NDA 020222

PHARMACIA UPJOHN

FDA Drug Application

Application #020222

Documents

• Label: 2014-05-28
• Letter: 2014-05-23
• Label: 2017-05-25
• Letter: 2017-05-26

Application Sponsors

NDA 020222

PHARMACIA UPJOHN

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

1GM

1

COLESTID

COLESTIPOL HYDROCHLORIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1994-07-19	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2002-04-12	PRIORITY
LABELING; Labeling	SUPPL	5	AP	2014-05-22	STANDARD
LABELING; Labeling	SUPPL	6	AP	2017-05-25	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	5	Null	7
SUPPL	6	Null	7

TE Codes

001

Prescription

AB

CDER Filings

PFIZER

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20222
            [companyName] => PFIZER
            [docInserts] => ["",""]
            [products] => [{"drugName":"COLESTID","activeIngredients":"COLESTIPOL HYDROCHLORIDE","strength":"1GM","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"05\/25\/2017","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/020222Orig1s006lbl.pdf\"}]","notes":""},{"actionDate":"05\/25\/2017","submission":"SUPPL-6","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/020222Orig1s006lbl.pdf\"}]","notes":""},{"actionDate":"05\/22\/2014","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/017563s023,020222s005lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"COLESTID","submission":"COLESTIPOL HYDROCHLORIDE","actionType":"1GM","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2017-05-25
        )

)