ANDA 209042

ALKEM LABS LTD

FDA Drug Application

Application #209042

Application Sponsors

ANDA 209042

ALKEM LABS 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

2017-08-14

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

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

CDER Filings

ALKEM LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209042
            [companyName] => ALKEM LABS 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":"08\/14\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-08-14
        )

)