silodosin capsule 8 mg (ANDA)
|
Bryant Ranch Prepack |
Silodosin |
D01965
|
|
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE solution/ drops 20 mg/mL (ANDA)
|
Micro Labs Limited |
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE PRESERVATIVE FREE |
D08493
|
|
Cyanocobalamin injection, solution 1000 ug/mL (ANDA)
|
Lifestar Pharma LLC |
Cyanocobalamin |
D00166
|
|
Topiramate tablet 200 mg (ANDA)
|
REMEDYREPACK INC. |
Topiramate |
D00537
|
|
Acyclovir capsule 200 mg (ANDA)
|
Modavar Pharmaceuticals LLC |
Acyclovir |
D00222
|
Heparin Sodium injection, solution 5000 [USP'U]/mL (ANDA)
Heparin Sodium injection, solution 10000 [USP'U]/mL (ANDA)
|
Hospira, Inc. |
HEPARIN SODIUM |
D02112
|
|
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
|
|
DAPTACEL injection, suspension 5 ug/.5mL (BLA)
|
Sanofi Vaccines US Inc. |
corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated), clostridium tetani toxoid antigen (formaldehyde inactivated), bordetella pertussis toxoid antigen (glutaraldehyde inactivated), bordetella pertussis filamentous hemagglutinin antigen (formaldehyde inactivated), bordetella pertussis pertactin antigen, and bordetella pertussis fimbriae 2/3 antigen |
D05356
|
|
Divalproex sodium capsule, delayed release 125 mg (ANDA)
|
Cardinal Health 107, LLC |
Divalproex sodium |
D00304
|
|
Acclean Chlorhexidine Gluconate 0.12% Oral Rinse liquid 1.2 mg/mL (ANDA)
|
Henry Schein, Inc. |
Chlorhexidine Gluconate 0.12% Oral Rinse |
D00858
|
|
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
|