Application Sponsors
ANDA 060733 | PHARMACIA AND UPJOHN | |
Marketing Status
Discontinued | 001 |
Prescription | 002 |
Application Products
001 | INJECTABLE;INJECTION | 10,000 UNITS/VIAL | 0 | BACITRACIN | BACITRACIN |
002 | INJECTABLE;INJECTION | 50,000 UNITS/VIAL | 0 | BACITRACIN | BACITRACIN |
FDA Submissions
| ORIG | 1 | AP | 1948-07-29 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1991-02-20 | |
LABELING; Labeling | SUPPL | 6 | AP | 1994-04-08 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1995-03-10 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1996-09-16 | |
LABELING; Labeling | SUPPL | 9 | AP | 2004-05-05 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1999-12-02 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 2000-04-05 | |
LABELING; Labeling | SUPPL | 12 | AP | 2004-05-05 | |
Submissions Property Types
SUPPL | 5 | Null | 0 |
SUPPL | 7 | Null | 0 |
SUPPL | 8 | Null | 0 |
SUPPL | 10 | Null | 0 |
SUPPL | 11 | Null | 0 |
TE Codes
CDER Filings
PHARMACIA AND UPJOHN
cder:Array
(
[0] => Array
(
[ApplNo] => 60733
[companyName] => PHARMACIA AND UPJOHN
[docInserts] => ["",""]
[products] => [{"drugName":"BACITRACIN","activeIngredients":"BACITRACIN","strength":"10,000 UNITS\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"BACITRACIN","activeIngredients":"BACITRACIN","strength":"50,000 UNITS\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"BACITRACIN","submission":"BACITRACIN","actionType":"10,000 UNITS\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"BACITRACIN","submission":"BACITRACIN","actionType":"50,000 UNITS\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)