NDA 202428

MAYNE PHARMA

FDA Drug Application

Application #202428

Documents

• Letter: 2012-05-16
• Review: 2012-11-05
• Label: 2012-05-15
• Summary Review: 2012-11-05

Application Sponsors

NDA 202428

MAYNE PHARMA

Marketing Status

• Prescription: 001

Application Products

001

AEROSOL, FOAM;TOPICAL

0.1%

1

FABIOR

TAZAROTENE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form

ORIG

1

AP

2012-05-11

STANDARD

Submissions Property Types

ORIG

1

Null

7

CDER Filings

MAYNE PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202428
            [companyName] => MAYNE PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"FABIOR","activeIngredients":"TAZAROTENE","strength":"0.1%","dosageForm":"AEROSOL, FOAM;TOPICAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"05\/11\/2012","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/202428lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"05\/11\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/202428lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/202428s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2012\\\/202428_fabior_toc.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2012\\\/202428Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2012-05-11
        )

)