ANDA 077524

MAYNE PHARMA

FDA Drug Application

Application #077524

Documents

• Letter: 2008-04-15
• Review: 2011-02-15

Application Sponsors

ANDA 077524

MAYNE PHARMA

Marketing Status

• Prescription: 001

Application Products

001

CREAM;TOPICAL

5%

0

FLUOROURACIL

FLUOROURACIL

FDA Submissions

	ORIG	1	AP	2008-04-11
LABELING; Labeling	SUPPL	2	AP	2014-12-29
LABELING; Labeling	SUPPL	12	AP	2022-09-30	STANDARD

Submissions Property Types

SUPPL	2	Null	15
SUPPL	12	Null	7

TE Codes

001

Prescription

AB

CDER Filings

MAYNE PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77524
            [companyName] => MAYNE PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"FLUOROURACIL","activeIngredients":"FLUOROURACIL","strength":"5%","dosageForm":"CREAM;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"FLUOROURACIL","submission":"FLUOROURACIL","actionType":"5%","submissionClassification":"CREAM;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)