Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | INJECTABLE;INJECTION | 10% | 1 | NUTRILIPID 10% | SOYBEAN OIL |
| 002 | INJECTABLE;INJECTION | 20% | 1 | NUTRILIPID 20% | SOYBEAN OIL |
FDA Submissions
| TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | AP | 1993-05-28 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 2014-08-12 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 2015-12-02 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2020-07-14 | STANDARD |
Submissions Property Types
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 10 | Null | 6 |
TE Codes
| 001 | Prescription | AP |
| 002 | Prescription | AP |
CDER Filings
B BRAUN
cder:Array
(
[0] => Array
(
[ApplNo] => 19531
[companyName] => B BRAUN
[docInserts] => ["",""]
[products] => [{"drugName":"NUTRILIPID 10%","activeIngredients":"SOYBEAN OIL","strength":"10%","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"NUTRILIPID 20%","activeIngredients":"SOYBEAN OIL","strength":"20%","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"07\/14\/2020","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/019531s010lbl.pdf\"}]","notes":""},{"actionDate":"08\/12\/2014","submission":"SUPPL-2","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/019531s002lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."}]
[originalApprovals] => [{"actionDate":"NUTRILIPID 10%","submission":"SOYBEAN OIL","actionType":"10%","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"NUTRILIPID 20%","submission":"SOYBEAN OIL","actionType":"20%","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2020-07-14
)
)