| Product |
Company |
Generic name |
KEGG DRUG |
|
ADSOL RED CELL PRESERVATION kit (NDA)
|
Fenwal, Inc. |
anticoagulant citrate phosphate dextrose (cpd) and adsol preservation |
D08745
|
|
ADSOL RED CELL PRESERVATION kit (NDA)
|
Fenwal, Inc. |
anticoagulant citrate phosphate dextrose (cpd) and adsol preservation |
D08745
|
|
ADSOL RED CELL PRESERVATION kit (NDA)
|
Fenwal, Inc. |
anticoagulant citrate phosphate dextrose (cpd) and adsol preservation kit |
D08745
|
|
CPD/ADSOL kit (NDA)
|
Fenwal, Inc. |
anticoagulant citrate phosphate dextrose (cpd) and adsol preservation |
D08745
|
|
Sildenafil tablet, film coated 20 mg (ANDA)
|
Proficient Rx LP |
Sildenafil |
D02229
|
|
ADSOL RED CELL PRESERVATION kit (NDA)
|
Fenwal, Inc. |
anticoagulant citrate phosphate dextrose (cpd) and adsol preservation |
D08745
|
|
Azacitidine injection, powder, lyophilized, for solution 100 mg/50mL (ANDA)
|
Panacea Biotec Limited |
Azacitidine |
D03021
|
|
RUBY-FILL injection, solution 100 mCi (NDA)
|
Jubilant DraxImage Inc., dba Jubilant Radiopharma |
Rubidium Rb 82 |
D05773
|
|
Vancomycin Hydrochloride injection, powder, lyophilized, for solution 100 g (ANDA)
|
SAMSON MEDICAL TECHNOLOGIES LLC |
Vancomycin Hydrochloride |
D00926
|
|
Dexamethasone Sodium Phosphate injection, solution 4 mg/mL (ANDA)
|
Asclemed USA, Inc. |
Dexamethasone Sodium Phosphate |
D00975
|
Febuxostat tablet 40 mg (ANDA)
Febuxostat tablet 80 mg (ANDA)
|
DR REDDY'S LABORATORIES LIMITED |
Febuxostat |
D01206
|
POTASSIUM CHLORIDE solution 20 meq5mL (ANDA)
POTASSIUM CHLORIDE solution 40 meq5mL (ANDA)
|
Lupin Pharmaceuticals,Inc. |
POTASSIUM CHLORIDE |
D02060
|
|
TRIAMCINOLONE ACETONIDE ointment .5 mg/g (ANDA)
|
Cintex Services, LLC |
TRIAMCINOLONE ACETONIDE |
D00983
|
|
Temsirolimus kit (ANDA)
|
Fresenius Kabi USA, LLC |
Temsirolimus |
D06068
|
|
Decitabine injection, powder, lyophilized, for solution 50 mg/20mL (ANDA)
|
Mylan Institutional LLC |
decitabine |
D03665
|
|
Cefoxitin injection, powder, for solution 100 g (ANDA)
|
SAMSON MEDICAL TECHNOLOGIES LLC |
cefoxitin |
D00913
|
|
Amiodarone Hydrochloride injection, solution 50 mg/mL (ANDA)
|
Mylan Institutional LLC |
amiodarone hydrochloride |
D00636
|
|
Dactinomycin injection, powder, lyophilized, for solution .5 mg/mL (ANDA)
|
Meitheal Pharmaceuticals Inc. |
Dactinomycin |
D00214
|
|
Letrozole tablet 2.5 mg (ANDA)
|
Natco Pharma Limited |
Letrozole |
D00964
|
ZOLPIDEM TARTRATE tablet 3.5 mg (ANDA)
ZOLPIDEM TARTRATE tablet 1.75 mg (ANDA)
|
Lupin Pharmaceuticals,Inc. |
zolpidem tartrate |
D00706
|
|
Dicloxacillin Sodium capsule 500 mg (ANDA)
|
Asclemed USA, Inc. |
Dicloxacillin Sodium |
D02137
|
|
Triamterene and Hydrochlorothiazide tablet 50 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC |
Triamterene and Hydrochlorothiazide |
D10269
|
|
Terazosin capsule 1 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC |
Terazosin Hydrochloride |
D11585
|
|
Divalproex sodium tablet, film coated, extended release 500 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC |
Divalproex sodium |
D00304
|
|
Microgestin 24 Fe kit (ANDA)
|
Mayne Pharma Inc. |
Norethindrone acetate/Ethinyl Estradiol and Ferrous Fumarate |
D04483
|
|
Mirtazapine tablet, film coated 15 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC |
Mirtazapine |
D00563
|
|
Extended Phenytoin Sodium capsule 100 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC |
Phenytoin Sodium |
D02103
|
|
mupirocin ointment 20 mg/g (ANDA)
|
Asclemed USA, Inc. |
Mupirocin |
D01076
|
Penicillin G Potassium injection, powder, for solution 5000000 [iU] (ANDA)
Penicillin G Potassium injection, powder, for solution 20000000 [iU] (ANDA)
|
Sandoz Inc |
Penicillin G Potassium |
D01053
|
Fosinopril Sodium and Hydrochlorothiazide tablet 10 mg (ANDA)
Fosinopril Sodium and Hydrochlorothiazide tablet 20 mg (ANDA)
|
CIPLA USA INC. |
Fosinopril Sodium and Hydrochlorothiazide |
D10280
|
|
Finasteride tablet, film coated 5 mg (ANDA)
|
Exelan Pharmaceuticals Inc. |
Finasteride |
D00321
|
|
Acetaminophen and Codeine tablet 300 mg (ANDA)
|
Asclemed USA, Inc. |
Acetaminophen and Codeine |
D02146
|
|
DICLOFENAC SODIUM gel 30 mg/g (ANDA)
|
Asclemed USA, Inc. |
diclofenac sodium |
D00904
|
|
MECLIZINE HYDROCHLORIDE tablet 25 mg (ANDA)
|
Asclemed USA, Inc. |
Meclizine Hydrocloride |
D01317
|
|
Cefazolin injection, powder, for solution 1 g (ANDA)
|
Hospira, Inc |
Cefazolin |
D00905
|
|
Neomycin and Polymyxin B Sulfates and Hydrocortisone solution/ drops 10 mg/mL (ANDA)
|
Asclemed USA, Inc. |
Neomycin Sulfate, Polymyxin B Sulfate, Hydrocortisone |
D11855
|
|
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN tablet, film coated 325 mg (ANDA)
|
Asclemed USA, Inc. |
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN |
D09999
|
|
Lidocaine ointment 50 mg/g (ANDA)
|
Asclemed USA, Inc. |
lidocaine |
D00358
|
|
Phentermine hydrochloride tablet 37.5 mg (ANDA)
|
Asclemed USA, Inc. |
phentermine hydrochloride |
D05459
|
|
Terbinafine tablet 250 mg (ANDA)
|
Cipla USA Inc. |
Terbinafine |
D02219
|