ANDA 076963

INNOGENIX

FDA Drug Application

Application #076963

Application Sponsors

ANDA 076963

INNOGENIX

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	5MG	0	PILOCARPINE HYDROCHLORIDE	PILOCARPINE HYDROCHLORIDE
002	TABLET;ORAL	7.5MG	0	PILOCARPINE HYDROCHLORIDE	PILOCARPINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2004-12-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2007-02-27
LABELING; Labeling	SUPPL	5	AP	2008-01-16
LABELING; Labeling	SUPPL	9	AP	2020-08-26	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	9	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

MLV

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76963
            [companyName] => MLV
            [docInserts] => ["",""]
            [products] => [{"drugName":"PILOCARPINE HYDROCHLORIDE","activeIngredients":"PILOCARPINE HYDROCHLORIDE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PILOCARPINE HYDROCHLORIDE","activeIngredients":"PILOCARPINE HYDROCHLORIDE","strength":"7.5MG","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"},{"actionDate":"PILOCARPINE HYDROCHLORIDE","submission":"PILOCARPINE HYDROCHLORIDE","actionType":"7.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)