ANDA 075733

NOVAST LABS

FDA Drug Application

Application #075733

Documents

• Letter: 2003-12-24
• Label: 2003-12-24
• Review: 2003-12-24

Application Sponsors

ANDA 075733

NOVAST LABS

Marketing Status

• Prescription: 001

Application Products

001

CREAM;TOPICAL

0.05%

0

CLOBETASOL PROPIONATE (EMOLLIENT)

CLOBETASOL PROPIONATE

FDA Submissions

ORIG

1

AP

2001-08-22

TE Codes

001

Prescription

AB2

CDER Filings

ANI PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75733
            [companyName] => ANI PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CLOBETASOL PROPIONATE (EMOLLIENT)","activeIngredients":"CLOBETASOL PROPIONATE","strength":"0.05%","dosageForm":"CREAM;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"08\/22\/2001","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"CLOBETASOL PROPIONATE (EMOLLIENT)","submission":"CLOBETASOL PROPIONATE","actionType":"0.05%","submissionClassification":"CREAM;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2001-08-22
        )

)