NDA 020531

GALDERMA LABS LP

FDA Drug Application

Application #020531

Application Sponsors

NDA 020531

GALDERMA LABS LP

Marketing Status

• Prescription: 001

Application Products

001

CREAM;TOPICAL

0.75%

1

METROCREAM

METRONIDAZOLE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form

ORIG

1

AP

1995-09-20

STANDARD

Submissions Property Types

SUPPL

1

Null

0

TE Codes

001

Prescription

AB

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20531
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)