ANDA 083722

INTL MEDICATION

FDA Drug Application

Application #083722

Documents

• Review: 2021-09-24
• Review: 2021-09-24

Application Sponsors

ANDA 083722

INTL MEDICATION

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

1MG/0.5ML

0

PHYTONADIONE

PHYTONADIONE

FDA Submissions

	ORIG	1	AP	1976-03-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2000-07-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1987-08-05
LABELING; Labeling	SUPPL	11	AP	1992-12-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1993-08-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1993-10-29
LABELING; Labeling	SUPPL	14	AP	1994-02-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1998-01-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1994-06-17
LABELING; Labeling	SUPPL	18	AP	1994-11-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1995-09-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	2001-01-04
LABELING; Labeling	SUPPL	21	AP	2002-03-06
LABELING; Labeling	SUPPL	23	AP	2003-04-18

Submissions Property Types

SUPPL	5	Null	0
SUPPL	9	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0

TE Codes

001

Prescription

BP

CDER Filings

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(
    [0] => Array
        (
            [ApplNo] => 83722
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)