NDA 018751

ALVOGEN

FDA Drug Application

Application #018751

Documents

• Label: 2014-04-01
• Letter: 2014-04-02
• Label: 2018-02-02
• Letter: 2020-01-22
• Label: 2020-01-22

Application Sponsors

NDA 018751

ALVOGEN

Marketing Status

• Prescription: 001

Application Products

001

CREAM;TOPICAL

1%

1

SPECTAZOLE

ECONAZOLE NITRATE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1982-12-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1985-01-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1985-06-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1986-12-18	STANDARD
LABELING; Labeling	SUPPL	6	AP	1990-04-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1990-03-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1992-09-10	STANDARD
LABELING; Labeling	SUPPL	11	AP	1995-02-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1995-11-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1998-07-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	2001-03-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	2001-04-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	2001-07-11	STANDARD
LABELING; Labeling	SUPPL	23	AP	2014-03-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	2017-09-07	N/A
LABELING; Labeling	SUPPL	25	AP	2020-01-21	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	12	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	23	Null	6
SUPPL	24	Null	6
SUPPL	25	Null	7

TE Codes

001

Prescription

AB

CDER Filings

ALVOGEN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18751
            [companyName] => ALVOGEN
            [docInserts] => ["",""]
            [products] => [{"drugName":"SPECTAZOLE","activeIngredients":"ECONAZOLE NITRATE","strength":"1%","dosageForm":"CREAM;TOPICAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"01\/21\/2020","submission":"SUPPL-25","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/018751s025lbl.pdf\"}]","notes":""},{"actionDate":"09\/07\/2017","submission":"SUPPL-24","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/018751s024lbl.pdf\"}]","notes":""},{"actionDate":"03\/28\/2014","submission":"SUPPL-23","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/018751s023lbledt.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"SPECTAZOLE","submission":"ECONAZOLE NITRATE","actionType":"1%","submissionClassification":"CREAM;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2020-01-21
        )

)