| Product |
Company |
Generic name |
KEGG DRUG |
|
Pregabalin capsule 50 mg (ANDA)
|
REMEDYREPACK INC.
|
Pregabalin
|
D02716
|
CELECOXIB capsule 100 mg (ANDA)
CELECOXIB capsule 200 mg (ANDA)
|
American Health Packaging
|
Celecoxib
|
D00567
|
|
ofloxacin solution 3 mg/mL (ANDA)
|
REMEDYREPACK INC.
|
ofloxacin otic
|
D00453
|
|
VARIVAX injection, powder, lyophilized, for suspension 1350 [PFU]/.5mL (BLA)
|
Merck Sharp & Dohme LLC
|
Varicella Virus Vaccine Live
|
D08777
|
|
Leukotrap WB System solution .019 g/70mL (NDA)
|
GVS TM INC
|
CPDA-1 Blood Bag Collection System
|
|
|
Leukotrap WB System solution .019 g/70mL (NDA)
|
GVS TM INC
|
CPDA-1 Blood Bag Collection System
|
|
|
Leukotrap WB system - CP2D solution 3.21 g/63mL (NDA)
|
GVS TM INC
|
CP2D/AS-3 Anticoagulant and Additive System
|
|
|
Leukotrap WB System solution .017 g/63mL (NDA)
|
GVS TM INC
|
CPDA-1 Blood Bag Collection System
|
|
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
|
TYZAVAN injection, solution 1.25 g/250mL (NDA)
TYZAVAN injection, solution 1.75 g/350mL (NDA)
TYZAVAN injection, solution 750 mg50mL (NDA)
TYZAVAN injection, solution 1.5 g/300mL (NDA)
TYZAVAN injection, solution 2 g/400mL (NDA)
TYZAVAN injection, solution 500 mg00mL (NDA)
TYZAVAN injection, solution 1 g/200mL (NDA)
|
Hikma Pharmaceuticals USA Inc.
|
Vancomycin
|
D00926
|
|
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
|
Amnesteem capsule 10 mg (ANDA)
Amnesteem capsule 20 mg (ANDA)
Amnesteem capsule 40 mg (ANDA)
Amnesteem capsule 30 mg (ANDA)
|
Mylan Pharmaceuticals Inc.
|
isotretinoin
|
D00348
|
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
|