ANDA 040874

ZYDUS PHARMS USA INC

FDA Drug Application

Application #040874

Application Sponsors

ANDA 040874

ZYDUS PHARMS USA INC

Marketing Status

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

Application Products

001	TABLET;ORAL	25MG	0	DIPYRIDAMOLE	DIPYRIDAMOLE
002	TABLET;ORAL	50MG	0	DIPYRIDAMOLE	DIPYRIDAMOLE
003	TABLET;ORAL	75MG	0	DIPYRIDAMOLE	DIPYRIDAMOLE

FDA Submissions

	ORIG	1	AP	2008-01-28
LABELING; Labeling	SUPPL	7	AP	2021-01-27	STANDARD
LABELING; Labeling	SUPPL	8	AP	2021-01-27	STANDARD

Submissions Property Types

SUPPL	7	Null	7
SUPPL	8	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

ZYDUS PHARMS USA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40874
            [companyName] => ZYDUS PHARMS USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DIPYRIDAMOLE","activeIngredients":"DIPYRIDAMOLE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DIPYRIDAMOLE","activeIngredients":"DIPYRIDAMOLE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DIPYRIDAMOLE","activeIngredients":"DIPYRIDAMOLE","strength":"75MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DIPYRIDAMOLE","submission":"DIPYRIDAMOLE","actionType":"25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"DIPYRIDAMOLE","submission":"DIPYRIDAMOLE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"DIPYRIDAMOLE","submission":"DIPYRIDAMOLE","actionType":"75MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)