ANDA 081309

INTL MEDICATION

FDA Drug Application

Application #081309

Application Sponsors

ANDA 081309

INTL MEDICATION

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

10MG/ML

0

MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE

MEPERIDINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1993-08-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1994-04-18
LABELING; Labeling	SUPPL	3	AP	1994-04-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1994-06-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1995-07-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1995-09-19
LABELING; Labeling	SUPPL	7	AP	2016-12-16	STANDARD
LABELING; Labeling	SUPPL	8	AP	2016-12-16	STANDARD
LABELING; Labeling	SUPPL	9	AP	2019-09-27	STANDARD
LABELING; Labeling	SUPPL	10	AP	2019-10-11	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	15
SUPPL	8	Null	15
SUPPL	9	Null	15
SUPPL	10	Null	7

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 81309
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)