ANDA 076746

PERRIGO PHARMA INTL

FDA Drug Application

Application #076746

Documents

• Letter: 2004-11-19

Application Sponsors

ANDA 076746

PERRIGO PHARMA INTL

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

5MG

0

PILOCARPINE HYDROCHLORIDE

PILOCARPINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2004-11-16
LABELING; Labeling	SUPPL	2	AP	2011-07-25

TE Codes

001

Prescription

AB

CDER Filings

PERRIGO PHARMA INTL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76746
            [companyName] => PERRIGO PHARMA INTL
            [docInserts] => ["",""]
            [products] => [{"drugName":"PILOCARPINE HYDROCHLORIDE","activeIngredients":"PILOCARPINE HYDROCHLORIDE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PILOCARPINE HYDROCHLORIDE","submission":"PILOCARPINE HYDROCHLORIDE","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)