ANDA 078202

NEPHRON

FDA Drug Application

Application #078202

Documents

• Review: 2011-12-02

Application Sponsors

ANDA 078202

NEPHRON

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	SUSPENSION;INHALATION	0.25MG/2ML	0	BUDESONIDE	BUDESONIDE
002	SUSPENSION;INHALATION	0.5MG/2ML	0	BUDESONIDE	BUDESONIDE

FDA Submissions

	ORIG	1	AP	2009-03-30
LABELING; Labeling	SUPPL	5	AP	2015-11-30	STANDARD

Submissions Property Types

SUPPL

5

Null

7

TE Codes

001	Prescription	AN
002	Prescription	AN

CDER Filings

NEPHRON

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78202
            [companyName] => NEPHRON
            [docInserts] => ["",""]
            [products] => [{"drugName":"BUDESONIDE","activeIngredients":"BUDESONIDE","strength":"0.25MG\/2ML","dosageForm":"SUSPENSION;INHALATION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"BUDESONIDE","activeIngredients":"BUDESONIDE","strength":"0.5MG\/2ML","dosageForm":"SUSPENSION;INHALATION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"BUDESONIDE","submission":"BUDESONIDE","actionType":"0.25MG\/2ML","submissionClassification":"SUSPENSION;INHALATION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"BUDESONIDE","submission":"BUDESONIDE","actionType":"0.5MG\/2ML","submissionClassification":"SUSPENSION;INHALATION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)