ANDA 207216

AJANTA PHARMA LTD

FDA Drug Application

Application #207216

Application Sponsors

ANDA 207216

AJANTA PHARMA LTD

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	TABLET;ORAL	EQ 5MG BASE;20MG	0	AMLODIPINE AND OLMESARTAN MEDOXOMIL	AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL
002	TABLET;ORAL	EQ 5MG BASE;40MG	0	AMLODIPINE AND OLMESARTAN MEDOXOMIL	AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL
003	TABLET;ORAL	EQ 10MG BASE;20MG	0	AMLODIPINE AND OLMESARTAN MEDOXOMIL	AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL
004	TABLET;ORAL	EQ 10MG BASE;40MG	0	AMLODIPINE AND OLMESARTAN MEDOXOMIL	AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL

FDA Submissions

UNKNOWN;	ORIG	1	AP	2016-10-28	STANDARD
LABELING; Labeling	SUPPL	2	AP	2019-10-24	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB

CDER Filings

AJANTA PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207216
            [companyName] => AJANTA PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMLODIPINE AND OLMESARTAN MEDOXOMIL","activeIngredients":"AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL","strength":"EQ 5MG BASE;20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"AMLODIPINE AND OLMESARTAN MEDOXOMIL","activeIngredients":"AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL","strength":"EQ 5MG BASE;40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"AMLODIPINE AND OLMESARTAN MEDOXOMIL","activeIngredients":"AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL","strength":"EQ 10MG BASE;20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"AMLODIPINE AND OLMESARTAN MEDOXOMIL","activeIngredients":"AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL","strength":"EQ 10MG BASE;40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/28\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"10\/24\/2019","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/24\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-10-24
        )

)