| Product |
Company |
Generic name |
KEGG DRUG |
|
DICLEGIS tablet, delayed release 10 mg (NDA)
|
Duchesnay USA, Inc. |
doxylamine succinate and pyridoxine hydrochloride |
D10357
|
|
Amoxicillin tablet, film coated 875 mg (ANDA)
|
NuCare Pharmaceuticals,Inc. |
Amoxicillin |
D00229
|
BUPROPION HYDROCHLORIDE tablet, film coated, extended release 100 mg (ANDA)
BUPROPION HYDROCHLORIDE tablet, film coated, extended release 150 mg (ANDA)
BUPROPION HYDROCHLORIDE tablet, film coated, extended release 200 mg (ANDA)
|
Aurobindo Pharma Limited |
BUPROPION HYDROCHLORIDE |
D00817
|
DULOXETINE HYDROCHLORIDE capsule, delayed release pellets 20 mg (ANDA)
DULOXETINE HYDROCHLORIDE capsule, delayed release pellets 30 mg (ANDA)
DULOXETINE HYDROCHLORIDE capsule, delayed release pellets 60 mg (ANDA)
|
Yaopharma Co., Ltd. |
DULOXETINE HYDROCHLORIDE |
D01179
|
|
MEPSEVII injection 2 mg/mL (BLA)
|
Ultragenyx Pharmaceutical Inc. |
vestronidase alfa |
D11004
|
|
Prednisolone Sodium Phosphate Oral Solution solution 25 mg/5mL (ANDA)
|
BioComp Pharma, Inc. |
Prednisolone Sodium Phosphate |
D00981
|
|
Dalbavancin injection, powder, lyophilized, for solution 500 mg/25mL (ANDA)
|
Meitheal Pharmaceuticals Inc |
Dalbavancin |
D13218
|
CYCLOPHOSPHAMIDE injection, powder, for solution 500 mg/25mL (ANDA)
CYCLOPHOSPHAMIDE injection, powder, for solution 1 g/50mL (ANDA)
CYCLOPHOSPHAMIDE injection, powder, for solution 2 g00mL (ANDA)
|
Baxter Healthcare Corporation |
cyclophosphamide |
D00287
|
|
Combivent Respimat spray, metered 100 ug (NDA)
|
Boehringer Ingelheim Pharmaceuticals, Inc. |
ipratropium bromide and albuterol |
D10256
|
Amitriptyline Hydrochloride tablet, film coated 25 mg (ANDA)
Amitriptyline Hydrochloride tablet, film coated 50 mg (ANDA)
|
American Health Packaging |
Amitriptyline Hydrochloride |
D00809
|
|
Busulfan injection 6 mg/mL (ANDA)
|
Mylan Institutional LLC |
Busulfan |
D00248
|
|
Metronidazole tablet, film coated 500 mg (ANDA)
|
A-S Medication Solutions |
Metronidazole |
D00409
|
|
Cefdinir capsule 300 mg (ANDA)
|
NuCare Pharmaceuticals,Inc. |
Cefdinir |
D00917
|
|
Susvimo injection, solution 100 mg/mL (BLA)
|
Genentech, Inc. |
Ranibizumab |
D05697
|
|
Tacrolimus injection 5 mg/mL (ANDA)
|
Nexus Pharmaceuticals, LLC |
Tacrolimus |
D00107
|
|
Chlordiazepoxide Hydrochloride and Clidinium Bromide capsule 5 mg (ANDA)
|
Misemer Pharmaceuticals, Inc |
Chlordiazepoxide Hydrochloride, Clidinium Bromide |
D10247
|
|
Nitrous Oxide gas 990 mL/L (NDA)
|
Machine & Welding Supply Company dba Arc3 Gases South |
Nitrous Oxide |
D00102
|
|
Carbon Dioxide gas 990 mL/L (NDA)
|
Arcet Equipment Company dba Arc3 Gases North |
Carbon Dioxide |
D00004
|
|
TRIAMCINOLONE ACETONIDE cream 1 mg/g (ANDA)
|
REMEDYREPACK INC. |
triamcinolone acetonide |
D00983
|
Labetalol Hydrochloride tablet 100 mg (ANDA)
Labetalol Hydrochloride tablet 200 mg (ANDA)
Labetalol Hydrochloride tablet 300 mg (ANDA)
|
Chartwell RX, LLC |
Labetalol Hydrochloride |
D00600
|
|
Potassium Chloride Extended-release tablet, extended release 1500 mg (ANDA)
|
REMEDYREPACK INC. |
Potassium Chloride Extended-release |
D02060
|
|
TYENNE injection, solution 162 mg/.9mL (BLA)
|
Fresenius Kabi USA, LLC |
Tocilizumab-aazg |
D02596
|
Tizanidine HCl tablet 4 mg (ANDA)
Tizanidine HCl tablet 2 mg (ANDA)
|
Advanced Rx Pharmacy of Tennessee, LLC |
Tizanidine HCl |
D00776
|
|
Ammonia N 13 injection 260 mCi/mL (ANDA)
|
PETNET Solutions, Inc. |
Ammonia N-13 |
D02915
|
Isosorbide Mononitrate tablet, extended release 30 mg (ANDA)
Isosorbide Mononitrate tablet, extended release 60 mg (ANDA)
Isosorbide Mononitrate tablet, extended release 120 mg (ANDA)
|
Chartwell RX, LLC |
Isosorbide Mononitrate |
D00630
|
|
Ipratropium Bromide and Albuterol Sulfate solution 3 mg/3mL (ANDA)
|
Chartwell RX, LLC |
Ipratropium Bromide and Albuterol Sulfate |
D10256
|
|
NITROUS OXIDE gas 99 L00L (NDA)
|
Spectrum Gas Products, Inc |
NITROUS OXIDE |
D00102
|
Benztropine Mesylate tablet .5 mg (ANDA)
Benztropine Mesylate tablet 1 mg (ANDA)
Benztropine Mesylate tablet 2 mg (ANDA)
|
American Health Packaging |
Benztropine Mesylate |
D00778
|
|
Butorphanol Tartrate spray 10 mg/mL (ANDA)
|
Apotex Corp. |
Butorphanol Tartrate |
D00837
|
|
Pantoprazole Sodium tablet, delayed release 20 mg (ANDA)
|
AvPAK |
Pantoprazole Sodium |
D02593
|
|
Spironolactone tablet, coated 25 mg (ANDA)
|
A-S Medication Solutions |
Spironolactone |
D00443
|
Glycopyrrolate injection .2 mg/mL (ANDA)
Glycopyrrolate injection .4 mg/2mL (ANDA)
Glycopyrrolate injection 1 mg/5mL (ANDA)
Glycopyrrolate injection 4 mg/20mL (ANDA)
|
Amneal Pharmaceuticals LLC |
Glycopyrrolate |
D00540
|
VARENICLINE TARTRATE kit (ANDA)
VARENICLINE tablet, film coated .5 mg (ANDA)
VARENICLINE tablet, film coated 1 mg (ANDA)
|
Lupin Pharmaceuticals, Inc. |
VARENICLINE TARTRATE |
D06282
|
|
Sucralfate suspension 1 g0mL (ANDA)
|
AvKARE |
Sucralfate Oral |
D00446
|
|
Cotellic tablet, film coated 20 mg (NDA)
|
Genentech, Inc. |
COBIMETINIB |
D10615
|
ZYPITAMAG tablet, film coated 2 mg (NDA)
ZYPITAMAG tablet, film coated 4 mg (NDA)
|
Medicure International Inc |
Pitavastatin Magnesium |
D11092
|
|
Doxycycline Hyclate tablet, film coated 100 mg (ANDA)
|
A-S Medication Solutions |
Doxycycline Hyclate |
D02129
|
|
CHLORHEXIDINE GLUCONATE rinse 1.2 mg/mL (ANDA)
|
PAI Holdings, LLC dba PAI Pharma |
CHLORHEXIDINE GLUCONATE |
D00858
|
Procainamide Hydrochloride injection 100 mg/mL (ANDA)
Procainamide Hydrochloride injection 500 mg/mL (ANDA)
|
Nexus Pharmaceuticals LLC |
Procainamide Hydrochloride |
D00477
|
|
Dabigatran Etexilate capsule 150 mg (ANDA)
|
NorthStar RxLLC |
Dabigatran Etexilate |
D07082
|