| Product |
Company |
Generic name |
KEGG DRUG |
Promethazine Hydrochloride suppository 12.5 mg (ANDA)
Promethazine Hydrochloride suppository 25 mg (ANDA)
|
Camber Pharmaceuticals, Inc. |
Promethazine Hydrochloride |
D00480
|
Isotretinoin capsule, liquid filled 10 mg (ANDA)
Isotretinoin capsule, liquid filled 20 mg (ANDA)
Isotretinoin capsule, liquid filled 30 mg (ANDA)
|
Mayne Pharma |
Isotretinoin |
D00348
|
|
Hydroxyzine Pamoate capsule 25 mg (ANDA)
|
Proficient Rx LP |
Hydroxyzine Pamoate |
D01096
|
Pemetrexed disodium injection, powder, lyophilized, for solution 1 g/40mL (ANDA)
Pemetrexed disodium injection, powder, lyophilized, for solution 100 mg/4mL (ANDA)
Pemetrexed disodium injection, powder, lyophilized, for solution 500 mg/20mL (ANDA)
|
Dr. Reddys Laboratories Inc |
Pemetrexed disodium |
D03828
|
|
Metformin Hydrochloride tablet 1000 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC |
Metformin Hydrochloride |
D00944
|
|
losartan potassium and hydrochlorothiazide tablet, film coated 25 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC |
losartan potassium and hydrochlorothiazide |
D07895
|
|
Clonazepam tablet .5 mg (ANDA)
|
Proficient Rx LP |
clonazepam |
D00280
|
|
Duloxetine capsule, delayed release 20 mg (ANDA)
|
Proficient Rx LP |
Duloxetine |
D01179
|
|
Hydroxyzine Hydrochloride tablet, film coated 50 mg (ANDA)
|
Proficient Rx LP |
Hydroxyzine Hydrochloride |
D00672
|
Valsartan and Hydrochlorothiazide tablet, film coated 80 mg (ANDA)
Valsartan and Hydrochlorothiazide tablet, film coated 160 mg (ANDA)
Valsartan and Hydrochlorothiazide tablet 160 mg (ANDA)
Valsartan and Hydrochlorothiazide tablet, film coated 320 mg (ANDA)
|
Macleods Pharmaceuticals Limited |
Valsartan and Hydrochlorothiazide |
D09197
|
|
Trimethoprim tablet 100 mg (ANDA)
|
Novitium Pharma LLC |
Trimethoprim |
D00145
|
|
ADSOL RED CELL PRESERVATION kit (NDA)
|
Fenwal, Inc. |
anticoagulant citrate phosphate dextrose (cpd) and adsol preservation |
D08745
|
|
Ceftriaxone Sodium injection, powder, for solution 2 g (ANDA)
|
Proficient Rx LP |
Ceftriaxone Sodium |
D00924
|
|
Rosuvastatin calcium tablet, film coated 20 mg (ANDA)
|
Proficient Rx LP |
Rosuvastatin calcium |
D01915
|
|
Labetalol hydrochloride tablet, film coated 100 mg (ANDA)
|
Proficient Rx LP |
Labetalol hydrochloride |
D00600
|
|
ADSOL RED CELL PRESERVATION kit (NDA)
|
Fenwal, Inc. |
anticoagulant citrate phosphate dextrose (cpd) and adsol preservation |
D08745
|
Cyanocobalamin injection 1000 ug/mL (ANDA)
cyanocobalamin injection 1000 ug/mL (ANDA)
|
Gland Pharma Limited |
Cyanocobalamin |
D00166
|
|
METFORMIN HYDROCHLORIDE tablet 1000 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC |
METFORMIN HYDROCHLORIDE |
D00944
|
|
Rosuvastatin calcium tablet, film coated 10 mg (ANDA)
|
Proficient Rx LP |
Rosuvastatin Calcium |
D01915
|
Piperacillin and Tazobactam injection, powder, lyophilized, for solution 2 g0mL (ANDA)
Piperacillin and Tazobactam injection, powder, lyophilized, for solution 4 g/20mL (ANDA)
Piperacillin and Tazobactam injection, powder, lyophilized, for solution 3 g5mL (ANDA)
|
Fresenius Kabi USA, LLC |
Piperacillin and Tazobactam |
D02505
|
Lamotrigine tablet, orally disintegrating 25 mg (ANDA)
Lamotrigine tablet, orally disintegrating 50 mg (ANDA)
Lamotrigine tablet, orally disintegrating 100 mg (ANDA)
Lamotrigine tablet, orally disintegrating 200 mg (ANDA)
|
ScieGen Pharmaceuticals, Inc. |
Lamotrigine |
D00354
|
|
KETOROLAC TROMETHAMINE tablet 10 mg (ANDA)
|
ATNAHS PHARMA US LIMITED |
KETOROLAC TROMETHAMINE |
D00813
|
|
ADSOL Red Cell Preservation Solution System in Plastic Container (PL 146 Plastic) kit (NDA)
|
Fenwal, Inc. |
Anticoagulant Citrate Phosphate Dextrose (CPD) Solution and ADSOL Preservation Solution |
D08745
|
|
Acetylcysteine injection, solution 200 mg/mL (ANDA)
|
Fresenius Kabi USA, LLC |
Acetylcysteine |
D00221
|
|
Acetylcysteine solution 200 mg/mL (ANDA)
|
Fresenius Kabi USA, LLC |
ACETYLCYSTEINE |
D00221
|
Imipenem and Cilastatin injection, powder, for solution 500 mg/20mL (ANDA)
Imipenem and Cilastatin injection, powder, for solution 250 mg/20mL (ANDA)
|
Fresenius Kabi USA, LLC |
Imipenem and Cilastatin Sodium |
D00344
|
|
Acetylcysteine injection, solution 200 mg/mL (ANDA)
|
Fresenius Kabi USA, LLC |
Acetylcysteine |
D00221
|
|
Amoxicillin capsule 500 mg (ANDA)
|
Asclemed USA, Inc. |
Amoxicillin |
D00229
|
|
TRAMADOL HYDROCHLORIDE tablet, extended release 200 mg (ANDA)
|
Proficient Rx LP |
TRAMADOL HYDROCHLORIDE |
D01355
|
Eszopiclone tablet, film coated 1 mg (ANDA)
Eszopiclone tablet, film coated 2 mg (ANDA)
Eszopiclone tablet, film coated 3 mg (ANDA)
|
Macleods Pharmaceuticals Limited |
Eszopiclone |
D02624
|
|
Anticoagulant Citrate Phosphate Dextrose (CPD) Blood-Pack Units in PL 146 Plastic solution 1.66 g/63mL (NDA)
|
Fenwal, Inc. |
Anticoagulant Citrate Phosphate Dextrose (CPD) |
D02955
|
Eszopiclone tablet, film coated 1 mg (ANDA)
Eszopiclone tablet, film coated 2 mg (ANDA)
Eszopiclone tablet, film coated 3 mg (ANDA)
|
Mylan Pharmaceuticals Inc. |
eszopiclone |
D02624
|
|
Spironolactone tablet, film coated 25 mg (ANDA)
|
Proficient Rx LP |
spironolactone |
D00443
|
|
ATORVASTATIN CALCIUM tablet, film coated 80 mg (ANDA)
|
Proficient Rx LP |
ATORVASTATIN CALCIUM |
D02258
|
|
Oxycodone and Acetaminophen tablet 5 mg (ANDA)
|
Proficient Rx LP |
Oxycodone and Acetaminophen |
D02153
|
|
Anticoagulant Citrate Phosphate Dextrose (CPD) Blood-Pack Units in PL 146 Plastic solution 921 mg/35mL (NDA)
|
Fenwal, Inc. |
Anticoagulant Citrate Phosphate Dextrose (CPD) Solution |
D02955
|
|
CPDA-1 solution 2 g/63mL (NDA)
|
Fenwal, Inc. |
Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1) Solution |
D02954
|
|
Ciprofloxacin HCl Ophthalmic solution 3 mg/mL (ANDA)
|
Altaire Pharmaceuticals Inc. |
Ciprofloxacin Hydrochloride |
D02216
|
|
Ofloxacin ophthalmic solution 3 mg/mL (ANDA)
|
Altaire Pharmaceuticals Inc. |
Ofloxacin |
D00453
|
Piperacillin and Tazobactam injection, powder, lyophilized, for solution 2 g0mL (ANDA)
Piperacillin and Tazobactam injection, powder, lyophilized, for solution 4 g/20mL (ANDA)
Piperacillin and Tazobactam injection, powder, lyophilized, for solution 3 g5mL (ANDA)
|
Fresenius Kabi USA, LLC |
Piperacillin and Tazobactam |
D02505
|