ANDA 209784

SANDOZ INC

FDA Drug Application

Application #209784

Documents

• Letter: 2017-09-07

Application Sponsors

ANDA 209784

SANDOZ INC

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;INTRAVENOUS

50MG/ML (50MG/ML)

0

EPHEDRINE SULFATE

EPHEDRINE SULFATE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2017-08-23	STANDARD
LABELING; Labeling	SUPPL	2	AP	2020-11-24	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	7

TE Codes

001

Prescription

AP

CDER Filings

SANDOZ INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209784
            [companyName] => SANDOZ INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"EPHEDRINE SULFATE","activeIngredients":"EPHEDRINE SULFATE","strength":"50MG\/ML (50MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/23\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/209784Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"10\/28\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-10-28
        )

)