ANDA 200602

BAYSHORE PHARMS LLC

FDA Drug Application

Application #200602

Application Sponsors

ANDA 200602

BAYSHORE PHARMS LLC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	2.5MG	0	METHSCOPOLAMINE BROMIDE	METHSCOPOLAMINE BROMIDE
002	TABLET;ORAL	5MG	0	METHSCOPOLAMINE BROMIDE	METHSCOPOLAMINE BROMIDE

FDA Submissions

N/A; Not Applicable	ORIG	1	AP	2012-09-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2019-04-23	UNKNOWN

Submissions Property Types

ORIG	1	Null	7
SUPPL	5	Null	7

TE Codes

001	Prescription	AA
002	Prescription	AA

CDER Filings

BAYSHORE PHARMS LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 200602
            [companyName] => BAYSHORE PHARMS LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"METHSCOPOLAMINE BROMIDE","activeIngredients":"METHSCOPOLAMINE BROMIDE","strength":"2.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"METHSCOPOLAMINE BROMIDE","activeIngredients":"METHSCOPOLAMINE BROMIDE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/24\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"04\/23\/2019","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-04-23
        )

)