NDA 021435

DR REDDYS LABS INC

FDA Drug Application

Application #021435

Documents

• Letter: 2003-11-28

Application Sponsors

NDA 021435

DR REDDYS LABS INC

Marketing Status

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

Application Products

001	TABLET;ORAL	2.5MG	0	AMVAZ	AMLODIPINE MALEATE
002	TABLET;ORAL	5MG	0	AMVAZ	AMLODIPINE MALEATE
003	TABLET;ORAL	10MG	0	AMVAZ	AMLODIPINE MALEATE

FDA Submissions

TYPE 2; Type 2 - New Active Ingredient

ORIG

1

AP

2003-10-31

STANDARD

Submissions Property Types

ORIG

1

Null

0

CDER Filings

DR REDDYS LABS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21435
            [companyName] => DR REDDYS LABS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMVAZ","activeIngredients":"AMLODIPINE MALEATE","strength":"2.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"AMVAZ","activeIngredients":"AMLODIPINE MALEATE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"AMVAZ","activeIngredients":"AMLODIPINE MALEATE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"AMVAZ","submission":"AMLODIPINE MALEATE","actionType":"2.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"AMVAZ","submission":"AMLODIPINE MALEATE","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"AMVAZ","submission":"AMLODIPINE MALEATE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)