NDA 022407

THERAVANCE INC

FDA Drug Application

Application #022407

Documents

• Label: 2013-06-25
• Summary Review: 2013-07-03
• Letter: 2013-06-26
• Review: 2013-10-07
• Medication Guide: 2013-06-28

Application Sponsors

NDA 022407

THERAVANCE INC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	INJECTABLE; INJECTION	250MG	0	VIBATIV	TELAVANCIN
002	INJECTABLE; INJECTION	750MG	0	VIBATIV	TELAVANCIN

FDA Submissions

TYPE 9; Type 9 - New Indication Submitted as Distinct NDA, Consolidated with Original NDA after Approval

ORIG

1

AP

2013-06-21

STANDARD

Submissions Property Types

ORIG

1

Null

6

CDER Filings

THERAVANCE INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22407
            [companyName] => THERAVANCE INC
            [docInserts] => ["Medication Guide","http:\/\/www.fda.gov\/downloads\/Drugs\/DrugSafety\/UCM183838.pdf"]
            [products] => [{"drugName":"VIBATIV","activeIngredients":"TELAVANCIN","strength":"250MG","dosageForm":"INJECTABLE; INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"VIBATIV","activeIngredients":"TELAVANCIN","strength":"750MG","dosageForm":"INJECTABLE; INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"06\/21\/2013","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022407s000,022110s003lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"VIBATIV","submission":"TELAVANCIN","actionType":"250MG","submissionClassification":"INJECTABLE; INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"VIBATIV","submission":"TELAVANCIN","actionType":"750MG","submissionClassification":"INJECTABLE; INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2013-06-21
        )

)