Application Sponsors
Marketing Status
Application Products
001 | POWDER;INTRAVENOUS | 50MG/VIAL | 0 | TIGECYCLINE | TIGECYCLINE |
FDA Submissions
| ORIG | 1 | AP | 2015-05-27 | |
LABELING; Labeling | SUPPL | 2 | AP | 2017-09-29 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 2017-09-29 | |
LABELING; Labeling | SUPPL | 6 | AP | 2020-04-09 | STANDARD |
LABELING; Labeling | SUPPL | 7 | AP | 2020-04-09 | STANDARD |
LABELING; Labeling | SUPPL | 10 | AP | 2021-01-25 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 19 |
SUPPL | 2 | Null | 7 |
SUPPL | 3 | Null | 7 |
SUPPL | 6 | Null | 15 |
SUPPL | 7 | Null | 15 |
SUPPL | 10 | Null | 15 |
TE Codes
CDER Filings
SANDOZ INC
cder:Array
(
[0] => Array
(
[ApplNo] => 91620
[companyName] => SANDOZ INC
[docInserts] => ["",""]
[products] => [{"drugName":"TIGECYCLINE","activeIngredients":"TIGECYCLINE","strength":"50MG\/VIAL","dosageForm":"POWDER;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"TIGECYCLINE","submission":"TIGECYCLINE","actionType":"50MG\/VIAL","submissionClassification":"POWDER;INTRAVENOUS","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)