ANDA 076075

CHARTWELL RX

FDA Drug Application

Application #076075

Documents

• Label: 2004-04-13
• Letter: 2004-04-13
• Review: 2004-04-13

Application Sponsors

ANDA 076075

CHARTWELL RX

Marketing Status

• Discontinued: 001

Application Products

001

CREAM;TOPICAL

1%

0

ECONAZOLE NITRATE

ECONAZOLE NITRATE

FDA Submissions

	ORIG	1	AP	2002-11-26
LABELING; Labeling	SUPPL	5	AP	2005-05-16
LABELING; Labeling	SUPPL	11	AP	2015-05-29	STANDARD

Submissions Property Types

SUPPL

11

Null

7

CDER Filings

CHARTWELL RX

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76075
            [companyName] => CHARTWELL RX
            [docInserts] => ["",""]
            [products] => [{"drugName":"ECONAZOLE NITRATE","activeIngredients":"ECONAZOLE NITRATE","strength":"1%","dosageForm":"CREAM;TOPICAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"11\/26\/2002","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/anda\\\/2002\\\/76075_Econazole%20Nitrate_Prntlbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ECONAZOLE NITRATE","submission":"ECONAZOLE NITRATE","actionType":"1%","submissionClassification":"CREAM;TOPICAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2002-11-26
        )

)