Details for New Drug Application (NDA): 202217

NDA 202217 describes PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL, which is a drug marketed by Novel Labs Inc and is included in one NDA. It is available from one supplier. Additional details are available on the PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL profile page.

The generic ingredient in PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL is bisacodyl; polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the bisacodyl; polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride profile page.

Summary for 202217

Tradename:	PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL
Applicant:	Novel Labs Inc
Ingredient:	bisacodyl; polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride
Patents:	0

Suppliers and Packaging for NDA: 202217

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL	bisacodyl; polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride	FOR SOLUTION, TABLET, DELAYED RELEASE;ORAL	202217	ANDA	Lupin Pharmaceuticals, Inc.	43386-071	43386-071-83	1 KIT in 1 KIT (43386-071-83) * 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK (43386-010-61) * 2 L in 1 BOTTLE (43386-070-17)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	FOR SOLUTION, TABLET, DELAYED RELEASE;ORAL			Strength	5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM
Approval Date:	Aug 20, 2014	TE:		RLD:	No

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