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FDA NDA · NDA203595

SUCLEAR

Sponsor: BRAINTREE LABS

APPLICATION
NDA203595
TYPE
NDA
ORIGINAL APPROVAL
2013-01-18
LATEST ACTION
2013-08-15
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

SUCLEAR · ReferenceDiscontinued
MAGNESIUM SULFATE 1.6GM/BOT,3.13GM/BOT,17.5GM/BOT,N/A,N/A,N/A,N/A, POLYETHYLENE GLYCOL 3350 N/A,N/A,N/A,210GM,0.74GM,2.86GM,5.6GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, POTASSIUM CHLORIDE, POTASSIUM SULFATE, SODIUM BICARBONATE, SODIUM CHLORIDE, SODIUM SULFATE · SOLUTION · ORAL

Approval history

2013-08-15Manufacturing (CMC) · Supplement 2 · standardAP
2013-08-15Manufacturing (CMC) · Supplement 1 · standardAP
2013-01-18Type 4 - New Combination · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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