ANDA 204147

EMCURE PHARMS LTD

FDA Drug Application

Application #204147

Application Sponsors

ANDA 204147

EMCURE PHARMS LTD

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

EQ 5MG BASE/ML

0

PROCHLORPERAZINE EDISYLATE

PROCHLORPERAZINE EDISYLATE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2013-10-15
LABELING; Labeling	SUPPL	9	AP	2017-02-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	2019-09-09	STANDARD
LABELING; Labeling	SUPPL	25	AP	2020-06-25	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	9	Null	7
SUPPL	21	Null	15
SUPPL	25	Null	7

TE Codes

001

Prescription

AP

CDER Filings

EMCURE PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204147
            [companyName] => EMCURE PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"PROCHLORPERAZINE EDISYLATE","activeIngredients":"PROCHLORPERAZINE EDISYLATE","strength":"EQ 5MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/15\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"06\/25\/2020","submission":"SUPPL-25","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/09\/2019","submission":"SUPPL-21","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"02\/23\/2017","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-06-25
        )

)