ANDA 075086

AKORN INC

FDA Drug Application

Application #075086

Documents

• Letter: 2004-06-02
• Label: 2004-06-02
• Review: 1998-04-09

Application Sponsors

ANDA 075086

AKORN INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

5MG/ML

0

DILTIAZEM HYDROCHLORIDE

DILTIAZEM HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1998-04-09
LABELING; Labeling	SUPPL	2	AP	2006-07-17
LABELING; Labeling	SUPPL	9	AP	2006-07-17

TE Codes

001

Prescription

AP

CDER Filings

AKORN INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75086
            [companyName] => AKORN INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DILTIAZEM HYDROCHLORIDE","activeIngredients":"DILTIAZEM HYDROCHLORIDE","strength":"5MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"04\/09\/1998","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/98\\\/75086_Diltiazem%20Hydrochloride_prntlbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"DILTIAZEM HYDROCHLORIDE","submission":"DILTIAZEM HYDROCHLORIDE","actionType":"5MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1998-04-09
        )

)