Details for New Drug Application (NDA): 203595
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NDA 203595 describes SUCLEAR, which is a drug marketed by Braintree Labs and is included in one NDA. Additional details are available on the SUCLEAR profile page.
The generic ingredient in SUCLEAR is magnesium sulfate; polyethylene glycol 3350; potassium chloride; potassium sulfate; sodium bicarbonate; sodium chloride; sodium sulfate. There are one hundred and forty-six drug master file entries for this compound. Additional details are available on the magnesium sulfate; polyethylene glycol 3350; potassium chloride; potassium sulfate; sodium bicarbonate; sodium chloride; sodium sulfate profile page.
The generic ingredient in SUCLEAR is magnesium sulfate; polyethylene glycol 3350; potassium chloride; potassium sulfate; sodium bicarbonate; sodium chloride; sodium sulfate. There are one hundred and forty-six drug master file entries for this compound. Additional details are available on the magnesium sulfate; polyethylene glycol 3350; potassium chloride; potassium sulfate; sodium bicarbonate; sodium chloride; sodium sulfate profile page.
Summary for 203595
| Tradename: | SUCLEAR |
| Applicant: | Braintree Labs |
| Ingredient: | magnesium sulfate; polyethylene glycol 3350; potassium chloride; potassium sulfate; sodium bicarbonate; sodium chloride; sodium sulfate |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;ORAL | Strength | 1.6GM/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**Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Jan 18, 2013 | TE: | RLD: | Yes | |||||
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