ANDA 075797

MAYNE PHARMA

FDA Drug Application

Application #075797

Documents

• Letter: 2004-06-18

Application Sponsors

ANDA 075797

MAYNE PHARMA

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	EQ 10MG BASE	0	TAMOXIFEN CITRATE	TAMOXIFEN CITRATE
002	TABLET;ORAL	EQ 20MG BASE	0	TAMOXIFEN CITRATE	TAMOXIFEN CITRATE

FDA Submissions

	ORIG	1	AP	2003-02-20
LABELING; Labeling	SUPPL	2	AP	2005-04-20
LABELING; Labeling	SUPPL	3	AP	2005-08-18
LABELING; Labeling	SUPPL	4	AP	2006-12-01

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

MAYNE PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75797
            [companyName] => MAYNE PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"TAMOXIFEN CITRATE","activeIngredients":"TAMOXIFEN CITRATE","strength":"EQ 10MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TAMOXIFEN CITRATE","activeIngredients":"TAMOXIFEN CITRATE","strength":"EQ 20MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TAMOXIFEN CITRATE","submission":"TAMOXIFEN CITRATE","actionType":"EQ 10MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"TAMOXIFEN CITRATE","submission":"TAMOXIFEN CITRATE","actionType":"EQ 20MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)