ANDA 084094

INTL MEDICATION

FDA Drug Application

Application #084094

Application Sponsors

ANDA 084094

INTL MEDICATION

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

50MG/ML

0

DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE

DIPHENHYDRAMINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1976-03-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1982-03-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1986-11-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1987-02-20
LABELING; Labeling	SUPPL	7	AP	1989-06-30
LABELING; Labeling	SUPPL	8	AP	1993-06-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1993-10-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1998-01-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1994-06-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1995-09-19
LABELING; Labeling	SUPPL	13	AP	1999-12-15
LABELING; Labeling	SUPPL	14	AP	2001-08-03
LABELING; Labeling	SUPPL	15	AP	2005-01-28

Submissions Property Types

SUPPL	2	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 84094
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)