NDA 204640

PAR STERILE PRODUCTS

FDA Drug Application

Application #204640

Documents

• Letter: 2013-12-20
• Letter: 2015-12-30
• Letter: 2016-05-19
• Summary Review: 2014-03-06
• Label: 2013-12-19
• Label: 2015-12-28
• Label: 2016-05-20
• Review: 2014-03-06
• Label: 2017-08-11
• Letter: 2017-08-15
• Label: 2019-01-30
• Letter: 2019-02-11
• Review: 2019-11-20
• Letter: 2023-01-06
• Label: 2023-01-09

Application Sponsors

NDA 204640

PAR STERILE PRODUCTS

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS

EQ 30MG BASE/30ML (EQ 1MG BASE/ML)

1

ADRENALIN

EPINEPHRINE

FDA Submissions

TYPE 7; Type 7 - Drug Already Marketed without Approved NDA	ORIG	1	AP	2013-12-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2015-12-23	STANDARD
LABELING; Labeling	SUPPL	3	AP	2016-05-18	901 REQUIRED
LABELING; Labeling	SUPPL	8	AP	2017-08-09	STANDARD
EFFICACY; Efficacy	SUPPL	9	AP	2019-01-29	STANDARD
LABELING; Labeling	SUPPL	18	AP	2022-07-06	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	0
SUPPL	3	Null	6
SUPPL	8	Null	15
SUPPL	9	Null	6

TE Codes

001

Prescription

AP

CDER Filings

PAR STERILE PRODUCTS

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            [companyName] => PAR STERILE PRODUCTS
            [docInserts] => ["",""]
            [products] => [{"drugName":"ADRENALIN","activeIngredients":"EPINEPHRINE","strength":"EQ 30MG BASE\/30ML (EQ 1MG BASE\/ML)","dosageForm":"SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"01\/29\/2019","submission":"SUPPL-9","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/204200Orig1s009,204640Orig1s009lbl.pdf\"}]","notes":""},{"actionDate":"08\/09\/2017","submission":"SUPPL-8","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/204200Orig1s007,204640Orig1s008lbl.pdf\"}]","notes":""},{"actionDate":"05\/18\/2016","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/204200s005,204640s003lbl.pdf\"}]","notes":""},{"actionDate":"12\/23\/2015","submission":"SUPPL-2","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/204640s002lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"12\/18\/2013","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/204640s000lbl.pdf\"}]","notes":""}]
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