| Product |
Company |
Generic name |
KEGG DRUG |
|
VALGANCICLOVIR for solution 50 mg/mL (ANDA)
|
airis PHARMA PVT LTD |
valganciclovir |
D03256
|
Irinotecan hydrochloide injection 20 mg/mL (ANDA)
Irinotecan hydrochloride injection 20 mg/mL (ANDA)
|
Gland Pharma Limited |
Irinotecan hydrochloide |
D01061
|
Chloroprocaine Hydrochloride injection, solution 20 mg/mL (ANDA)
Chloroprocaine Hydrochloride injection, solution 30 mg/mL (ANDA)
|
Hikma Pharmaceuticals USA Inc. |
Chloroprocaine Hydrochloride |
D00732
|
|
DECITABINE injection, powder, lyophilized, for solution 50 mg/20mL (ANDA)
|
Nivagen Pharmaceuticals, Inc. |
decitabine |
D03665
|
|
Fludeoxyglucose F 18 injection 300 mCi/mL (ANDA)
|
The University of Utah DBA Cyclotron Radiochemistry Lab / Huntsman Cancer Institute |
Fludeoxyglucose F 18 |
D01843
|
|
ONDANSETRON injection, solution 2 mg/mL (ANDA)
|
Qilu Pharmaceutical Co., Ltd. |
ONDANSETRON |
D00678
|
clindamycin phosphate lotion 10 mg/mL (ANDA)
clindamycin phosphate solution 10 mg/mL (ANDA)
clindamycin phosphate gel 10 mg/g (ANDA)
|
E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. |
clindamycin phosphate |
D01073
|
|
Potassium Chloride tablet, extended release 1500 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC |
potassium chloride |
D02060
|
|
ACETYLCYSTEINE injection 200 mg/mL (ANDA)
|
Indoco Remedies Limited |
ACETYLCYSTEINE |
D00221
|
|
GABAPENTIN tablet 600 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC |
Gabapentin |
D00332
|
|
Cyproheptadine Hydrochloride solution 2 mg/5mL (ANDA)
|
Patrin Pharma, Inc. |
Cyproheptadine Hydrochloride |
D02234
|
Phenylephrine Hydrochloride injection 10 mg/mL (ANDA)
Phenylephrine Hydrochloride injection 50 mg/5mL (ANDA)
Phenylephrine Hydrochloride injection 100 mg0mL (ANDA)
|
Xellia Pharmaceuticals USA LLC |
PHENYLEPHRINE HYDROCHLORIDE |
D00511
|
|
Acetaminophen injection, solution 10 mg/mL (ANDA)
|
Solupharm Pharmazeutische Erzeugnisse GmbH |
ACETAMINOPHEN |
D00217
|
|
Azithromycin tablet, film coated 500 mg (ANDA)
|
Alembic Pharmaceuticals Inc. |
Azithromycin |
D02134
|
ESZOPICLONE tablet, film coated 1 mg (ANDA)
ESZOPICLONE tablet, film coated 2 mg (ANDA)
ESZOPICLONE tablet, film coated 3 mg (ANDA)
|
Aurobindo Pharma Limited |
ESZOPICLONE |
D02624
|
|
apomorphine hydrocloride injection 30 mg/3mL (ANDA)
|
TruPharma, LLC |
APOMORPHINE HYDROCHLORIDE |
D02004
|
|
Enalapril maleate oral solution solution 1 mg/mL (ANDA)
|
Camber Pharmaceuticals, Inc. |
Enalapril maleate |
D00621
|
|
Metformin hydrochloride tablet, extended release 500 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC |
Metformin hydrochloride |
D00944
|
|
Metformin hydrochloride tablet, extended release 500 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC |
Metformin hydrochloride |
D00944
|
Vancomycin Hydrochloride injection, powder, lyophilized, for solution 500 mg0mL (ANDA)
Vancomycin Hydrochloride injection, powder, lyophilized, for solution 1 g/20mL (ANDA)
|
Gland Pharma Limited |
Vancomycin Hydrochloride |
D00926
|
|
Dextrose injection, solution 100 mg/mL (ANDA)
|
Fresenius Kabi USA, LLC |
Dextrose Monohydrate |
D02325
|
|
Haloperidol injection, solution 5 mg/mL (ANDA)
|
Fresenius Kabi USA, LLC |
HALOPERIDOL LACTATE |
D08035
|
|
Sodium Chloride injection, solution 9 mg/mL (NDA)
|
B. Braun Medical Inc. |
Sodium Chloride |
D02056
|
|
Aloprim injection, powder, lyophilized, for solution 500 mg/25mL (NDA)
|
Mylan Institutional LLC |
Allopurinol |
D07564
|
|
Sotalol Hydrochloride tablet 80 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC |
Sotalol Hydrochloride |
D01026
|
|
LISINOPRIL tablet 10 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC |
Lisinopril |
D00362
|
|
Folic Acid injection, solution 5 mg/mL (ANDA)
|
XGen Pharmaceuticals DJB, Inc. |
Folic Acid |
D00070
|
|
OCTREOSCAN kit (NDA)
|
Curium US LLC |
Indium In -111 Pentetreotide |
D02108
|
|
Levetiracetam injection, solution 100 mg/mL (ANDA)
|
Fresenius Kabi USA, LLC |
LEVETIRACETAM |
D00709
|
Timoptic in Ocudose solution 3.4 mg/mL (NDA)
Timoptic in Ocudose solution 6.8 mg/mL (NDA)
|
Bausch & Lomb Incorporated |
Timolol Maleate |
D00603
|
Penicillin V Potassium tablet, film coated 250 mg (ANDA)
Penicillin V Potassium tablet, film coated 500 mg (ANDA)
|
Aurobindo Pharma Limited |
Penicillin V Potassium |
D00497
|
|
Sodium Chloride injection, solution, concentrate 4 meq/mL (ANDA)
|
Fresenius Kabi USA, LLC |
Sodium Chloride |
D02056
|
|
Gatifloxacin solution/ drops 5 mg/mL (ANDA)
|
Sandoz Inc |
gatifloxacin |
D00589
|
|
Cromolyn Sodium solution/ drops 40 mg/mL (ANDA)
|
Sandoz Inc |
Cromolyn Sodium |
D00526
|
|
Neomycin and Polymyxin B Sulfates and Dexamethasone suspension 1 mg/mL (ANDA)
|
Sandoz Inc. |
neomycin sulfate, polymyxin b sulfate and dexamethasone |
D11177
|
|
Carteolol Hydrochloride solution 10 mg/mL (ANDA)
|
Sandoz Inc |
Carteolol Hydrochloride |
D00599
|
|
Cefuroxime injection, powder, for solution 7.5 g (ANDA)
|
Hikma Pharmaceuticals USA Inc. |
Cefuroxime |
D00915
|
RIVASTIGMINE TARTRATE capsule 1.5 mg (ANDA)
RIVASTIGMINE TARTRATE capsule 3 mg (ANDA)
RIVASTIGMINE TARTRATE capsule 4.5 mg (ANDA)
RIVASTIGMINE TARTRATE capsule 6 mg (ANDA)
|
Nivagen Pharmaceuticals, Inc. |
RIVASTIGMINE TARTRATE |
D02558
|
|
Gemfibrozil tablet 600 mg (ANDA)
|
Nivagen Pharmaceuticals, Inc. |
Gemfibrozil |
D00334
|
Albuterol tablet 2 mg (ANDA)
Albuterol tablet 4 mg (ANDA)
|
Nivagen Pharmaceuticals Inc |
albuterol sulfate |
D00683
|