NDA 212319

RAFA LABS LTD

FDA Drug Application

Application #212319

Documents

• Label: 2018-07-11
• Review: 2018-10-11
• Letter: 2019-07-10
• Label: 2019-07-11

Application Sponsors

NDA 212319

RAFA LABS LTD

Marketing Status

• Discontinued: 001

Application Products

001

SOLUTION;INTRAMUSCULAR

EQ 2MG SULFATE/0.7ML (EQ 2MG SULFATE/0.7ML)

0

ATROPINE (AUTOINJECTOR)

ATROPINE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	2018-07-09	PRIORITY
LABELING; Labeling	SUPPL	2	AP	2019-07-09	STANDARD

Submissions Property Types

ORIG	1	Null	6
SUPPL	2	Null	15

CDER Filings

RAFA LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212319
            [companyName] => RAFA LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ATROPINE (AUTOINJECTOR)","activeIngredients":"ATROPINE","strength":"EQ 2MG SULFATE\/0.7ML (EQ 2MG SULFATE\/0.7ML)","dosageForm":"SOLUTION;INTRAMUSCULAR","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"07\/09\/2019","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/212319s002lbl.pdf\"}]","notes":""},{"actionDate":"07\/09\/2018","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/212319s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"07\/09\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"PRIORITY","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/212319s000lbl.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2018\\\/212319Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"07\/09\/2019","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/212319s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/212319Orig1s002ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2019-07-09
        )

)