ANDA 091465

SANDOZ INC

FDA Drug Application

Application #091465

Application Sponsors

ANDA 091465

SANDOZ INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)

0

DEXMEDETOMIDINE HYDROCHLORIDE

DEXMEDETOMIDINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2016-06-14
LABELING; Labeling	SUPPL	2	AP	2020-06-22	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15

TE Codes

001

Prescription

AP

CDER Filings

SANDOZ INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91465
            [companyName] => SANDOZ INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DEXMEDETOMIDINE HYDROCHLORIDE","activeIngredients":"DEXMEDETOMIDINE HYDROCHLORIDE","strength":"EQ 200MCG BASE\/2ML (EQ 100MCG BASE\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DEXMEDETOMIDINE HYDROCHLORIDE","submission":"DEXMEDETOMIDINE HYDROCHLORIDE","actionType":"EQ 200MCG BASE\/2ML (EQ 100MCG BASE\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)