Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | SOLUTION;INTRAVENOUS, INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUS | EQ 1MG BASE/ML (EQ 1MG BASE/ML) | 1 | EPINEPHRINE | EPINEPHRINE |
| 002 | SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | 10MG/10ML (1MG/ML) | 1 | EPINEPHRINE | EPINEPHRINE |
FDA Submissions
| TYPE 7; Type 7 - Drug Already Marketed without Approved NDA | ORIG | 1 | AP | 2014-07-29 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 2 | AP | 2016-02-11 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 2015-12-03 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2016-05-18 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 6 | AP | 2021-09-10 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2021-06-23 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 6 |
| SUPPL | 2 | Null | 6 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 4 | Null | 15 |
| SUPPL | 6 | Null | 31 |
| SUPPL | 8 | Null | 15 |
CDER Filings
BPI LABS
cder:Array
(
[0] => Array
(
[ApplNo] => 205029
[companyName] => BPI LABS
[docInserts] => ["",""]
[products] => [{"drugName":"EPINEPHRINE","activeIngredients":"EPINEPHRINE","strength":"1MG\/ML (1MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS, INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"EPINEPHRINE","activeIngredients":"EPINEPHRINE","strength":"10MG\/10ML (1MG\/ML)","dosageForm":"SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"09\/10\/2021","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/205029s006lbl.pdf\"}]","notes":""},{"actionDate":"06\/23\/2021","submission":"SUPPL-8","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/205029Orig1s008lbl.pdf\"}]","notes":""},{"actionDate":"06\/23\/2021","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/205029Orig1s008lbl.pdf\"}]","notes":""},{"actionDate":"05\/18\/2016","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/205029s004lbl.pdf\"}]","notes":""},{"actionDate":"02\/11\/2016","submission":"SUPPL-2","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/205029s002lbl.pdf\"}]","notes":""},{"actionDate":"10\/23\/2015","submission":"SUPPL-1","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/205029s001lbl.pdf\"}]","notes":""},{"actionDate":"07\/29\/2014","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/205029s000lbl.pdf\"}]","notes":""}]
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[supplements] => [{"actionDate":"06\/23\/2021","submission":"SUPPL-8","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/205029Orig1s008lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/205029Orig1s008ltr.pdf\"}]","notes":">"},{"actionDate":"09\/10\/2021","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/205029s006lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/205029Orig1s006ltr.pdf\"}]","notes":">"},{"actionDate":"05\/18\/2016","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/205029s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/205029Orig1s004ltr.pdf\"}]","notes":">"},{"actionDate":"12\/03\/2015","submission":"SUPPL-3","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"02\/11\/2016","submission":"SUPPL-2","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/205029s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/205029Orig1s002ltr.pdf\"}]","notes":">"},{"actionDate":"10\/23\/2015","submission":"SUPPL-1","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/205029s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/205029Orig1s001ltr.pdf\"}]","notes":">"}]
[actionDate] => 2021-09-10
)
)