Marketing-authorisation holder · United States
Novel Labs Inc
14 medicines in 1 country, as authorisation holder.
Medicines
Every medicine in the registers under its name, current ones first.
14 medicines
| Medicine | Substance | Country | Status | Authorised |
|---|---|---|---|---|
| CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY10mg | 5mg · Tablet, chewable | Cetirizine | United States | Marketed | 2008 |
| HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE1.5mg; 5mg · Tablet | Homatropine methylbromide, Hydrocodone | United States | Marketed | 2000 |
| METOCLOPRAMIDE HYDROCHLORIDE10mg base | 5mg base · Tablet, orally disintegrating | Metoclopramide | United States | Marketed | 2014 |
| MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE0.398gm; 1.102gm · Tablet | Sodium phosphate, Dibasic, Anhydrous, Monobasic, Monohydrate | United States | Marketed | 2011 |
| NITROFURANTOIN100mg | 25mg | 50mg · Capsule | Nitrofurantoin, Macrocrystalline | United States | Marketed | 1992 |
| PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE3350 420gm/bot; 1.48gm/bot; 5.72gm/bot; 11.2gm/bot · For solution | Macrogol, Potassium chloride, Bicarbonate, Sodium chloride | United States | Marketed | 2009 |
| PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL5mg,n/a; 3350 n/a,210gm; 0.74gm; 2.86gm; 5.6gm · For solution, tablet, delayed release | Bisacodyl, N/a, Macrogol, Bicarbonate n/a,2.86gm | United States | Not marketed | 2014 |
| PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID4.7gm; 3350 100gm; 1.015gm; 5.9gm; 2.691gm; 7.5gm · For solution | Ascorbic acid, Macrogol, Potassium chloride, Sodium chloride, Sodium sulfate | United States | Marketed | 2012 |
| PHENELZINE SULFATE15mg base · Tablet | Phenelzine | United States | Marketed | 2010 |
| SULFAMETHOPRIM400mg; 80mg · Tablet | Sulfamethoxazole, Trimethoprim | United States | Not marketed | 1985 |
| SULFAMETHOPRIM-DS800mg; 160mg · Tablet | Sulfamethoxazole, Trimethoprim | United States | Not marketed | 1985 |
| TRIMETHOPRIM100MG | 200MG | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · Tablet | Trimethoprim | United States | Marketed | 1982 |
| VORICONAZOLE200mg/5ml · For suspension | Voriconazole | United States | Marketed | 2013 |
| POLYETHYLENE GLYCOL 3350; SODIUM CHLORIDE; SODIUM BICARBONATE; POTASSIUM CHLORIDE; BISACODYL3350 2mg; 5mg · Solution; oral and tablet; delayed release | Macrogol, Sodium chloride, Bicarbonate, Potassium chloride, Bisacodyl | United States | tentative | 2010 |