FDA.reportPublic FDA data

Application 202511

Type
ANDA
Sponsor
NOVEL LABS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATEMAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATESOLUTION;ORAL1.6GM/BOT;3.13GM/BOT;17.5GM/BOTNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
40032-700SODIUM SULFATE, POTASSIUM SULFATE, MAGNESIUM SULFATEsodium sulfate, potassium sulfate, magnesium sulfateNovel Laboratories, Inc.ANDACurrent
43386-700SODIUM SULFATE, POTASSIUM SULFATE, MAGNESIUM SULFATEsodium sulfate, potassium sulfate, magnesium sulfateLupin Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
59616ORIG2019-08-07
47469ORIG2017-03-06
47435ORIG2017-03-03