NDA 022087

GALDERMA LABS LP

FDA Drug Application

Application #022087

Documents

• Letter: 2009-01-30
• Review: 2009-08-03
• Label: 2009-02-04
• Summary Review: 2009-08-03
• Letter: 2020-07-20
• Label: 2020-07-23

Application Sponsors

NDA 022087

GALDERMA LABS LP

Marketing Status

• Prescription: 001

Application Products

001

OINTMENT;TOPICAL

3MCG/GM

1

VECTICAL

CALCITRIOL

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2009-01-23	STANDARD
EFFICACY; Efficacy	SUPPL	9	AP	2020-07-17	STANDARD

Submissions Property Types

ORIG	1	Null	6
SUPPL	9	Null	7

CDER Filings

GALDERMA LABS LP

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22087
            [companyName] => GALDERMA LABS LP
            [docInserts] => ["",""]
            [products] => [{"drugName":"VECTICAL","activeIngredients":"CALCITRIOL","strength":"3MCG\/GM","dosageForm":"OINTMENT;TOPICAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"07\/17\/2020","submission":"SUPPL-9","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/022087s009lbl.pdf\"}]","notes":""},{"actionDate":"01\/23\/2009","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/022087lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"VECTICAL","submission":"CALCITRIOL","actionType":"3MCG\/GM","submissionClassification":"OINTMENT;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2020-07-17
        )

)