ANDA 204101

EMCURE PHARMS LTD

FDA Drug Application

Application #204101

Application Sponsors

ANDA 204101

EMCURE PHARMS LTD

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

600MG/VIAL

0

RIFAMPIN

RIFAMPIN

FDA Submissions

UNKNOWN;	ORIG	1	AP	2014-08-18
LABELING; Labeling	SUPPL	6	AP	2020-02-11	STANDARD
LABELING; Labeling	SUPPL	7	AP	2020-02-11	STANDARD
LABELING; Labeling	SUPPL	8	AP	2020-02-11	STANDARD
LABELING; Labeling	SUPPL	9	AP	2020-08-25	STANDARD
LABELING; Labeling	SUPPL	10	AP	2021-10-26	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	6	Null	15
SUPPL	7	Null	7
SUPPL	8	Null	7
SUPPL	9	Null	15
SUPPL	10	Null	7

TE Codes

001

Prescription

AP

CDER Filings

EMCURE PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204101
            [companyName] => EMCURE PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"RIFAMPIN","activeIngredients":"RIFAMPIN","strength":"600MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/18\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"08\/25\/2020","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"02\/11\/2020","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert, Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"02\/11\/2020","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert, Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"02\/11\/2020","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-08-25
        )

)