| Product |
Company |
Generic name |
KEGG DRUG |
Prucalopride tablet, film coated 1 mg (ANDA)
Prucalopride tablet, film coated 2 mg (ANDA)
|
Apotex Corp. |
Prucalopride |
D10152
|
ROPIVACAINE HYDROCHLORIDE injection, solution 2 mg/mL (ANDA)
ROPIVACAINE HYDROCHLORIDE injection, solution 5 mg/mL (ANDA)
ROPIVACAINE HYDROCHLORIDE injection, solution 10 mg/mL (ANDA)
|
Glenmark Pharmaceuticals Inc., USA |
ROPIVACAINE HYDROCHLORIDE |
D04048
|
|
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
|
Diclofenac Sodium tablet, delayed release 25 mg (ANDA)
Diclofenac Sodium tablet, delayed release 50 mg (ANDA)
Diclofenac Sodium tablet, delayed release 75 mg (ANDA)
|
Umedica Laboratories USA Inc. |
Diclofenac Sodium |
D00904
|
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
|
|
Tolectin tablet, film coated 600 mg (ANDA)
|
Poly Pharmaceuticals, Inc. |
tolmetin sodium |
D00158
|
|
levonorgestrel and ethinyl estradiol kit (NDA)
|
Acella Pharmaceuticals |
levonorgestrel and ethinyl estradiol |
D04482
|
|
PERJETA injection, solution, concentrate 30 mg/mL (BLA)
|
Genentech, Inc. |
Pertuzumab |
D05446
|
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
|
|
aripiprazole tablet 2 mg (ANDA)
|
REMEDYREPACK INC. |
aripiprazole |
D01164
|
|
Lisinopril tablet 20 mg (ANDA)
|
Cardinal Health 107, LLC |
Lisinopril |
D00362
|
|
Diclofenac Potassium tablet, film coated 25 mg (ANDA)
|
NIVAGEN PHARMACEUTICALS, INC. |
Diclofenac Potassium Tablets |
D00903
|
Diclofenac Potassium tablet, film coated 50 mg (ANDA)
Diclofenac Potassium tablet, film coated 25 mg (ANDA)
|
Umedica Laboratories USA Inc. |
Diclofenac Potassium Tablets |
D00903
|
|
KADCYLA injection, powder, lyophilized, for solution 20 mg/mL (BLA)
|
Genentech, Inc. |
ADO-TRASTUZUMAB EMTANSINE |
D09980
|
Phesgo injection, solution 30000 U5mL (BLA)
Phesgo injection, solution 20000 U0mL (BLA)
|
Genentech, Inc. |
pertuzumab, trastuzumab, and hyaluronidase-zzxf |
D11934
|
|
Oxygen gas 990 mL/L (NDA)
|
Rotech Healthcare Inc |
Oxygen |
D00003
|
|
Nitrogen gas 990 mL/L (NDA)
|
TIMS SOUTH TEXAS LLC |
Nitrogen |
D00083
|
Lidocaine Hydrochloride and Epinephrine injection, solution 5 ug/mL (ANDA)
Lidocaine Hydrochloride and Epinephrine injection, solution 10 ug/mL (ANDA)
|
Hospira, Inc. |
LIDOCAINE HYDROCHLORIDE and EPINEPHRINE |
D04052
|
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
|
|
Ascor injection 500 mg/mL (NDA)
|
McGuff Pharmaceuticals, Inc. |
Ascorbic Acid |
D00018
|
|
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
|
|
Ondansetron tablet, orally disintegrating 8 mg (ANDA)
|
NuCare Pharmaceuticals,Inc |
Ondansetron |
D00456
|
Modafinil tablet 100 mg (ANDA)
Modafinil tablet 200 mg (ANDA)
|
Golden State Medical Supply, Inc. |
Modafinil |
D01832
|
|
Bupropion Hydrochloride XL tablet, extended release 300 mg (ANDA)
|
NuCare Pharmaceuticals,Inc. |
Bupropion Hydrochloride |
D00817
|
|
Ketoconazole shampoo, suspension 20 mg/mL (ANDA)
|
NuCare Pharmaceuticals,Inc. |
Ketoconazole |
D00351
|
|
Nitrogen gas 990 mL/L (NDA)
|
Quality Air Products Inc |
Nitrogen |
D00083
|
Pregabalin capsule 25 mg (ANDA)
Pregabalin capsule 50 mg (ANDA)
Pregabalin capsule 75 mg (ANDA)
Pregabalin capsule 100 mg (ANDA)
Pregabalin capsule 150 mg (ANDA)
Pregabalin capsule 200 mg (ANDA)
Pregabalin capsule 225 mg (ANDA)
Pregabalin capsule 300 mg (ANDA)
|
AvKARE |
Pregabalin |
D02716
|
|
Bupropion Hydrochloride XL tablet, extended release 150 mg (ANDA)
|
NuCare Pharmaceuticals, Inc. |
Bupropion Hydrochloride |
D00817
|
|
Quetiapine Fumarate tablet, film coated 25 mg (ANDA)
|
NuCare Pharmaceuticals, Inc. |
Quetiapine Fumarate |
D00458
|