FDA.reportPublic FDA data

Application 017563

Type
NDA
Sponsor
PHARMACIA UPJOHN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FLAVORED COLESTIDCOLESTIPOL HYDROCHLORIDEGRANULE;ORAL5GM/PACKETYesNo
002FLAVORED COLESTIDCOLESTIPOL HYDROCHLORIDEGRANULE;ORAL5GM/SCOOPFULYesNo
003COLESTIDCOLESTIPOL HYDROCHLORIDEGRANULE;ORAL5GM/SCOOPFULYesNo
004COLESTIDCOLESTIPOL HYDROCHLORIDEGRANULE;ORAL5GM/PACKETYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0009-0260ColestidColestipol HydrochloridePharmacia and Upjohn Company LLCNDACurrent
0009-0260ColestidColestipol HydrochloridePharmacia and Upjohn Company LLCNDACurrent
0009-0260ColestidColestipol HydrochloridePharmacia & Upjohn Company LLCNDACurrent
0009-0260ColestidColestipol HydrochloridePharmacia and Upjohn Company LLCNDACurrent
0009-0370Flavored ColestidColestipol HydrochloridePharmacia and Upjohn Company LLCNDACurrent
0009-0370Flavored ColestidColestipol HydrochloridePharmacia and Upjohn Company LLCNDACurrent
0009-0370Flavored ColestidColestipol HydrochloridePharmacia & Upjohn Company LLCNDACurrent
0009-0370Flavored ColestidColestipol HydrochloridePharmacia and Upjohn Company LLCNDACurrent
59762-0260Colestipol HydrochlorideColestipol HydrochlorideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0260Colestipol HydrochlorideColestipol HydrochlorideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0260Colestipol HydrochlorideColestipol HydrochlorideGreenstone LLCNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
53869SUPPL2018-04-27
33306SUPPL2014-05-28
13853SUPPL2014-05-23