Application 209589

Type
NDA
Sponsor
FERRING PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CLENPIQCITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATESOLUTION;ORAL12GM/BOT;3.5GM/BOT;10MG/BOTYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
55566-6700CLENPIQSODIUM PICOSULFATE, MAGNESIUM OXIDE, and ANHYDROUS CITRIC ACIDFerring Pharmaceuticals Inc.NDACurrent
55566-6700CLENPIQSODIUM PICOSULFATE, MAGNESIUM OXIDE, and ANHYDROUS CITRIC ACIDFerring Pharmaceuticals Inc.NDACurrent
55566-6700CLENPIQSODIUM PICOSULFATE, MAGNESIUM OXIDE, and ANHYDROUS CITRIC ACIDFerring Pharmaceuticals Inc.NDACurrent
55566-6700CLENPIQSODIUM PICOSULFATE, MAGNESIUM OXIDE, and ANHYDROUS CITRIC ACIDFerring Pharmaceuticals Inc.NDACurrent
55566-6700CLENPIQSODIUM PICOSULFATE, MAGNESIUM OXIDE, and ANHYDROUS CITRIC ACIDFerring Pharmaceuticals Inc.NDACurrent
55566-6800CLENPIQSODIUM PICOSULFATE, MAGNESIUM OXIDE, and ANHYDROUS CITRIC ACIDFerring Pharmaceuticals Inc.NDACurrent
72032-6700CLENPIQSODIUM PICOSULFATE, MAGNESIUM OXIDE, and ANHYDROUS CITRIC ACIDASM Aerosol-Service AGNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
75327SUPPL 2023-08-31
75326SUPPL 2023-08-31
75320SUPPL 2023-08-30
71982SUPPL2022-08-31
71981SUPPL2022-08-31
71971SUPPL2022-08-31
60642SUPPL2019-10-30
60620SUPPL2019-10-30
60585SUPPL2019-10-30
59655SUPPL2019-08-12
59645SUPPL2019-08-09
55136ORIG2018-08-08
50560ORIG2017-12-01
50522ORIG2017-11-29