NDA 019881

PERRIGO PHARMA INTL

FDA Drug Application

Application #019881

Documents

• Letter: 2003-05-30
• Letter: 2003-08-06
• Label: 2003-05-06
• Label: 2003-08-06

Application Sponsors

NDA 019881

PERRIGO PHARMA INTL

Marketing Status

• Discontinued: 001

Application Products

001

CREAM;VAGINAL

2%

0

BUTOCONAZOLE NITRATE

BUTOCONAZOLE NITRATE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1997-02-07	STANDARD
LABELING; Labeling	SUPPL	2	AP	2003-04-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2000-04-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2000-05-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2000-09-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2002-08-02	STANDARD
LABELING; Labeling	SUPPL	9	AP	2003-07-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	2012-08-10	STANDARD

Submissions Property Types

SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	8	Null	0
SUPPL	18	Null	0

CDER Filings

PERRIGO PHARMA INTL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19881
            [companyName] => PERRIGO PHARMA INTL
            [docInserts] => ["",""]
            [products] => [{"drugName":"BUTOCONAZOLE NITRATE","activeIngredients":"BUTOCONAZOLE NITRATE","strength":"2%","dosageForm":"CREAM;VAGINAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"07\/24\/2003","submission":"SUPPL-9","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/19881slr009_gynazole_lbl.pdf\"}]","notes":""},{"actionDate":"04\/30\/2003","submission":"SUPPL-2","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/019881s002lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"BUTOCONAZOLE NITRATE","submission":"BUTOCONAZOLE NITRATE","actionType":"2%","submissionClassification":"CREAM;VAGINAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2003-07-24
        )

)