ANDA 079197

AKORN INC

FDA Drug Application

Application #079197

Documents

• Review: 2013-01-22

Application Sponsors

ANDA 079197

AKORN INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;IV (INFUSION)

EQ 40MG BASE/VIAL

0

PANTOPRAZOLE SODIUM

PANTOPRAZOLE SODIUM

FDA Submissions

	ORIG	1	AP	2012-11-08
LABELING; Labeling	SUPPL	3	AP	2021-03-17	STANDARD
LABELING; Labeling	SUPPL	4	AP	2021-03-17	STANDARD
LABELING; Labeling	SUPPL	5	AP	2021-03-17	STANDARD
LABELING; Labeling	SUPPL	6	AP	2021-03-17	STANDARD

Submissions Property Types

ORIG	1	Null	19
SUPPL	3	Null	7
SUPPL	4	Null	7
SUPPL	5	Null	15
SUPPL	6	Null	15

TE Codes

001

Prescription

AP

CDER Filings

AKORN INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 79197
            [companyName] => AKORN INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PANTOPRAZOLE SODIUM","activeIngredients":"PANTOPRAZOLE SODIUM","strength":"EQ 40MG BASE\/VIAL","dosageForm":"INJECTABLE;IV (INFUSION)","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PANTOPRAZOLE SODIUM","submission":"PANTOPRAZOLE SODIUM","actionType":"EQ 40MG BASE\/VIAL","submissionClassification":"INJECTABLE;IV (INFUSION)","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)