ANDA 209600

ACCORD HLTHCARE INC

FDA Drug Application

Application #209600

Application Sponsors

ANDA 209600

ACCORD HLTHCARE INC

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003
• Discontinued: 004

Application Products

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

2018-08-30

STANDARD

Submissions Property Types

ORIG

1

Null

15

CDER Filings

ACCORD HLTHCARE INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209600
            [companyName] => ACCORD HLTHCARE INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMLODIPINE AND OLMESARTAN MEDOXOMIL","activeIngredients":"AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL","strength":"EQ 5MG BASE;20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"AMLODIPINE AND OLMESARTAN MEDOXOMIL","activeIngredients":"AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL","strength":"EQ 10MG BASE;20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"AMLODIPINE AND OLMESARTAN MEDOXOMIL","activeIngredients":"AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL","strength":"EQ 5MG BASE;40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"AMLODIPINE AND OLMESARTAN MEDOXOMIL","activeIngredients":"AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL","strength":"EQ 10MG BASE;40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/30\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-08-30
        )

)