ANDA 075792

ATHENEX INC

FDA Drug Application

Application #075792

Documents

• Letter: 2000-08-29

Application Sponsors

ANDA 075792

ATHENEX INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

1MG/ML

0

PROPRANOLOL HYDROCHLORIDE

PROPRANOLOL HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2000-08-29
LABELING; Labeling	SUPPL	2	AP	2002-03-13
LABELING; Labeling	SUPPL	7	AP	2007-05-01
LABELING; Labeling	SUPPL	8	AP	2008-09-09

Submissions Property Types

SUPPL

1

Null

0

TE Codes

001

Prescription

AP

CDER Filings

ATHENEX INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75792
            [companyName] => ATHENEX INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PROPRANOLOL HYDROCHLORIDE","activeIngredients":"PROPRANOLOL HYDROCHLORIDE","strength":"1MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PROPRANOLOL HYDROCHLORIDE","submission":"PROPRANOLOL HYDROCHLORIDE","actionType":"1MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)