ANDA 065501

GLAND PHARMA LTD

FDA Drug Application

Application #065501

Application Sponsors

ANDA 065501

GLAND PHARMA LTD

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

EQ 500MG BASE/VIAL

0

AZITHROMYCIN

AZITHROMYCIN

FDA Submissions

	ORIG	1	AP	2009-11-09
LABELING; Labeling	SUPPL	2	AP	2014-08-25	STANDARD
LABELING; Labeling	SUPPL	4	AP	2015-03-19	STANDARD
LABELING; Labeling	SUPPL	7	AP	2017-01-05	STANDARD
LABELING; Labeling	SUPPL	8	AP	2020-01-27	STANDARD
LABELING; Labeling	SUPPL	9	AP	2020-01-27	STANDARD
LABELING; Labeling	SUPPL	12	AP	2020-01-27	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	7
SUPPL	4	Null	7
SUPPL	7	Null	15
SUPPL	8	Null	15
SUPPL	9	Null	7
SUPPL	12	Null	15

TE Codes

001

Prescription

AP

CDER Filings

GLAND PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 65501
            [companyName] => GLAND PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"AZITHROMYCIN","activeIngredients":"AZITHROMYCIN","strength":"EQ 500MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"AZITHROMYCIN","submission":"AZITHROMYCIN","actionType":"EQ 500MG BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)