FDA.reportPublic FDA data

Application 022372

Type
NDA
Sponsor
BRAINTREE LABS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SUPREP BOWEL PREP KITMAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATESOLUTION;ORAL1.6GM/BOT;3.13GM/BOT;17.5GM/BOTYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10572-012SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATEsodium sulfate, potassium sulfate, magnesium sulfateAffordable Pharmaceuticals, LLCNDACurrent
10572-112SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATEsodium sulfate, potassium sulfate, magnesium sulfateAffordable Pharmaceuticals, LLCNDACurrent
52268-012SUPREP Bowel Prepsodium sulfate, potassium sulfate, magnesium sulfateBraintree Laboratories, Inc.NDACurrent
52268-012SUPREP Bowel Prepsodium sulfate, potassium sulfate, magnesium sulfateBraintree Laboratories, Inc.NDACurrent
52268-112SUPREP Bowel Prepsodium sulfate, potassium sulfate, magnesium sulfateBraintree Laboratories, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84228SUPPL 2025-11-19
84227SUPPL 2025-11-19
84220SUPPL 2025-11-19
64219SUPPL2020-08-06
64210SUPPL2020-08-06
64209SUPPL2020-08-06
29660SUPPL2012-11-06
17302SUPPL2012-11-02
42501ORIG2011-09-16
24291ORIG2011-09-16
7304SUPPL2011-07-12
43856ORIG2010-08-10
38632ORIG2010-08-10
29659ORIG2010-08-10