| Product |
Company |
Generic name |
KEGG DRUG |
|
Azithromycin Dihydrate tablet, film coated 250 mg (ANDA)
|
A-S Medication Solutions
|
Azithromycin Dihydrate
|
D02134
|
Orapred ODT tablet, orally disintegrating 10 mg (NDA)
Orapred ODT tablet, orally disintegrating 15 mg (NDA)
Orapred ODT tablet, orally disintegrating 30 mg (NDA)
|
Concordia Pharmaceuticals Inc.
|
prednisolone sodium phosphate
|
D00981
|
|
LOCAMETZ injection, powder, lyophilized, for solution 25 ug (NDA)
|
Advanced Accelerator Applications USA, Inc
|
kit for the preparation of gallium Ga 68 gozetotide
|
D12257
|
|
AMLODIPINE BESYLATE tablet 10 mg (ANDA)
|
Legacy Pharmaceutical Packaging, LLC
|
AMLODIPINE BESYLATE
|
D00615
|
Fluoxetine capsule 10 mg (ANDA)
Fluoxetine capsule 20 mg (ANDA)
Fluoxetine capsule 40 mg (ANDA)
|
ScieGen Pharmaceuticals, Inc.
|
Fluoxetine Hydrochloride
|
D00823
|
Fanapt tablet 1 mg (NDA)
Fanapt tablet 2 mg (NDA)
Fanapt tablet 4 mg (NDA)
Fanapt tablet 6 mg (NDA)
Fanapt tablet 8 mg (NDA)
Fanapt tablet 10 mg (NDA)
Fanapt tablet 12 mg (NDA)
Fanapt kit (NDA)
|
Vanda Pharmaceuticals Inc.
|
iloperidone
|
D02666
|
|
Methotrexate injection, solution 25 mg/mL (ANDA)
|
Teva Parenteral Medicines, Inc.
|
Methotrexate
|
D02115
|
|
DIMETHYL FUMARATE capsule, delayed release 240 mg (ANDA)
|
Quallent Pharmaceuticals Health LLC
|
DIMETHYL FUMARATE
|
D03846
|
Piperacillin and Tazobactam injection, powder, lyophilized, for solution 2 g (ANDA)
Piperacillin and Tazobactam injection, powder, lyophilized, for solution 3 g (ANDA)
Piperacillin and Tazobactam injection, powder, lyophilized, for solution 4 g (ANDA)
|
Eugia US LLC
|
Piperacillin Sodium and Tazobactam Sodium
|
D02505
|
RETACRIT injection, solution 2000 [iU]/mL (BLA)
RETACRIT injection, solution 3000 [iU]/mL (BLA)
RETACRIT injection, solution 4000 [iU]/mL (BLA)
RETACRIT injection, solution 10000 [iU]/mL (BLA)
RETACRIT injection, solution 40000 [iU]/mL (BLA)
RETACRIT injection, solution 20000 [iU]/mL (BLA)
|
Pfizer Laboratories Div Pfizer Inc
|
epoetin alfa-epbx
|
D03231
|
Doxycycline tablet 50 mg (ANDA)
Doxycycline tablet 75 mg (ANDA)
Doxycycline tablet 100 mg (ANDA)
Doxycycline tablet 150 mg (ANDA)
|
Strides Pharma Science Limited
|
doxycycline
|
D00307
|
|
Tobramycin Ophthalmic Solution solution/ drops 3 mg/mL (ANDA)
|
Alembic Pharmaceuticals Inc.
|
Tobramycin Ophthalmic Solution
|
D00063
|
Levorphanol Tartrate tablet 2 mg (ANDA)
Levorphanol Tartrate tablet 3 mg (ANDA)
|
Sun Pharmaceutical Industries, Inc.
|
Levorphanol Tartrate
|
D00841
|
|
Heparin Sodium injection, solution 5000 [USP'U]/mL (ANDA)
|
Henry Schein, Inc.
|
Heparin Sodium
|
D02112
|
SELZENTRY tablet, film coated 150 mg (NDA)
SELZENTRY tablet, film coated 300 mg (NDA)
SELZENTRY tablet, film coated 25 mg (NDA)
SELZENTRY tablet, film coated 75 mg (NDA)
SELZENTRY solution 20 mg/mL (NDA)
SELZENTRY kit (NDA)
|
ViiV Healthcare Company
|
maraviroc
|
D06670
|
Amoxicillin and Clavulanate Potassium tablet, film coated 250 mg (ANDA)
Amoxicillin and Clavulanate Potassium tablet, film coated 500 mg (ANDA)
Amoxicillin and Clavulanate Potassium tablet, film coated 875 mg (ANDA)
|
American Health Packaging
|
Amoxicillin and Clavulanate Potassium
|
D06485
|
|
NuvaRing insert, extended release .015 mg/d (NDA)
|
Organon LLC
|
etonogestrel and ethinyl estradiol
|
D11655
|
Omeprazole capsule, delayed release 10 mg (ANDA)
Omeprazole capsule, delayed release 20 mg (ANDA)
Omeprazole capsule, delayed release 40 mg (ANDA)
|
Dr. Reddy's Laboratories Limited
|
Omeprazole
|
D00455
|
|
Midodrine Hydrochloride tablet 5 mg (ANDA)
|
Cardinal Health 107, LLC
|
midodrine hydrochloride
|
D01307
|
|
Hydroxychloroquine sulfate tablet, film coated 200 mg (ANDA)
|
Cardinal Health 107, LLC
|
Hydroxychloroquine sulfate
|
D02114
|
|
Hydrocodone Bitartrate and Acetaminophen tablet 325 mg (ANDA)
|
Bryant Ranch Prepack
|
Hydrocodone Bitartrate and Acetaminophen
|
D00846
|
CARBAMAZEPINE tablet, extended release 200 mg (ANDA)
CARBAMAZEPINE tablet, extended release 400 mg (ANDA)
|
American Health Packaging
|
CARBAMAZEPINE
|
D00252
|
|
Levetiracetam tablet, film coated 750 mg (ANDA)
|
REMEDYREPACK INC.
|
Levetiracetam
|
D00709
|
|
Divalproex sodium tablet, film coated, extended release 250 mg (ANDA)
|
REMEDYREPACK INC.
|
Divalproex sodium
|
D00304
|
|
Acetaminophen and Codeine Phosphate tablet 300 mg (ANDA)
|
NuCare Pharmaceuticals,Inc.
|
Acetaminophen and Codeine Phosphate
|
D02146
|
|
Atenolol tablet 100 mg (ANDA)
|
NuCare Pharmaceuticals,Inc.
|
Atenolol
|
D00235
|
|
Penicillin V Potassium tablet, film coated 250 mg (ANDA)
|
NuCare Pharmaceuticals,Inc.
|
Penicillin V Potassium
|
D00497
|
|
Metoprolol Tartrate tablet, film coated 50 mg (ANDA)
|
NuCare Pharmaceuticals,Inc.
|
Metoprolol Tartrate
|
D00601
|
|
Albuterol Sulfate solution 2.5 mg/3mL (ANDA)
|
NuCare Pharmaceuticals,Inc.
|
Albuterol Sulfate
|
D00683
|
|
topiramate tablet, film coated 50 mg (ANDA)
|
NuCare Pharmaceuticals,Inc.
|
topiramate
|
D00537
|
|
Trazodone Hydrochloride tablet 100 mg (ANDA)
|
NuCare Pharmceuticals,Inc.
|
Trazodone Hydrochloride
|
D00820
|
|
Metoprolol Tartrate tablet, film coated 50 mg (ANDA)
|
NuCare Pharmaceuticals,Inc.
|
Metoprolol Tartrate
|
D00601
|
|
Diazepam tablet 5 mg (ANDA)
|
NuCare Pharmaceuticals,Inc.
|
Diazepam
|
D00293
|
|
Gentamicin Sulfate solution 3 mg/mL (ANDA)
|
NuCare Pharmaceuticals,Inc.
|
Gentamicin Sulfate
|
D01063
|
|
Azithromycin powder, for suspension 200 mg/5mL (ANDA)
|
NuCare Pharmaceuticals,Inc.
|
Azithromycin
|
D02134
|
|
GABAPENTIN capsule 300 mg (ANDA)
|
NuCare Pharmaceuticals,Inc.
|
GABAPENTIN
|
D00332
|
|
mupirocin ointment 20 mg/g (ANDA)
|
NuCare Pharmaceuticals,Inc.
|
Mupirocin
|
D01076
|
|
erythromycin solution 20 mg/mL (ANDA)
|
NuCare Pharmaceuticals,Inc.
|
erythromycin
|
D00140
|
|
Amoxicillin powder, for suspension 400 mg/5mL (ANDA)
|
NuCare Pharmaceuticals,Inc.
|
Amoxicillin
|
D00229
|
|
Acyclovir tablet 400 mg (ANDA)
|
NuCare Pharmaceuticals,Inc.
|
Acyclovir
|
D00222
|