| Product |
Company |
Generic name |
KEGG DRUG |
|
FLUOROURACIL injection, solution 50 mg/mL (ANDA)
|
Eugia US LLC |
FLUOROURACIL |
D00584
|
PREVYMIS tablet, film coated 240 mg (NDA)
PREVYMIS tablet, film coated 480 mg (NDA)
PREVYMIS injection, solution 20 mg/mL (NDA)
PREVYMIS pellet 120 mg (NDA)
PREVYMIS pellet 20 mg (NDA)
|
Merck Sharp & Dohme LLC |
LETERMOVIR |
D10801
|
ELTROMBOPAG tablet 12.5 mg (ANDA)
ELTROMBOPAG tablet 25 mg (ANDA)
ELTROMBOPAG tablet 50 mg (ANDA)
ELTROMBOPAG tablet 75 mg (ANDA)
|
Zydus Pharmaceuticals USA Inc. |
eltrombopag |
D03978
|
|
Albuterol Sulfate aerosol, metered 90 ug (ANDA)
|
Preferred Pharmaceuticals Inc. |
Albuterol Sulfate |
D00683
|
|
Risperidone solution 1 mg/mL (ANDA)
|
ANI Pharmaceuticals, Inc. |
Risperidone |
D00426
|
|
Quetiapine fumarate tablet 50 mg (ANDA)
|
Preferred Pharmaceuticals, Inc. |
quetiapine fumarate |
D00458
|
|
Ranolazine tablet, extended release 500 mg (ANDA)
|
NCS HealthCare of KY, LLC dba Vangard Labs |
Ranolazine |
D05700
|
|
ondansetron tablet, orally disintegrating 4 mg (ANDA)
|
Cardinal Health 107, LLC |
ondansetron |
D00678
|
|
ACETAMINOPHEN AND CODEINE PHOSPHATE tablet 300 mg (ANDA)
|
A-S Medication Solutions |
acetaminophen and codeine phosphate |
D02146
|
|
Paroxetine tablet, film coated 20 mg (ANDA)
|
Preferred Pharmaceuticals Inc. |
paroxetine hydrochloride hemihydrate |
D02260
|
|
ONDANSETRON HYDROCHLORIDE solution 2 mg/mL (ANDA)
|
Cardinal Health 107, LLC |
ONDANSETRON HYDROCHLORIDE |
D00678
|
Olanzapine tablet, film coated 5 mg (ANDA)
Olanzapine tablet, film coated 10 mg (ANDA)
|
Cardinal Health 107, LLC |
Olanzapine |
D00454
|
|
Morphine sulfate tablet, film coated, extended release 100 mg (ANDA)
|
Bryant Ranch Prepack |
morphine sulfate |
D00842
|
Lidocaine Hydrochloride injection, solution 10 mg/mL (ANDA)
Lidocaine Hydrochloride injection, solution 5 mg/mL (ANDA)
Lidocaine Hydrochloride injection, solution 15 mg/mL (ANDA)
Lidocaine Hydrochloride injection, solution 20 mg/mL (ANDA)
|
Hospira, Inc. |
LIDOCAINE HYDROCHLORIDE |
D08127
|
|
Azithromycin Dihydrate tablet, film coated 500 mg (ANDA)
|
Preferred Pharmaceuticals Inc. |
Azithromycin dihydrate |
D02134
|
Ropivacaine Hydrochloride injection, solution 2 mg/mL (ANDA)
Ropivacaine Hydrochloride injection, solution 5 mg/mL (ANDA)
|
Hikma Pharmaceuticals USA Inc. |
Ropivacaine Hydrochloride |
D04048
|
HYRIMOZ injection, solution 40 mg/.4mL (BLA)
HYRIMOZ injection, solution 40 mg/.8mL (BLA)
HYRIMOZ injection, solution 80 mg/.8mL (BLA)
HYRIMOZ injection, solution 20 mg/.2mL (BLA)
HYRIMOZ kit (BLA)
|
Cordavis Limited |
adalimumab-adaz |
D02597
|
Oxymorphone hydrochloride tablet, film coated, extended release 5 mg (ANDA)
Oxymorphone hydrochloride tablet, film coated, extended release 7.5 mg (ANDA)
Oxymorphone hydrochloride tablet, film coated, extended release 10 mg (ANDA)
Oxymorphone hydrochloride tablet, film coated, extended release 15 mg (ANDA)
Oxymorphone hydrochloride tablet, film coated, extended release 20 mg (ANDA)
Oxymorphone hydrochloride tablet, film coated, extended release 30 mg (ANDA)
Oxymorphone hydrochloride tablet, film coated, extended release 40 mg (ANDA)
|
Amneal Pharmaceuticals LLC |
Oxymorphone hydrochloride |
D00844
|
Fluoxetine capsule 10 mg (ANDA)
Fluoxetine capsule 20 mg (ANDA)
Fluoxetine capsule 40 mg (ANDA)
|
Aurobindo Pharma Limited |
Fluoxetine Hydrochloride |
D00823
|
|
YONDELIS injection, powder, lyophilized, for solution .05 mg/mL (NDA)
|
Janssen Products, LP |
Trabectedin |
D06199
|
tacrolimus capsule .5 mg (ANDA)
tacrolimus capsule 1 mg (ANDA)
tacrolimus capsule 5 mg (ANDA)
|
Glenmark Pharmaceuticals Inc., USA |
tacrolimus |
D00107
|
|
Diclofenac Sodium tablet, delayed release 50 mg (ANDA)
|
Preferred Pharmaceuticals Inc. |
Diclofenac Sodium |
D00904
|
Cyclophosphamide injection, powder, for solution 500 mg/25mL (ANDA)
Cyclophosphamide injection, powder, for solution 1 g/50mL (ANDA)
Cyclophosphamide injection, powder, for solution 2 g00mL (ANDA)
|
Amneal Pharmaceuticals LLC |
Cyclophosphamide |
D00287
|
|
AMPYRA tablet, film coated, extended release 10 mg (NDA)
|
Merz Pharmaceuticals, LLC |
Dalfampridine |
D04127
|
|
Oxycodone Hydrochloride capsule 5 mg (ANDA)
|
ANI Pharmaceuticals, Inc. |
Oxycodone Hydrochloride |
D00847
|
Tocilizumab-anoh injection, solution, concentrate 80 mg/4mL (BLA)
Tocilizumab-anoh injection, solution, concentrate 200 mg0mL (BLA)
Tocilizumab-anoh injection, solution, concentrate 400 mg/20mL (BLA)
Tocilizumab-anoh injection, solution, concentrate 162 mg/.9mL (BLA)
|
CELLTRION USA, Inc. |
tocilizumab |
D02596
|
|
LEVOCETIRIZINE DIHYDROCHLORIDE tablet 5 mg (ANDA)
|
Glenmark Pharmaceuticals Inc., USA |
levocetirizine dihydrochloride |
D08118
|
|
Rosuvastatin Calcium tablet 10 mg (ANDA)
|
Preferred Pharmaceuticals Inc. |
Rosuvastatin Calcium |
D01915
|
|
Cefazolin injection, powder, for solution 1 g (ANDA)
|
Hospira, Inc |
Cefazolin |
D00905
|
Benazepril Hydrochloride tablet, film coated 10 mg (ANDA)
Benazepril Hydrochloride tablet, film coated 20 mg (ANDA)
Benazepril Hydrochloride tablet, film coated 40 mg (ANDA)
|
Aurobindo Pharma Limited |
Benazepril Hydrochloride |
D00620
|
|
Oxycodone Hydrochloride solution 5 mg/5mL (ANDA)
|
Eywa Pharma Inc |
Oxycodone Hydrochloride |
D00847
|
|
Dovato tablet, film coated 50 mg (NDA)
|
ViiV Healthcare Company |
dolutegravir sodium and lamivudine |
D11522
|
|
FLUOROURACIL injection, solution 50 mg/mL (ANDA)
|
Eugia US LLC |
FLUOROURACIL |
D00584
|
|
Baclofen tablet 10 mg (ANDA)
|
Preferred Pharmaceuticals Inc. |
Baclofen |
D00241
|
Trazodone Hydrochloride tablet 50 mg (ANDA)
Trazodone Hydrochloride tablet 100 mg (ANDA)
Trazodone Hydrochloride tablet 150 mg (ANDA)
Trazodone Hydrochloride tablet 300 mg (ANDA)
|
Zydus Pharmaceuticals USA Inc. |
Trazodone Hydrochloride |
D00820
|
Glatiramer Acetate injection, solution 20 mg/mL (ANDA)
Glatiramer Acetate injection, solution 40 mg/mL (ANDA)
|
UPSHER-SMITH LABORATORIES, LLC |
Glatiramer Acetate Injection |
D04318
|
Buprenorphine and Naloxone film, soluble 2 mg (ANDA)
Buprenorphine and Naloxone film, soluble 8 mg (ANDA)
|
Dr.Reddys Laboratories Inc |
Buprenorphine and Naloxone |
D10250
|
|
HAILEY Fe 1/20 kit (ANDA)
|
Glenmark Pharmaceuticals Inc., USA |
norethindrone acetate and ethinyl estradiol and ferrous fumarate |
D04483
|
Buprenorphine and Naloxone film, soluble 4 mg (ANDA)
Buprenorphine and Naloxone film, soluble 12 mg (ANDA)
|
Dr.Reddys Laboratories Inc |
Buprenorphine and Naloxone |
D10250
|
Daptomycin injection, powder, lyophilized, for solution 500 mg0mL (NDA)
Daptomycin injection, powder, lyophilized, for solution 350 mg/7mL (NDA)
|
Hikma Pharmaceuticals USA Inc. |
daptomycin |
D01080
|