ANDA 208905

SANDOZ INC

FDA Drug Application

Application #208905

Application Sponsors

ANDA 208905

SANDOZ INC

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	SOLUTION;INTRAVENOUS	10MG/ML (10MG/ML)	0	PHENYLEPHRINE HYDROCHLORIDE	PHENYLEPHRINE HYDROCHLORIDE
002	SOLUTION;INTRAVENOUS	50MG/5ML (10MG/ML)	0	PHENYLEPHRINE HYDROCHLORIDE	PHENYLEPHRINE HYDROCHLORIDE
003	SOLUTION;INTRAVENOUS	100MG/10ML (10MG/ML)	0	PHENYLEPHRINE HYDROCHLORIDE	PHENYLEPHRINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2019-01-31	STANDARD
LABELING; Labeling	SUPPL	2	AP	2020-07-22	STANDARD
LABELING; Labeling	SUPPL	3	AP	2020-07-22	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15
SUPPL	3	Null	15

TE Codes

001	Prescription	AP1
002	Prescription	AP1
003	Prescription	AP1

CDER Filings

SANDOZ INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208905
            [companyName] => SANDOZ INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PHENYLEPHRINE HYDROCHLORIDE","activeIngredients":"PHENYLEPHRINE HYDROCHLORIDE","strength":"10MG\/ML (10MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PHENYLEPHRINE HYDROCHLORIDE","activeIngredients":"PHENYLEPHRINE HYDROCHLORIDE","strength":"50MG\/5ML (10MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PHENYLEPHRINE HYDROCHLORIDE","activeIngredients":"PHENYLEPHRINE HYDROCHLORIDE","strength":"100MG\/10ML (10MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/31\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"07\/22\/2020","submission":"SUPPL-3","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"07\/22\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-07-22
        )

)