Application Sponsors
| NDA 050497 | GLAXOSMITHKLINE | |
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
| Discontinued | 003 |
| Discontinued | 004 |
| Discontinued | 005 |
Application Products
| 001 | INJECTABLE;INJECTION | EQ 1GM BASE/VIAL | 0 | TICAR | TICARCILLIN DISODIUM |
| 002 | INJECTABLE;INJECTION | EQ 3GM BASE/VIAL | 0 | TICAR | TICARCILLIN DISODIUM |
| 003 | INJECTABLE;INJECTION | EQ 6GM BASE/VIAL | 0 | TICAR | TICARCILLIN DISODIUM |
| 004 | INJECTABLE;INJECTION | EQ 20GM BASE/VIAL | 0 | TICAR | TICARCILLIN DISODIUM |
| 005 | INJECTABLE;INJECTION | EQ 30GM BASE/VIAL | 0 | TICAR | TICARCILLIN DISODIUM |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1976-11-09 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 33 | AP | 1989-08-30 | STANDARD |
| LABELING; Labeling | SUPPL | 37 | AP | 1992-01-14 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 38 | AP | 1992-01-02 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 39 | AP | 1990-02-26 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 40 | AP | 1992-01-02 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 41 | AP | 1992-05-28 | STANDARD |
| LABELING; Labeling | SUPPL | 42 | AP | 1992-12-30 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 43 | AP | 1993-04-13 | STANDARD |
| LABELING; Labeling | SUPPL | 44 | AP | 1992-12-30 | STANDARD |
| LABELING; Labeling | SUPPL | 45 | AP | 1992-12-30 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 46 | AP | 1992-12-22 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 47 | AP | 1993-04-07 | STANDARD |
| LABELING; Labeling | SUPPL | 49 | AP | 1995-11-09 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 50 | AP | 1994-11-16 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 51 | AP | 1996-02-06 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 52 | AP | 1996-09-04 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 53 | AP | 1997-12-23 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 54 | AP | 1997-08-29 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 55 | AP | 1998-02-05 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 56 | AP | 2001-08-02 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 57 | AP | 2001-08-02 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 58 | AP | 2002-02-08 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 60 | AP | 2003-01-03 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 0 |
| SUPPL | 33 | Null | 0 |
| SUPPL | 37 | Null | 0 |
| SUPPL | 38 | Null | 0 |
| SUPPL | 39 | Null | 0 |
| SUPPL | 40 | Null | 0 |
| SUPPL | 41 | Null | 0 |
| SUPPL | 42 | Null | 0 |
| SUPPL | 43 | Null | 0 |
| SUPPL | 44 | Null | 0 |
| SUPPL | 45 | Null | 0 |
| SUPPL | 46 | Null | 0 |
| SUPPL | 47 | Null | 0 |
| SUPPL | 49 | Null | 0 |
| SUPPL | 50 | Null | 0 |
| SUPPL | 51 | Null | 0 |
| SUPPL | 52 | Null | 0 |
| SUPPL | 53 | Null | 0 |
| SUPPL | 54 | Null | 0 |
| SUPPL | 55 | Null | 0 |
| SUPPL | 56 | Null | 0 |
| SUPPL | 57 | Null | 0 |
| SUPPL | 58 | Null | 0 |
| SUPPL | 60 | Null | 0 |
CDER Filings
GLAXOSMITHKLINE
cder:Array
(
[0] => Array
(
[ApplNo] => 50497
[companyName] => GLAXOSMITHKLINE
[docInserts] => ["",""]
[products] => [{"drugName":"TICAR","activeIngredients":"TICARCILLIN DISODIUM","strength":"EQ 1GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"TICAR","activeIngredients":"TICARCILLIN DISODIUM","strength":"EQ 3GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"TICAR","activeIngredients":"TICARCILLIN DISODIUM","strength":"EQ 6GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"TICAR","activeIngredients":"TICARCILLIN DISODIUM","strength":"EQ 20GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"TICAR","activeIngredients":"TICARCILLIN DISODIUM","strength":"EQ 30GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"TICAR","submission":"TICARCILLIN DISODIUM","actionType":"EQ 1GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"TICAR","submission":"TICARCILLIN DISODIUM","actionType":"EQ 3GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"TICAR","submission":"TICARCILLIN DISODIUM","actionType":"EQ 6GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"TICAR","submission":"TICARCILLIN DISODIUM","actionType":"EQ 20GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"TICAR","submission":"TICARCILLIN DISODIUM","actionType":"EQ 30GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)