| Product |
Company |
Generic name |
KEGG DRUG |
Xenon gas 10 mCi (NDA)
Xenon gas 20 mCi (NDA)
|
Shine Spect USA, LLC |
Xenon XE-133 |
D06339
|
|
KETAMINE HYDROCHLORIDE injection 100 mg/mL (ANDA)
|
Henry Schein, Inc. |
ketamine hydrochloride |
D00711
|
|
Cardiolite injection, powder, lyophilized, for solution 1 mg/mL (NDA)
|
SHINE SPECT USA, LLC |
TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE |
D01060
|
Duloxetine capsule, delayed release 20 mg (ANDA)
Duloxetine capsule, delayed release 60 mg (ANDA)
Duloxetine capsule, delayed release 30 mg (ANDA)
Duloxetine capsule, delayed release 40 mg (ANDA)
|
HAWAII REPACK, INC. |
Duloxetine |
D01179
|
|
Gabapentin capsule 300 mg (ANDA)
|
REMEDYREPACK INC. |
Gabapentin |
D00332
|
|
Levothyroxine sodium tablet 125 ug (ANDA)
|
REMEDYREPACK INC. |
Levothyroxine Sodium |
D01010
|
azithromycin tablet, film coated 250 mg (ANDA)
azithromycin tablet, film coated 500 mg (ANDA)
|
Major Pharmaceuticals |
azithromycin |
D02134
|
Linezolid injection, solution 200 mg00mL (ANDA)
Linezolid injection, solution 600 mg/300mL (ANDA)
|
Sun Pharmaceutical Industries, Inc. |
linezolid |
D00947
|
|
Dextrose injection, solution 25 g/50mL (NDA)
|
Henry Schein, Inc. |
Dextrose Monohydrate |
D02325
|
|
Allopurinol tablet 100 mg (ANDA)
|
REMEDYREPACK INC. |
allopurinol |
D00224
|
|
Azithromycin tablet, film coated 500 mg (ANDA)
|
NuCare Pharmaceuticals,Inc. |
Azithromycin |
D02134
|
|
Eszopiclone tablet, film coated 2 mg (ANDA)
|
REMEDYREPACK INC. |
Eszopiclone |
D02624
|
Tizanidine tablet 2 mg (ANDA)
Tizanidine tablet 4 mg (ANDA)
|
Dr. Reddy's Laboratories Limited |
Tizanidine |
D00776
|
|
Lisinopril tablet 10 mg (ANDA)
|
REMEDYREPACK INC. |
Lisinopril |
D00362
|
|
Fluconazole tablet 100 mg (ANDA)
|
REMEDYREPACK INC. |
Fluconazole |
D00322
|
Mysoline tablet 50 mg (NDA)
Mysoline tablet 250 mg (NDA)
|
Bausch Health US, LLC |
Primidone |
D00474
|
|
Levothyroxine sodium tablet 137 ug (ANDA)
|
REMEDYREPACK INC. |
Levothyroxine Sodium |
D01010
|
Lamotrigine tablet 100 mg (ANDA)
Lamotrigine tablet 25 mg (ANDA)
|
Cardinal Health 107, LLC |
Lamotrigine |
D00354
|
Lorazepam tablet 1 mg (ANDA)
Lorazepam tablet 2 mg (ANDA)
|
Clinical Solutions Wholesale, LLC |
Lorazepam |
D00365
|
|
Calcitonin Salmon spray, metered 200 [iU] (ANDA)
|
Apotex Corp. |
Calcitonin Salmon |
D00249
|
Saxagliptin and Metformin tablet, film coated, extended release 5 mg (ANDA)
Saxagliptin and Metformin tablet, film coated, extended release 2.5 mg (ANDA)
|
Mylan Pharmaceuticals Inc. |
saxagliptin and metformin |
D10263
|
cilostazol tablet 50 mg (ANDA)
cilostazol tablet 100 mg (ANDA)
|
Apotex Corp. |
cilostazol |
D01896
|
|
Dextrose and Sodium Chloride injection, solution 5 g00mL (ANDA)
|
Fresenius Kabi USA, LLC |
DEXTROSE MONOHYDRATE and SODIUM CHLORIDE |
|
|
NEUROLITE kit (NDA)
|
SHINE SPECT USA, LLC |
Bicisate dihydrochloride |
|
Carbamazepine capsule, extended release 100 mg (ANDA)
Carbamazepine capsule, extended release 200 mg (ANDA)
Carbamazepine capsule, extended release 300 mg (ANDA)
|
Apotex Corp. |
Carbamazepine |
D00252
|
Tizanidine tablet 2 mg (ANDA)
Tizanidine tablet 4 mg (ANDA)
|
NorthStar Rx LLC |
Tizanidine |
D00776
|
Buspirone Hydrochloride tablet 5 mg (ANDA)
Buspirone Hydrochloride tablet 10 mg (ANDA)
|
Cardinal Health 107, LLC |
buspirone hydrochloride |
D00702
|
|
Succinylcholine Chloride injection, solution 20 mg/mL (ANDA)
|
REMEDYREPACK INC. |
Succinylcholine Chloride |
D00766
|
Otezla tablet, film coated 30 mg (NDA)
Otezla kit (NDA)
Otezla tablet, film coated 20 mg (NDA)
Otezla tablet, film coated 75 mg (NDA)
|
Amgen, Inc |
apremilast |
D08860
|
|
Glycopyrrolate tablet 1 mg (ANDA)
|
Bryant Ranch Prepack |
glycopyrrolate |
D00540
|
|
Prednisone tablet 1 mg (ANDA)
|
Bryant Ranch Prepack |
Prednisone |
D00473
|
|
Clonidine Hydrochloride tablet .1 mg (ANDA)
|
REMEDYREPACK INC. |
Clonidine Hydrochloride |
D00604
|
Imatinib Mesylate tablet, film coated 100 mg (ANDA)
Imatinib Mesylate tablet, film coated 400 mg (ANDA)
|
Apotex Corp |
Imatinib Mesylate |
D01441
|
|
Metformin tablet, extended release 500 mg (ANDA)
|
REMEDYREPACK INC. |
Metformin ER 500 mg |
D00944
|
|
DAPAGLIFLOZIN tablet, film coated 10 mg (ANDA)
|
Bryant Ranch Prepack |
DAPAGLIFLOZIN |
D08897
|
Eltrombopag tablet, film coated 12.5 mg (ANDA)
Eltrombopag tablet, film coated 25 mg (ANDA)
Eltrombopag tablet, film coated 50 mg (ANDA)
Eltrombopag tablet, film coated 75 mg (ANDA)
|
Biocon Pharma Inc. |
Eltrombopag |
D03978
|
|
Bendamustine Hydrochloride injection, solution 25 mg/mL (NDA)
|
Apotex Corp |
Bendamustine Hydrochloride |
D07085
|
|
SPIRONOLACTONE tablet, film coated 100 mg (ANDA)
|
Bryant Ranch Prepack |
SPIRONOLACTONE |
D00443
|
Propranolol Hydrochloride tablet 10 mg (ANDA)
Propranolol Hydrochloride tablet 20 mg (ANDA)
Propranolol Hydrochloride tablet 40 mg (ANDA)
Propranolol Hydrochloride tablet 60 mg (ANDA)
Propranolol Hydrochloride tablet 80 mg (ANDA)
|
Par Health USA, LLC |
propranolol hydrochloride |
D00483
|
|
Amlodipine Besylate and Benazepril Hydrochloride capsule 10 mg (ANDA)
|
REMEDYREPACK INC. |
Amlodipine Besylate and Benazepril Hydrochloride |
D11069
|