Documents
Application Sponsors
| NDA 204200 | PAR STERILE PRODUCTS | |
Marketing Status
Application Products
| 001 | SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | EQ 1MG BASE/ML (EQ 1MG BASE/ML) | 1 | ADRENALIN | EPINEPHRINE |
FDA Submissions
| TYPE 7; Type 7 - Drug Already Marketed without Approved NDA | ORIG | 1 | AP | 2012-12-07 | STANDARD |
| EFFICACY; Efficacy | ORIG | 2 | AP | 2012-12-07 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 2015-03-03 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 2016-09-12 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2016-05-18 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 7 | AP | 2017-08-09 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 9 | AP | 2019-01-29 | STANDARD |
| LABELING; Labeling | SUPPL | 18 | AP | 2023-01-06 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| ORIG | 2 | Null | 15 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 5 | Null | 7 |
| SUPPL | 7 | Null | 6 |
| SUPPL | 9 | Null | 7 |
TE Codes
CDER Filings
PAR STERILE PRODUCTS
cder:Array
(
[0] => Array
(
[ApplNo] => 204200
[companyName] => PAR STERILE PRODUCTS
[docInserts] => ["",""]
[products] => [{"drugName":"ADRENALIN","activeIngredients":"EPINEPHRINE","strength":"EQ 1MG BASE\/ML (EQ 1MG BASE\/ML)","dosageForm":"SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS","marketingStatus":"Prescription","te":"None","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-7","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/204200Orig1s007,204640Orig1s008lbl.pdf\"}]","notes":""},{"actionDate":"09\/12\/2016","submission":"SUPPL-4","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/204200Orig1s004lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"05\/18\/2016","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/204200s005,204640s003lbl.pdf\"}]","notes":""},{"actionDate":"12\/07\/2012","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/204200s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"12\/07\/2012","submission":"ORIG-2","actionType":"Approval","submissionClassification":"Efficacy","reviewPriority":"PRIORITY","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/07\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 7 - Drug Already Marketed without Approved NDA","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/204200s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/204200Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2012\\\/204200_adrenalin_toc.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2012\\\/204200Orig1Orig2s000SumR.pdf\"}]","notes":">"}]
[supplements] => [{"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\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/204200Orig1s009,204640Orig1s009ltr.pdf\"}]","notes":">"},{"actionDate":"08\/09\/2017","submission":"SUPPL-7","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/204200Orig1s007,204640Orig1s008lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/204200Orig1s007,204640Orig1s008ltr.pdf\"},{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2017\\\/204200Orig1s007.pdf\"}]","notes":">"},{"actionDate":"05\/18\/2016","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/204200s005,204640s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/204200Orig1s005,204640Orig1s003ltr.pdf\"}]","notes":">"},{"actionDate":"09\/12\/2016","submission":"SUPPL-4","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/204200Orig1s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/204200Orig1s004ltr.pdf\"}]","notes":">"},{"actionDate":"03\/03\/2015","submission":"SUPPL-3","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"07\/31\/2014","submission":"SUPPL-1","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2019-01-29
)
)