NDA 020901

GALDERMA LABS LP

FDA Drug Application

Application #020901

Documents

• Letter: 2004-05-26
• Label: 2004-05-27
• Review: 1999-07-08
• Letter: 1998-11-24
• Label: 1998-11-24

Application Sponsors

NDA 020901

GALDERMA LABS LP

Marketing Status

• Prescription: 001

Application Products

001

LOTION;TOPICAL

0.75%

1

METROLOTION

METRONIDAZOLE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1998-11-24	STANDARD
LABELING; Labeling	SUPPL	2	AP	2004-05-11	STANDARD
LABELING; Labeling	SUPPL	3	AP	2015-01-07	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	3	Null	15

TE Codes

001

Prescription

AB

CDER Filings

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            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
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            [supplements] => 
            [actionDate] => 0000-00-00
        )

)