ANDA 040728

ECI PHARMS LLC

FDA Drug Application

Application #040728

Application Sponsors

ANDA 040728

ECI PHARMS LLC

Marketing Status

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

Application Products

001	TABLET;ORAL	50MG	0	BETHANECHOL CHLORIDE	BETHANECHOL CHLORIDE
002	TABLET;ORAL	5MG	0	BETHANECHOL CHLORIDE	BETHANECHOL CHLORIDE
003	TABLET;ORAL	10MG	0	BETHANECHOL CHLORIDE	BETHANECHOL CHLORIDE
004	TABLET;ORAL	25MG	0	BETHANECHOL CHLORIDE	BETHANECHOL CHLORIDE

FDA Submissions

	ORIG	1	AP	2007-10-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2019-05-08	UNKNOWN

Submissions Property Types

SUPPL

2

Null

15

TE Codes

001	Prescription	AA
002	Prescription	AA
003	Prescription	AA
004	Prescription	AA

CDER Filings

DISCOVERY THERAP

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40728
            [companyName] => DISCOVERY THERAP
            [docInserts] => ["",""]
            [products] => [{"drugName":"BETHANECHOL CHLORIDE","activeIngredients":"BETHANECHOL CHLORIDE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"BETHANECHOL CHLORIDE","activeIngredients":"BETHANECHOL CHLORIDE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"BETHANECHOL CHLORIDE","activeIngredients":"BETHANECHOL CHLORIDE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"BETHANECHOL CHLORIDE","activeIngredients":"BETHANECHOL CHLORIDE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"BETHANECHOL CHLORIDE","submission":"BETHANECHOL CHLORIDE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"BETHANECHOL CHLORIDE","submission":"BETHANECHOL CHLORIDE","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"BETHANECHOL CHLORIDE","submission":"BETHANECHOL CHLORIDE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"BETHANECHOL CHLORIDE","submission":"BETHANECHOL CHLORIDE","actionType":"25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)