Documents
Application Sponsors
| ANDA 075102 | SAGENT PHARMS INC | |
Marketing Status
Application Products
| 001 | INJECTABLE;INJECTION | 10MG/ML | 0 | PROPOFOL | PROPOFOL |
FDA Submissions
| ORIG | 1 | AP | 1999-01-04 | |
| LABELING; Labeling | SUPPL | 2 | AP | 1999-03-23 | |
| LABELING; Labeling | SUPPL | 3 | AP | 1999-05-14 | |
| LABELING; Labeling | SUPPL | 4 | AP | 2000-02-10 | |
| LABELING; Labeling | SUPPL | 5 | AP | 2000-11-16 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 2002-03-06 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 2002-09-11 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 2002-09-11 | |
| LABELING; Labeling | SUPPL | 9 | AP | 2002-09-11 | |
| LABELING; Labeling | SUPPL | 11 | AP | 2005-02-08 | |
| LABELING; Labeling | SUPPL | 13 | AP | 2005-03-10 | |
| LABELING; Labeling | SUPPL | 14 | AP | 2009-02-25 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 28 | AP | 2012-12-18 | |
| LABELING; Labeling | SUPPL | 32 | AP | 2015-11-19 | STANDARD |
| LABELING; Labeling | SUPPL | 35 | AP | 2016-07-05 | STANDARD |
| LABELING; Labeling | SUPPL | 38 | AP | 2017-12-22 | STANDARD |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 28 | Null | 15 |
| SUPPL | 32 | Null | 7 |
| SUPPL | 35 | Null | 15 |
| SUPPL | 38 | Null | 7 |
TE Codes
CDER Filings
SAGENT PHARMS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 75102
[companyName] => SAGENT PHARMS INC
[docInserts] => ["",""]
[products] => [{"drugName":"PROPOFOL","activeIngredients":"PROPOFOL","strength":"10MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"PROPOFOL","submission":"PROPOFOL","actionType":"10MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)