ANDA 075622

ATHENEX INC

FDA Drug Application

Application #075622

Documents

• Letter: 2001-04-16
• Letter: 2004-06-04

Application Sponsors

ANDA 075622

ATHENEX INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

10MG/ML

0

FAMOTIDINE PRESERVATIVE FREE

FAMOTIDINE

FDA Submissions

	ORIG	1	AP	2001-04-16
LABELING; Labeling	SUPPL	5	AP	2008-06-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	2020-09-09
LABELING; Labeling	SUPPL	14	AP	2020-09-09	STANDARD

Submissions Property Types

SUPPL	13	Null	15
SUPPL	14	Null	7

TE Codes

001

Prescription

AP

CDER Filings

ATHENEX INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75622
            [companyName] => ATHENEX INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"FAMOTIDINE PRESERVATIVE FREE","activeIngredients":"FAMOTIDINE","strength":"10MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"FAMOTIDINE PRESERVATIVE FREE","submission":"FAMOTIDINE","actionType":"10MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)