| Product |
Company |
Generic name |
KEGG DRUG |
|
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
|
|
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
|
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
|
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
|
|
PROCHLORPERAZINE MALEATE tablet 10 mg (ANDA)
|
Cardinal Health 107, LLC |
Prochlorperazine maleate |
D00479
|
Valcyte tablet, film coated 450 mg (NDA)
Valcyte powder, for solution 50 mg/mL (NDA)
|
H2-Pharma, LLC |
valganciclovir |
D03256
|
|
DAPTOMYCIN injection, powder, lyophilized, for solution 350 mg/7mL (ANDA)
|
Meitheal Pharmaceuticals Inc. |
DAPTOMYCIN |
D01080
|
Estradiol and Norethindrone Acetate tablet 1 mg (ANDA)
Estradiol and Norethindrone Acetate tablet .5 mg (ANDA)
|
Ingenus Pharmaceuticals, LLC |
Estradiol and Norethindrone Acetate |
D09188
|
METOLAZONE tablet 2.5 mg (ANDA)
METOLAZONE tablet 5 mg (ANDA)
METOLAZONE tablet 10 mg (ANDA)
|
Aarkish Pharmaceuticals NJ Inc. |
metolazone |
D00431
|
|
MECLIZINE HYDROCHLORIDE tablet 12.5 mg (ANDA)
|
Bryant Ranch Prepack |
Meclizine Hydrochloride |
D01317
|
|
Carvedilol tablet, film coated 25 mg (ANDA)
|
Proficient Rx LP |
Carvedilol |
D00255
|
|
POSACONAZOLE tablet, delayed release 100 mg (ANDA)
|
Lupin Pharmaceuticals, Inc. |
POSACONAZOLE |
D02555
|
Amiodarone Hydrochloride tablet 100 mg (ANDA)
Amiodarone Hydrochloride tablet 200 mg (ANDA)
Amiodarone Hydrochloride tablet 400 mg (ANDA)
|
Chartwell RX, LLC |
Amiodarone Hydrochloride |
D00636
|
Valium tablet 2 mg (NDA)
Valium tablet 5 mg (NDA)
|
Roche Laboratories Inc. |
diazepam |
D00293
|
Monoferric injection, solution 100 mg/mL (NDA)
Monoferric injection, solution 500 mg/5mL (NDA)
Monoferric injection, solution 1000 mg0mL (NDA)
|
Pharmacosmos Therapeutics Inc. |
Ferric derisomaltose |
D11808
|