ANDA 074617

ATHENEX INC

FDA Drug Application

Application #074617

Application Sponsors

ANDA 074617

ATHENEX INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

5MG/ML

0

DILTIAZEM HYDROCHLORIDE

DILTIAZEM HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1996-02-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1997-04-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2000-03-30
LABELING; Labeling	SUPPL	4	AP	2000-03-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2000-03-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2000-03-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2000-03-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2000-06-28
LABELING; Labeling	SUPPL	9	AP	2000-04-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2001-04-03

Submissions Property Types

SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	10	Null	0

TE Codes

001

Prescription

AP

CDER Filings

ATHENEX INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 74617
            [companyName] => ATHENEX INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DILTIAZEM HYDROCHLORIDE","activeIngredients":"DILTIAZEM HYDROCHLORIDE","strength":"5MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DILTIAZEM HYDROCHLORIDE","submission":"DILTIAZEM HYDROCHLORIDE","actionType":"5MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)