ColPrep Kit

Product NDC
10702-283
11-digit product format
107020283
Labeler code
10702
Product ID
10702-283_767105a0-65a5-444a-989f-f766b0851c2a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sodium sulfate, potassium sulfate, and magnesium sulfate for oral solution
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
KVK-Tech, Inc.
Application
NDA204553
Marketing category
NDA
Marketing start
2016-12-27
Marketing end
0000-00-00
Substance
SODIUM SULFATE; POTASSIUM SULFATE; MAGNESIUM SULFATE
Active strength
18 g/22.7g; g/22.7g; g/22.7g
Pharmacologic classes
Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record