ANDA 078832

ZYDUS PHARMS USA

FDA Drug Application

Application #078832

Documents

• Other Important Information from FDA: 2008-09-19

Application Sponsors

ANDA 078832

ZYDUS PHARMS USA

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

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

FDA Submissions

	ORIG	1	AP	2008-09-02
LABELING; Labeling	SUPPL	4	AP	2014-09-26	STANDARD
LABELING; Labeling	SUPPL	6	AP	2014-09-26	STANDARD
LABELING; Labeling	SUPPL	7	AP	2014-09-26	STANDARD
LABELING; Labeling	SUPPL	9	AP	2014-09-26	STANDARD
LABELING; Labeling	SUPPL	13	AP	2016-01-22	STANDARD
LABELING; Labeling	SUPPL	16	AP	2021-04-02	STANDARD
LABELING; Labeling	SUPPL	17	AP	2022-06-30	STANDARD

Submissions Property Types

SUPPL	4	Null	15
SUPPL	6	Null	15
SUPPL	7	Null	15
SUPPL	9	Null	15
SUPPL	13	Null	15
SUPPL	16	Null	7
SUPPL	17	Null	15

TE Codes

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

CDER Filings

ZYDUS PHARMS USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78832
            [companyName] => ZYDUS PHARMS USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"RAMIPRIL","activeIngredients":"RAMIPRIL","strength":"1.25MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"RAMIPRIL","activeIngredients":"RAMIPRIL","strength":"2.5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"RAMIPRIL","activeIngredients":"RAMIPRIL","strength":"5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"RAMIPRIL","activeIngredients":"RAMIPRIL","strength":"10MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"RAMIPRIL","submission":"RAMIPRIL","actionType":"1.25MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"RAMIPRIL","submission":"RAMIPRIL","actionType":"2.5MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"RAMIPRIL","submission":"RAMIPRIL","actionType":"5MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"RAMIPRIL","submission":"RAMIPRIL","actionType":"10MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)