| Product |
Company |
Generic name |
KEGG DRUG |
|
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
|
|
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
|
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
|
|
Prazosin Hydrochloride capsule 5 mg (ANDA)
|
Preferred Pharmaceuticals Inc. |
Prazosin Hydrochloride |
D00609
|
Lumryz for suspension, extended release 4.5 g (NDA)
Lumryz for suspension, extended release 6 g (NDA)
Lumryz for suspension, extended release 7.5 g (NDA)
Lumryz for suspension, extended release 9 g (NDA)
Lumryz kit (NDA)
|
Avadel CNS Pharmaceuticals, LLC |
sodium oxybate |
D05866
|
|
levonorgestrel and ethinyl estradiol kit (NDA)
|
Acella Pharmaceuticals |
levonorgestrel and ethinyl estradiol |
D04482
|
Etodolac tablet, film coated 400 mg (ANDA)
Etodolac tablet, film coated 500 mg (ANDA)
|
Unichem Pharmaceuticals (USA), Inc. |
Etodolac |
D00315
|
|
Rabeprazole sodium tablet, delayed release 20 mg (ANDA)
|
Preferred Pharmaceuticals Inc. |
Rabeprazole sodium |
D00724
|
|
Diclofenac Potassium tablet, film coated 25 mg (ANDA)
|
NIVAGEN PHARMACEUTICALS, INC. |
Diclofenac Potassium Tablets |
D00903
|
|
Oxygen gas 990 mL/L (NDA)
|
Rotech Healthcare Inc |
Oxygen |
D00003
|
|
Nitrogen gas 990 mL/L (NDA)
|
TIMS SOUTH TEXAS LLC |
Nitrogen |
D00083
|
fluphenazine hydrochloride tablet, film coated 1 mg (ANDA)
fluphenazine hydrochloride tablet, film coated 2.5 mg (ANDA)
fluphenazine hydrochloride tablet, film coated 5 mg (ANDA)
fluphenazine hydrochloride tablet, film coated 10 mg (ANDA)
|
Chartwell RX, LLC |
fluphenazine hydrochloride |
D00791
|
|
Oxygen gas 995 mL/L (NDA)
|
Humphries, Inc. |
Oxygen |
D00003
|
|
ANASTROZOLE tablet 1 mg (ANDA)
|
NuCare Pharmaceuticals, Inc. |
ANASTROZOLE |
D00960
|
Calcitriol capsule .25 ug (ANDA)
Calcitriol capsule .5 ug (ANDA)
|
Chartwell RX, LLC |
Calcitriol |
D00129
|
Chlorthalidone tablet 25 mg (ANDA)
Chlorthalidone tablet 50 mg (ANDA)
|
Nivagen Pharmaceuticals, INC. |
Chlorthalidone |
D00272
|
|
ZELBORAF tablet, film coated 240 mg (NDA)
|
Genentech, Inc. |
Vemurafenib |
D09996
|
Provigil tablet 100 mg (NDA)
Provigil tablet 200 mg (NDA)
|
Golden State Medical Supply, Inc. |
modafinil |
D01832
|
|
PREGABALIN capsule 225 mg (ANDA)
|
Bryant Ranch Prepack |
PREGABALIN |
D02716
|
Rosuvastatin Calcium tablet, film coated 5 mg (ANDA)
Rosuvastatin Calcium tablet, film coated 10 mg (ANDA)
Rosuvastatin Calcium tablet, film coated 20 mg (ANDA)
Rosuvastatin Calcium tablet, film coated 40 mg (ANDA)
|
Zhejiang Yongtai Pharmaceutical Co., Ltd. |
rosuvastatin calcium |
D01915
|
|
Sulfamethoxazole and Trimethoprim tablet 800 mg (ANDA)
|
VERITYRX, LLC |
Sulfamethoxazole and Trimethoprim |
D00285
|