ANDA 083051

INTL MEDICATION

FDA Drug Application

Application #083051

Application Sponsors

ANDA 083051

INTL MEDICATION

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

12.5GM/50ML

0

MANNITOL 25%

MANNITOL

FDA Submissions

	ORIG	1	AP	1975-08-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1985-08-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1987-01-29
LABELING; Labeling	SUPPL	11	AP	1992-12-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1992-12-17
LABELING; Labeling	SUPPL	13	AP	1992-12-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1993-10-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1998-01-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1994-06-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1995-09-19

Submissions Property Types

SUPPL	5	Null	0
SUPPL	7	Null	0
SUPPL	12	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0

TE Codes

001

Prescription

AP

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 83051
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)