ANDA 209450

AMNEAL PHARMS NY

FDA Drug Application

Application #209450

Documents

• Letter: 2021-06-15

Application Sponsors

ANDA 209450

AMNEAL PHARMS NY

Marketing Status

• None (Tentative Approval): 001
• None (Tentative Approval): 002

Application Products

001	CAPSULE;ORAL	8MCG	0	LUBIPROSTONE	LUBIPROSTONE
002	CAPSULE;ORAL	24MCG	0	LUBIPROSTONE	LUBIPROSTONE

FDA Submissions

UNKNOWN;	ORIG	1	TA	2019-06-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2022-05-05	STANDARD

Submissions Property Types

ORIG	1	Null	31
SUPPL	2	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

AMNEAL PHARMS NY

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209450
            [companyName] => AMNEAL PHARMS NY
            [docInserts] => ["",""]
            [products] => [{"drugName":"LUBIPROSTONE","activeIngredients":"LUBIPROSTONE","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/19\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-05-19
        )

)