NDA 019737

GALDERMA LABS LP

FDA Drug Application

Application #019737

Documents

• Letter: 2002-06-03

Application Sponsors

NDA 019737

GALDERMA LABS LP

Marketing Status

• Prescription: 001

Application Products

001

GEL;TOPICAL

0.75%

1

METROGEL

METRONIDAZOLE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1988-11-22	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1989-01-19	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1989-06-20	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1990-05-15	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1994-03-24	PRIORITY
LABELING; Labeling	SUPPL	6	AP	1995-08-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2002-06-04	PRIORITY

Submissions Property Types

ORIG	1	Orphan	5
SUPPL	2	Null	14
SUPPL	3	Null	14
SUPPL	4	Null	14
SUPPL	5	Null	14
SUPPL	7	Null	14

TE Codes

001

Prescription

AB

CDER Filings

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    [0] => Array
        (
            [ApplNo] => 19737
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)