Application Sponsors
| ANDA 091041 | SAGENT PHARMS INC | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | INJECTABLE;INJECTION | EQ 0.2MG BASE/ML | 0 | OCTREOTIDE ACETATE | OCTREOTIDE ACETATE |
| 002 | INJECTABLE;INJECTION | EQ 1MG BASE/ML | 0 | OCTREOTIDE ACETATE | OCTREOTIDE ACETATE |
FDA Submissions
| ORIG | 1 | AP | 2013-11-12 | |
| LABELING; Labeling | SUPPL | 3 | AP | 2017-07-10 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2019-08-27 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 42 |
| SUPPL | 3 | Null | 7 |
| SUPPL | 5 | Null | 7 |
TE Codes
| 001 | Prescription | AP |
| 002 | Prescription | AP |
CDER Filings
SAGENT PHARMS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 91041
[companyName] => SAGENT PHARMS INC
[docInserts] => ["",""]
[products] => [{"drugName":"OCTREOTIDE ACETATE","activeIngredients":"OCTREOTIDE ACETATE","strength":"EQ 0.2MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OCTREOTIDE ACETATE","activeIngredients":"OCTREOTIDE ACETATE","strength":"EQ 1MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"OCTREOTIDE ACETATE","submission":"OCTREOTIDE ACETATE","actionType":"EQ 0.2MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"OCTREOTIDE ACETATE","submission":"OCTREOTIDE ACETATE","actionType":"EQ 1MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)