NDA 021216

PARKE DAVIS

FDA Drug Application

Application #021216

Documents

• Letter: 2004-06-10
• Label: 2000-10-12
• Review: 2004-05-06
• Letter: 2000-10-12
• Healthcare Professional Sheet: 2008-02-01

Application Sponsors

NDA 021216

PARKE DAVIS

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION; ORAL

250MG/5ML

0

NEURONTIN

GABAPENTIN

FDA Submissions

TYPE 6; Type 6 - New Indication (no longer used)

ORIG

1

AP

2000-10-12

STANDARD

Submissions Property Types

ORIG

1

Null

8

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21216
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)