ANDA 090697

ZYDUS PHARMS USA INC

FDA Drug Application

Application #090697

Application Sponsors

ANDA 090697

ZYDUS PHARMS USA INC

Marketing Status

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

Application Products

001	TABLET;ORAL	1.25MG	0	RAMIPRIL	RAMIPRIL
002	TABLET;ORAL	2.5MG	0	RAMIPRIL	RAMIPRIL
003	TABLET;ORAL	5MG	0	RAMIPRIL	RAMIPRIL
004	TABLET;ORAL	10MG	0	RAMIPRIL	RAMIPRIL

FDA Submissions

	ORIG	1	AP	2009-09-24
LABELING; Labeling	SUPPL	2	AP	2014-12-06
LABELING; Labeling	SUPPL	3	AP	2014-12-06

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	7
SUPPL	3	Null	15

CDER Filings

ZYDUS PHARMS USA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90697
            [companyName] => ZYDUS PHARMS USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"RAMIPRIL","activeIngredients":"RAMIPRIL","strength":"1.25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"RAMIPRIL","activeIngredients":"RAMIPRIL","strength":"2.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"RAMIPRIL","activeIngredients":"RAMIPRIL","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"RAMIPRIL","activeIngredients":"RAMIPRIL","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"RAMIPRIL","submission":"RAMIPRIL","actionType":"1.25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"RAMIPRIL","submission":"RAMIPRIL","actionType":"2.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"RAMIPRIL","submission":"RAMIPRIL","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"RAMIPRIL","submission":"RAMIPRIL","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)