| Product |
Company |
Generic name |
KEGG DRUG |
|
VERSACLOZ suspension 50 mg/mL (NDA)
|
TruPharma LLC |
Clozapine |
D00283
|
|
ETOPOPHOS injection, powder, lyophilized, for solution 100 mg (NDA)
|
H2-Pharma, LLC |
etoposide phosphate |
D04107
|
Azithromycin tablet, film coated 250 mg (ANDA)
Azithromycin tablet, film coated 500 mg (ANDA)
|
Aurobindo Pharma Limited |
Azithromycin |
D02134
|
|
Mifepristone tablet 200 mg (ANDA)
|
Evita Solutions LLC |
MIFEPRISTONE |
D00585
|
|
Mycophenolate Mofetil capsule 250 mg (ANDA)
|
Teva Pharmaceuticals USA, Inc. |
Mycophenolate Mofetil |
D00752
|
Nadolol tablet 20 mg (ANDA)
Nadolol tablet 40 mg (ANDA)
Nadolol tablet 80 mg (ANDA)
|
BluePoint Laboratories |
Nadolol |
D00432
|
|
FLUOROURACIL injection, solution 50 mg/mL (ANDA)
|
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. |
FLUOROURACIL |
D00584
|
|
FLUOROURACIL injection, solution 50 mg/mL (ANDA)
|
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. |
FLUOROURACIL |
D00584
|
|
DOXYCYCLINE HYCLATE tablet 100 mg (ANDA)
|
NuCare Pharmaceuticals,Inc. |
DOXYCYCLINE HYCLATE |
D02129
|
|
Citalopram tablet, film coated 40 mg (ANDA)
|
REMEDYREPACK INC. |
Citalopram Hydrobromide |
D00822
|
Losartan Potassium tablet, film coated 50 mg (ANDA)
Losartan Potassium tablet, film coated 25 mg (ANDA)
Losartan Potassium tablet, film coated 100 mg (ANDA)
|
Cardinal Health 107, LLC |
Losartan Potassium |
D00357
|
Shingrix kit (BLA)
Shingrix injection, solution 50 ug/.5mL (BLA)
|
GlaxoSmithKline Biologicals SA |
Zoster Vaccine Recombinant, Adjuvanted |
D11562
|
|
Guanfacine tablet 1 mg (ANDA)
|
REMEDYREPACK INC. |
Guanfacine |
D00606
|
Methocarbamol tablet 500 mg (ANDA)
Methocarbamol tablet 750 mg (ANDA)
|
Cardinal Health 107, LLC |
Methocarbamol |
D00402
|
|
DAPTACEL injection, suspension 15 [Lf]/.5mL (BLA)
|
Sanofi Vaccines US Inc. |
corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated), clostridium tetani toxoid antigen (formaldehyde inactivated), bordetella pertussis toxoid antigen (glutaraldehyde inactivated), bordetella pertussis filamentous hemagglutinin antigen (formaldehyde inactivated), bordetella pertussis pertactin antigen, and bordetella pertussis fimbriae 2/3 antigen |
D05356
|
|
Ondansetron Hydrochloride tablet, film coated 4 mg (ANDA)
|
Proficient Rx LP |
Ondansetron Hydrochloride |
D00678
|
Topiramate capsule, extended release 25 mg (ANDA)
Topiramate capsule, extended release 50 mg (ANDA)
Topiramate capsule, extended release 100 mg (ANDA)
|
Par Health USA, LLC |
Topiramate |
D00537
|
|
SEREVENT DISKUS powder, metered 50 ug (NDA)
|
GlaxoSmithKline LLC |
salmeterol xinafoate |
D00687
|
atomoxetine capsule 10 mg (ANDA)
atomoxetine capsule 18 mg (ANDA)
atomoxetine capsule 25 mg (ANDA)
atomoxetine capsule 40 mg (ANDA)
atomoxetine capsule 60 mg (ANDA)
atomoxetine capsule 80 mg (ANDA)
atomoxetine capsule 100 mg (ANDA)
|
Northstar Rx LLC |
atomoxetine |
D02574
|
|
Rufinamide suspension 40 mg/mL (ANDA)
|
American Health Packaging |
Rufinamide |
D05775
|
|
ENCELTO implant 440000 [arb'U] (BLA)
|
Neurotech Pharmaceuticals, Inc. |
revakinagene taroretcel-lwey |
D13084
|
|
Fluconazole tablet 150 mg (ANDA)
|
REMEDYREPACK INC. |
Fluconazole |
D00322
|
|
Doxepin tablet 6 mg (ANDA)
|
REMEDYREPACK INC. |
doxepin hydrochloride |
D00814
|
TIMOLOL MALEATE solution/ drops 2.5 mg/mL (ANDA)
TIMOLOL MALEATE solution/ drops 5 mg/mL (ANDA)
|
Rising Pharma Holdings, Inc. |
timolol maleate |
D00603
|
|
Folic Acid tablet 1 mg (ANDA)
|
REMEDYREPACK INC. |
Folic Acid |
D00070
|
Iron Sucrose injection, solution 100 mg/5mL (ANDA)
Iron Sucrose injection, solution 200 mg0mL (ANDA)
Iron Sucrose injection, solution 50 mg/2.5mL (ANDA)
|
Mylan Institutional LLC |
Iron Sucrose |
D04616
|
|
Topiramate tablet, film coated 50 mg (ANDA)
|
REMEDYREPACK INC. |
Topiramate |
D00537
|
|
Ibuprofen tablet, film coated 600 mg (ANDA)
|
Direct_Rx |
Ibuprofen |
D00126
|
|
Mirtazapine tablet, film coated 15 mg (ANDA)
|
REMEDYREPACK INC. |
Mirtazapine |
D00563
|
|
Lisinopril and Hydrochlorothiazide tablet 10 mg (ANDA)
|
Proficient Rx LP |
Lisinopril and Hydrochlorothiazide Tablets |
D10268
|
|
RIVAROXABAN tablet 2.5 mg (ANDA)
|
Micro Labs Limited |
RIVAROXABAN |
D07086
|
|
METOPROLOL TARTRATE tablet 100 mg (ANDA)
|
Proficient Rx LP |
METOPROLOL TARTRATE |
D00601
|
|
Omeprazole capsule, delayed release 20 mg (ANDA)
|
NuCare Pharmaceuticals, Inc. |
Omeprazole |
D00455
|
ZOLPIDEM TARTRATE tablet 5 mg (ANDA)
ZOLPIDEM TARTRATE tablet 10 mg (ANDA)
|
A-S Medication Solutions |
zolpidem tartrate |
D00706
|
Frindovyx injection 500 mg/mL (NDA)
Frindovyx injection 1 g/2mL (NDA)
Frindovyx injection 2 g/4mL (NDA)
|
AVYXA Pharma, LLC |
Cyclophosphamide |
D00287
|
|
Atorvastatin calcium tablet 40 mg (ANDA)
|
REMEDYREPACK INC. |
Atorvastatin calcium |
D02258
|
|
Glycopyrrolate injection, solution .2 mg/mL (ANDA)
|
American Regent, Inc. |
Glycopyrrolate |
D00540
|
Tivicay tablet, film coated 10 mg (NDA)
Tivicay tablet, film coated 25 mg (NDA)
Tivicay tablet, film coated 50 mg (NDA)
Tivicay PD tablet, for suspension 5 mg (NDA)
|
ViiV Healthcare Company |
dolutegravir sodium |
D10113
|
IMJUDO injection, solution 25 mg.25mL (BLA)
IMJUDO injection, solution 300 mg5mL (BLA)
|
AstraZeneca Pharmaceuticals LP |
tremelimumab |
D06657
|
|
Ketorolac Tromethamine injection, solution 15 mg/mL (ANDA)
|
Cardinal Health 107, LLC |
KETOROLAC TROMETHAMINE |
D00813
|