FDA.reportPublic FDA data

Application 021881

Type
NDA
Sponsor
SALIX PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MOVIPREPASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATEFOR SOLUTION;ORAL4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GMYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
65649-201MoviPrepPOLYETHYLENE GLYCOL 3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, ASCORBIC ACID, SODIUM ASCORBATESalix Pharmaceuticals, Inc.NDACurrent
65649-201MoviPrepPOLYETHYLENE GLYCOL 3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, ASCORBIC ACID, SODIUM ASCORBATESalix Pharmaceuticals, Inc.NDACurrent
65649-201MoviPrepPOLYETHYLENE GLYCOL 3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, ASCORBIC ACID, SODIUM ASCORBATESalix Pharmaceuticals, Inc.NDACurrent
65649-201MoviPrepPOLYETHYLENE GLYCOL 3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, ASCORBIC ACID, SODIUM ASCORBATESalix Pharmaceuticals, Inc.NDACurrent
65649-201MoviPrepPOLYETHYLENE GLYCOL 3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, ASCORBIC ACID, SODIUM ASCORBATESalix Pharmaceuticals, Inc.NDACurrent
65649-201MoviPrepPOLYETHYLENE GLYCOL 3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, ASCORBIC ACID, SODIUM ASCORBATESalix Pharmaceuticals, Inc.NDACurrent
65649-201MoviPrepPOLYETHYLENE GLYCOL 3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, ASCORBIC ACID, SODIUM ASCORBATESalix Pharmaceuticals, Inc.NDACurrent
65649-201MoviPrepPOLYETHYLENE GLYCOL 3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, ASCORBIC ACID, SODIUM ASCORBATESalix Pharmaceuticals, Inc.NDACurrent
68682-201PEG-3350, Electrolytes, and Ascorbatepolyethylene glycol 3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic AcidOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-201PEG-3350, Electrolytes, and Ascorbatepolyethylene glycol 3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic AcidOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
70740SUPPL2022-04-11
70732SUPPL2022-04-08
67526SUPPL2021-05-18
67525SUPPL2021-05-18
65149SUPPL2020-11-04
60785SUPPL2019-11-06
56828SUPPL2018-12-20
56758SUPPL2018-12-17
56757SUPPL2018-12-17
37820SUPPL2013-12-19
28774SUPPL2013-12-19
23311ORIG2013-09-20
37819SUPPL2013-09-17
28773SUPPL2013-09-13
37818SUPPL2012-08-31
6377SUPPL2012-08-30
6375SUPPL2011-05-03
37816SUPPL2011-04-29
6376SUPPL2010-11-04
37817SUPPL2010-11-02
21856ORIG2008-09-05
28772SUPPL2008-02-07
6374ORIG2006-08-07
37815ORIG2006-08-04