ANDA 211793

ALEMBIC PHARMS LTD

FDA Drug Application

Application #211793

Application Sponsors

ANDA 211793

ALEMBIC PHARMS LTD

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

EQ 600MG BASE

0

AZITHROMYCIN

AZITHROMYCIN

FDA Submissions

UNKNOWN;	ORIG	1	AP	2020-01-27	STANDARD
LABELING; Labeling	SUPPL	5	AP	2021-11-22	STANDARD
LABELING; Labeling	SUPPL	9	AP	2022-01-12	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	5	Null	7
SUPPL	9	Null	7

TE Codes

001

Prescription

AB

CDER Filings

ALEMBIC PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211793
            [companyName] => ALEMBIC PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"AZITHROMYCIN","activeIngredients":"AZITHROMYCIN","strength":"EQ 600MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/27\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-01-27
        )

)