ANDA 205076

TARO PHARMS

FDA Drug Application

Application #205076

Documents

• Letter: 2016-03-09
• Label: 2016-03-08

Application Sponsors

ANDA 205076

TARO PHARMS

Marketing Status

• Prescription: 001

Application Products

001

CREAM;TOPICAL

EQ 1% BASE

0

OXICONAZOLE NITRATE

OXICONAZOLE NITRATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2016-03-07

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

TARO PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205076
            [companyName] => TARO PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"OXICONAZOLE NITRATE","activeIngredients":"OXICONAZOLE NITRATE","strength":"EQ 1% BASE","dosageForm":"CREAM;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"03\/07\/2016","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/205076Orig1s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"03\/07\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/205076Orig1s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/205076Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2016-03-07
        )

)