NDA 207534

ADAMIS PHARMS CORP

FDA Drug Application

Application #207534

Documents

• Label: 2017-06-15
• Letter: 2017-06-16
• Review: 2017-08-23
• Letter: 2018-10-01
• Label: 2018-10-03
• Letter: 2020-08-27
• Letter: 2021-06-30
• Label: 2021-06-30

Application Sponsors

NDA 207534

ADAMIS PHARMS CORP

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	0.3MG/0.3ML (0.3MG/0.3ML)	1	SYMJEPI	EPINEPHRINE
002	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	0.15MG/0.3ML (0.15MG/0.3ML)	1	SYMJEPI	EPINEPHRINE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	2017-06-15	STANDARD
EFFICACY; Efficacy	SUPPL	3	AP	2018-09-27	STANDARD
LABELING; Labeling	SUPPL	8	AP	2020-08-26	STANDARD
LABELING; Labeling	SUPPL	12	AP	2021-06-29	STANDARD

Submissions Property Types

ORIG	1	Null	12
SUPPL	3	Null	7
SUPPL	8	Null	15
SUPPL	12	Null	7

CDER Filings

ADAMIS PHARMS CORP

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207534
            [companyName] => ADAMIS PHARMS CORP
            [docInserts] => ["",""]
            [products] => [{"drugName":"SYMJEPI","activeIngredients":"EPINEPHRINE","strength":"0.3MG\/0.3ML (0.3MG\/0.3ML)","dosageForm":"SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"SYMJEPI","activeIngredients":"EPINEPHRINE","strength":"0.15MG\/0.3ML (0.15MG\/0.3ML)","dosageForm":"SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"06\/29\/2021","submission":"SUPPL-12","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/207534s012lbl.pdf\"}]","notes":""},{"actionDate":"06\/29\/2021","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/207534s012lbl.pdf\"}]","notes":""},{"actionDate":"06\/29\/2021","submission":"SUPPL-12","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/207534s012lbl.pdf\"}]","notes":""},{"actionDate":"09\/27\/2018","submission":"SUPPL-3","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/207534s003lbl.pdf\"}]","notes":""},{"actionDate":"06\/15\/2017","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/207534lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"06\/15\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/207534lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/207534Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2017\\\/207534Orig1s0000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"06\/29\/2021","submission":"SUPPL-12","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/207534s012lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/207534Orig1s012ltr.pdf\"}]","notes":">"},{"actionDate":"08\/26\/2020","submission":"SUPPL-8","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Patient Package Insert, Labeling-Package Insert","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/207534Orig1s008ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"09\/27\/2018","submission":"SUPPL-3","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/207534s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/207534Orig1s003ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2021-06-29
        )

)