NDA 021068

VALIDUS PHARMS

FDA Drug Application

Application #021068

Documents

• Label: 1998-11-20
• Letter: 1998-11-20
• Letter: 2002-04-17
• Letter: 2004-07-08
• Review: 1998-11-20

Application Sponsors

NDA 021068

VALIDUS PHARMS

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;ORAL

1MCG/ML

1

ROCALTROL

CALCITRIOL

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1998-11-20	STANDARD
LABELING; Labeling	SUPPL	2	AP	2004-07-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2013-05-15	STANDARD

Submissions Property Types

SUPPL

8

Null

0

TE Codes

001

Prescription

AA

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21068
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)