ANDA 075988

CHARTWELL RX

FDA Drug Application

Application #075988

Documents

• Review: 2007-07-06

Application Sponsors

ANDA 075988

CHARTWELL RX

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;ORAL

EQ 5MG BASE/5ML

0

PREDNISOLONE SODIUM PHOSPHATE

PREDNISOLONE SODIUM PHOSPHATE

FDA Submissions

	ORIG	1	AP	2004-05-25
LABELING; Labeling	SUPPL	3	AP	2005-06-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2020-03-05	UNKNOWN

Submissions Property Types

SUPPL

6

Null

15

TE Codes

001

Prescription

AA

CDER Filings

CHARTWELL RX

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75988
            [companyName] => CHARTWELL RX
            [docInserts] => ["",""]
            [products] => [{"drugName":"PREDNISOLONE SODIUM PHOSPHATE","activeIngredients":"PREDNISOLONE SODIUM PHOSPHATE","strength":"EQ 5MG BASE\/5ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PREDNISOLONE SODIUM PHOSPHATE","submission":"PREDNISOLONE SODIUM PHOSPHATE","actionType":"EQ 5MG BASE\/5ML","submissionClassification":"SOLUTION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)