Suclear

NDA 203595, held by Braintree Labs. Magnesium Sulfate; Polyethylene Glycol 3350; Potassium Chloride; Potassium Sulfate; Sodium Bicarbonate; Sodium Chloride; Sodium Sulfate.

As of Nov 13, 2026, NDA 203595 (Suclear), held by Braintree Labs, was first approved by FDA on Jan 18, 2013, with 2 approved supplements and 0 published complete response letters.

First approved: Jan 18, 2013
Review: Standard
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Jan 18, 2013	Original applicationNew combination · Standard review	Approved	Review Summary Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Suclear1.6GM/BOT,3.13GM/BOT,17.5GM/BOT,N/A,N/A,N/A,N/A;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Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · solution;oral	Magnesium Sulfate; Polyethylene Glycol 3350; Potassium Chloride; Potassium Sulfate; Sodium Bicarbonate; Sodium Chloride; Sodium Sulfate	DiscontinuedReference drug

All 3 submissions, including labeling and manufacturing supplements


Aug 15, 2013	Supplement 1Manufacturing · Standard review	Approved	None posted
Aug 15, 2013	Supplement 2Manufacturing · Standard review	Approved	None posted
Jan 18, 2013	Original applicationNew combination · Standard review	Approved	Review Summary Review Letter Label

Identifiers

Application: NDA 203595
Drugs@FDA: Overview at FDA
Company: Braintree Laboratories, Inc.

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters