| Product |
Company |
Generic name |
KEGG DRUG |
|
VARIVAX injection, powder, lyophilized, for suspension 1350 [PFU]/.5mL (BLA)
|
Merck Sharp & Dohme LLC |
Varicella Virus Vaccine Live |
D08777
|
|
Leukotrap WB System solution 2.23 g/70mL (NDA)
|
GVS TM INC |
CPDA-1 Blood Bag Collection System |
D02954
|
|
Leukotrap WB System solution 2.23 g/70mL (NDA)
|
GVS TM INC |
CPDA-1 Blood Bag Collection System |
D02954
|
|
Leukotrap WB system - CP2D solution 3.21 g/63mL (NDA)
|
GVS TM INC |
CP2D/AS-3 Anticoagulant and Additive System |
|
|
Leukotrap WB System solution 2.01 g/63mL (NDA)
|
GVS TM INC |
CPDA-1 Blood Bag Collection System |
D02954
|
RISPERIDONE tablet, orally disintegrating .5 mg (ANDA)
RISPERIDONE tablet, orally disintegrating 1 mg (ANDA)
RISPERIDONE tablet, orally disintegrating 2 mg (ANDA)
RISPERIDONE tablet, orally disintegrating 3 mg (ANDA)
RISPERIDONE tablet, orally disintegrating 4 mg (ANDA)
|
Amerisyn LLC |
RISPERIDONE |
D00426
|
MEXILETINE HYDROCHLORIDE capsule 150 mg (ANDA)
MEXILETINE HYDROCHLORIDE capsule 200 mg (ANDA)
MEXILETINE HYDROCHLORIDE capsule 250 mg (ANDA)
|
Amerisyn LLC |
mexiletine hydrochloride |
D00639
|
|
Valacyclovir tablet 1000 mg (ANDA)
|
St. Mary's Medical Park Pharmacy |
Valacyclovir |
D00398
|
Everolimus tablet 2.5 mg (ANDA)
Everolimus tablet 5 mg (ANDA)
Everolimus tablet 7.5 mg (ANDA)
Everolimus tablet 10 mg (ANDA)
|
Hikma Pharmaceuticals USA Inc. |
Everolimus |
D02714
|
Pantoprazole Sodium tablet, delayed release 20 mg (ANDA)
Pantoprazole Sodium tablet, delayed release 40 mg (ANDA)
|
American Health Packaging |
Pantoprazole Sodium |
D02593
|
|
Allopurinol tablet 300 mg (ANDA)
|
REMEDYREPACK INC. |
Allopurinol |
D00224
|
|
QIVIGY kthm injection, solution 5 g/50mL (BLA)
|
Kedrion S.p.A. |
human immunoglobulin g |
D06458
|
|
Phendimetrazine Tartrate tablet 35 mg (ANDA)
|
Preferred Pharmaceuticals Inc. |
Phendimetrazine Tartrate |
D02080
|
|
Buspirone Hydrochloride tablet 10 mg (ANDA)
|
Proficient Rx LP |
Buspirone Hydrochloride |
D00702
|
|
Amoxicillin and Clavulanate Potassium tablet, film coated 875 mg (ANDA)
|
REMEDYREPACK INC. |
Amoxicillin and Clavulanate Potassium |
D06485
|
|
Mycophenolate Mofetil powder, for suspension 200 mg/mL (ANDA)
|
QUAGEN PHARMACEUTICALS LLC |
Mycophenolate Mofetil |
D00752
|
|
prazosin hydrochloride capsule 2 mg (ANDA)
|
REMEDYREPACK INC. |
prazosin hydrochloride |
D00609
|
|
Mirtazapine tablet, film coated 15 mg (ANDA)
|
Cardinal Health 107, LLC |
Mirtazapine |
D00563
|
|
Ultiva injection, powder, lyophilized, for solution 1 mg/mL (NDA)
|
Mylan Institutional LLC |
Remifentanil Hydrochloride |
D01177
|
|
Trospium Chloride capsule, extended release 60 mg (ANDA)
|
Actavis Pharma, Inc. |
Trospium Chloride |
D01103
|
|
prazosin hydrochloride capsule 1 mg (ANDA)
|
REMEDYREPACK INC. |
prazosin hydrochloride |
D00609
|
|
Tizanidine tablet 4 mg (ANDA)
|
REMEDYREPACK INC. |
Tizanidine |
D00776
|
|
Pregabalin capsule 300 mg (ANDA)
|
REMEDYREPACK INC. |
Pregabalin |
D02716
|
|
Tramadol Hydrochloride tablet, coated 50 mg (ANDA)
|
REMEDYREPACK INC. |
Tramadol Hydrochloride |
D01355
|
Bisoprolol Fumarate and Hydrochlorothiazide tablet 2.5 mg (ANDA)
Bisoprolol Fumarate and Hydrochlorothiazide tablet 5 mg (ANDA)
Bisoprolol Fumarate and Hydrochlorothiazide tablet 10 mg (ANDA)
|
ANI Pharmaceuticals, Inc. |
Bisoprolol Fumarate and Hydrochlorothiazide |
D10275
|
Xerava injection, powder, lyophilized, for solution 100 mg (NDA)
Xerava injection, powder, lyophilized, for solution 50 mg (NDA)
|
Tetraphase Pharmaceuticals, Inc. |
eravacycline |
D10421
|
rosuvstatin tablet, film coated 5 mg (ANDA)
rosuvstatin tablet, film coated 10 mg (ANDA)
rosuvstatin tablet, film coated 20 mg (ANDA)
rosuvstatin tablet, film coated 40 mg (ANDA)
|
Lifestar Pharma LLC |
rosuvstatin |
D01915
|
|
Finasteride tablet, film coated 5 mg (ANDA)
|
REMEDYREPACK INC. |
Finasteride |
D00321
|
|
Amitriptyline Hydrochloride tablet, film coated 10 mg (ANDA)
|
REMEDYREPACK INC. |
Amitriptyline Hydrochloride |
D00809
|
|
BACLOFEN tablet 10 mg (ANDA)
|
REMEDYREPACK INC. |
BACLOFEN |
D00241
|
|
DASH Chlorhexidine Gluconate 0.12% Oral Rinse liquid 1.2 mg/mL (ANDA)
|
Cardinal Health 107, LLC |
Chlorhexidine Gluconate 0.12% Oral Rinse |
D00858
|
|
Haloperidol tablet 10 mg (ANDA)
|
REMEDYREPACK INC. |
haloperidol |
D00136
|
|
Atorvastatin Calcium tablet, film coated 80 mg (ANDA)
|
Cardinal Health 107, LLC |
atorvastatin calcium |
D02258
|
|
Spironolactone tablet, coated 50 mg (ANDA)
|
REMEDYREPACK INC. |
Spironolactone |
D00443
|
PADCEV EJFV injection, powder, lyophilized, for solution 20 mg/2mL (BLA)
PADCEV EJFV injection, powder, lyophilized, for solution 30 mg/3mL (BLA)
|
SEAGEN INC. |
ENFORTUMAB VEDOTIN |
D11525
|
OGIVRI injection, powder, lyophilized, for solution 150 mg/7.4mL (BLA)
OGIVRI injection, powder, lyophilized, for solution 420 mg/20mL (BLA)
OGIVRI kit (BLA)
|
Biocon Biologics Inc. |
trastuzumab-dkst |
D03257
|
|
Amitriptyline Hydrochloride tablet, film coated 25 mg (ANDA)
|
REMEDYREPACK INC. |
Amitriptyline Hydrochloride |
D00809
|
Vancomycin Hydrochloride injection, powder, for solution 750 mg (NDA)
Vancomycin Hydrochloride injection, powder, for solution 1.25 g (NDA)
Vancomycin Hydrochloride injection, powder, for solution 1.5 g (NDA)
|
Avenacy, LLC |
vancomycin hydrochloride |
D00926
|
|
Amoxicillin and Clavulanate Potassium tablet, film coated 875 mg (ANDA)
|
REMEDYREPACK INC. |
Amoxicillin and Clavulanate Potassium |
D06485
|
|
Ferumoxytol injection 510 mg7mL (ANDA)
|
Sandoz Inc |
ferumoxytol |
D04177
|