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Details for New Drug Application (NDA): 202217

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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.

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 GAVIS Pharmaceuticals, LLC 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)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SOLUTION, TABLET, DELAYED RELEASE;ORALStrength5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM
Approval Date:Aug 20, 2014TE:RLD:Yes


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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