ANDA 071135

MAYNE PHARMA

FDA Drug Application

Application #071135

Application Sponsors

ANDA 071135

MAYNE PHARMA

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

5MG

0

DIAZEPAM

DIAZEPAM

FDA Submissions

	ORIG	1	AP	1987-02-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1988-08-11
LABELING; Labeling	SUPPL	4	AP	1988-05-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1990-07-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1990-06-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1991-05-31
LABELING; Labeling	SUPPL	10	AP	1993-07-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1997-10-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	2001-06-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	2001-04-25
LABELING; Labeling	SUPPL	24	AP	2008-08-06
LABELING; Labeling	SUPPL	31	AP	2015-03-09	STANDARD
LABELING; Labeling	SUPPL	35	AP	2021-08-02	STANDARD
LABELING; Labeling	SUPPL	38	AP	2021-08-02	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	11	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	31	Null	15
SUPPL	35	Null	15
SUPPL	38	Null	15

TE Codes

001

Prescription

AB

CDER Filings

MAYNE PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 71135
            [companyName] => MAYNE PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"DIAZEPAM","activeIngredients":"DIAZEPAM","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DIAZEPAM","submission":"DIAZEPAM","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)