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Approved Drug Products containing Prestwick3_000419 listed in the FDA Orange Book. Original Data : FDA Website

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02 2NOVEL LABS INC

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PharmaCompass

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BISACODYL; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE

Brand Name : HALFLYTELY

Dosage Form : FOR SOLUTION, TABLET, DELAYED RELEASE;ORAL

Dosage Strength : 5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM

Approval Date :

Application Number : 21551

RX/OTC/DISCN :

RLD :

TE Code :

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BISACODYL; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE

Brand Name : HALFLYTELY

Dosage Form : FOR SOLUTION, TABLET, DELAYED RELEASE;ORAL

Dosage Strength : 5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 2010-07-16

Application Number : 21551

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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POLYETHYLENE GLYCOL 3350; SODIUM CHLORIDE; SODIUM BICARBONATE; POTASSIUM CHLORIDE; BISACODYL

Brand Name : POLYETHYLENE GLYCOL 3350; SODIUM CHLORIDE; SODIUM BICARBONATE; POTASSIUM CHLORIDE; BISACODYL

Dosage Form : SOLUTION; ORAL AND TABLET; DELAYED RELEASE

Dosage Strength : 2MG; 5MG

Approval Date :

Application Number : 90197

RX/OTC/DISCN :

RLD :

TE Code :

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BISACODYL; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE

Brand Name : PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL

Dosage Form : FOR SOLUTION, TABLET, DELAYED RELEASE;ORAL

Dosage Strength : 5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM

Approval Date : 2014-08-20

Application Number : 202217

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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