| Product |
Company |
Generic name |
KEGG DRUG |
Ampicillin sodium injection, powder, for solution 2 g (ANDA)
Ampicillin injection, powder, for solution 1 g (ANDA)
|
Armas Pharmaceuticals Inc. |
Ampicillin |
D02119
|
|
Varenicline tablet, film coated 1 mg (ANDA)
|
American Health Packaging |
Varenicline tartrate |
D06282
|
KETOROLAC TROMETHAMINE injection 15 mg/mL (ANDA)
KETOROLAC TROMETHAMINE injection 30 mg/mL (ANDA)
KETOROLAC TROMETHAMINE injection 60 mg/2mL (ANDA)
|
Onesource Specialty Pharma Limited |
KETOROLAC TROMETHAMINE |
D00813
|
KETOROLAC TROMETHAMINE injection 15 mg/mL (ANDA)
KETOROLAC TROMETHAMINE injection 30 mg/mL (ANDA)
KETOROLAC TROMETHAMINE injection 60 mg/2mL (ANDA)
|
Onesource Specialty Pharma Limited |
KETOROLAC TROMETHAMINE |
D00813
|
Deflazacort tablet 6 mg (ANDA)
Deflazacort tablet 18 mg (ANDA)
Deflazacort tablet 30 mg (ANDA)
Deflazacort tablet 36 mg (ANDA)
|
AvKARE |
Deflazacort |
D03671
|
|
Atomoxetine capsule 25 mg (ANDA)
|
A-S Medication Solutions |
Atomoxetine |
D02574
|
|
Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate capsule 300 mg (ANDA)
|
Actavis Pharma, Inc. |
Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate |
D11851
|
|
Fluorouracil injection, solution 50 mg/mL (ANDA)
|
Alembic Pharmaceuticals Inc. |
Fluorouracil |
D00584
|
|
Norgestimate and ethinyl estradiol kit (ANDA)
|
Lupin Pharmaceuticals, Inc. |
Norgestimate and ethinyl estradiol |
D10590
|
|
Duloxetine capsule, delayed release 20 mg (ANDA)
|
A-S Medication Solutions |
Duloxetine |
D01179
|
Cephalexin powder, for suspension 125 mg/5mL (ANDA)
Cephalexin powder, for suspension 250 mg/5mL (ANDA)
|
Chartwell RX, LLC |
Cephalexin |
D00906
|
TIZANIDINE HYDROCHLORIDE capsule 2 mg (ANDA)
TIZANIDINE HYDROCHLORIDE capsule 4 mg (ANDA)
TIZANIDINE HYDROCHLORIDE capsule 6 mg (ANDA)
|
Ingenus Pharmaceuticals, LLC |
tizanidine hydrochloride |
D00776
|
Telmisartan tablet 20 mg (ANDA)
Telmisartan tablet 40 mg (ANDA)
Telmisartan tablet 80 mg (ANDA)
|
NorthStar RxLLC |
Telmisartan |
D00627
|
|
CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE capsule 5 mg (ANDA)
|
Chartwell RX, LLC |
Chlordiazepoxide Hydrochloride and Clidinium Bromide |
D10247
|
AMPICILLIN injection, powder, for solution 1 g (ANDA)
AMPICILLIN injection, powder, for solution 2 g (ANDA)
|
Civica, Inc. |
Ampicillin |
D02119
|
|
Neomycin and Polymyxin B Sulfates solution 40 mg/mL (ANDA)
|
XGen Pharmaceuticals DJB, Inc. |
Neomycin and Polymyxin B Sulfates |
D11096
|
|
Carisoprodol tablet 350 mg (ANDA)
|
Chartwell RX, LLC |
Carisoprodol |
D00768
|
|
HUMATROPE kit (BLA)
|
Eli Lilly and Company |
Somatropin |
D02691
|
Celecoxib capsule 100 mg (ANDA)
Celecoxib capsule 200 mg (ANDA)
Celecoxib capsule 400 mg (ANDA)
|
Chartwell RX, LLC |
Celecoxib |
D00567
|
|
Tadalafil tablet 20 mg (ANDA)
|
REMEDYREPACK INC. |
Tadalafil |
D02008
|
|
TRI-LO-MARZIA kit (ANDA)
|
Lupin Pharmaceuticals, Inc. |
norgestimate and ethinyl estradiol |
D10590
|
|
Fioricet capsule 300 mg (ANDA)
|
Actavis Pharma, Inc. |
Butalbital, Acetaminophen, and Caffeine |
D11850
|
|
Norgestimate and Ethinyl Estradiol kit (ANDA)
|
Lupin Pharmaceuticals, Inc. |
Norgestimate and Ethinyl Estradiol |
D10590
|
|
Desoximetasone ointment 2.5 mg/g (ANDA)
|
Actavis Pharma, Inc. |
Desoximetasone |
D03697
|
|
ARSENIC TRIOXIDE injection 1 mg/mL (ANDA)
|
Ingenus Pharmaceuticals, LLC |
arsenic trioxide |
D02106
|
|
Cephalexin capsule 250 mg (ANDA)
|
Chartwell RX, LLC |
Cephalexin |
D00906
|
|
Spironolactone and Hydrochlorothiazide tablet 25 mg (ANDA)
|
Sun Pharmaceutical Industries, Inc. |
Spironolactone and Hydrochlorothiazide |
D10270
|
Amiodarone Hydrochloride tablet 200 mg (ANDA)
Amiodarone Hydrochloride tablet 100 mg (ANDA)
Amiodarone Hydrochloride tablet 400 mg (ANDA)
|
Advagen Pharma Limited |
Amiodarone Hydrochloride |
D00636
|
Chlordiazepoxide Hydrochloride capsule 5 mg (ANDA)
Chlordiazepoxide Hydrochloride capsule 10 mg (ANDA)
Chlordiazepoxide Hydrochloride capsule 25 mg (ANDA)
|
Chartwell RX, LLC |
Chlordiazepoxide Hydrochloride |
D00693
|
|
bimatoprost solution/ drops .3 mg/mL (ANDA)
|
Alembic Pharmaceuticals Inc. |
bimatoprost |
D02724
|
|
IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE solution 2.5 mg/3mL (ANDA)
|
Ritedose Pharmaceuticals, LLC |
Ipratropium Bromide and Albuterol Sulfate |
D10256
|
|
Butalbital, Acetaminophen, and Caffeine capsule 300 mg (ANDA)
|
Actavis Pharma, Inc. |
Butalbital, Acetaminophen, and Caffeine |
D11850
|
|
MESALAMINE capsule, extended release 375 mg (ANDA)
|
Camber Pharmaceuticals, Inc. |
MESALAMINE |
D00377
|
|
PRAVASTATIN SODIUM tablet 20 mg (ANDA)
|
A-S Medication Solutions |
PRAVASTATIN SODIUM |
D00893
|
Felodipine tablet, extended release 2.5 mg (ANDA)
Felodipine tablet, extended release 5 mg (ANDA)
Felodipine tablet, extended release 10 mg (ANDA)
|
Chartwell RX, LLC |
Felodipine |
D00319
|
|
Fluorouracil injection, solution 50 mg/mL (ANDA)
|
Alembic Pharmaceuticals Inc. |
Fluorouracil |
D00584
|
esmolol hydrochloride in sodium chloride injection 10 mg/mL (ANDA)
esmolol hydrochloride in sodium chloride injection 20 mg/mL (ANDA)
|
Mylan Institutional LLC |
esmolol hydrochloride in sodium chloride |
D00644
|
Prucalopride tablet, film coated 1 mg (ANDA)
Prucalopride tablet, film coated 2 mg (ANDA)
|
Apotex Corp. |
Prucalopride |
D10152
|
|
Nitrous Oxide gas 990 mL/L (NDA)
|
Quality Air Products Inc |
Nitrous Oxide |
D00102
|
|
CHLORPROMAZINE HYDROCHLORIDE injection 25 mg/mL (ANDA)
|
Eugia US LLC |
CHLORPROMAZINE HYDROCHLORIDE |
D00789
|