Documents
Application Sponsors
| NDA 050632 | BRISTOL MYERS SQUIBB | |
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
| Discontinued | 003 |
Application Products
| 001 | INJECTABLE;INJECTION | 40MG/ML | 1 | AZACTAM IN PLASTIC CONTAINER | AZTREONAM |
| 002 | INJECTABLE;INJECTION | 20MG/ML | 1 | AZACTAM IN PLASTIC CONTAINER | AZTREONAM |
| 003 | INJECTABLE;INJECTION | 10MG/ML | 0 | AZACTAM IN PLASTIC CONTAINER | AZTREONAM |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 1989-05-24 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 1992-06-25 | |
| LABELING; Labeling | SUPPL | 5 | AP | 1991-09-30 | |
| LABELING; Labeling | SUPPL | 6 | AP | 1996-08-20 | |
| LABELING; Labeling | SUPPL | 7 | AP | 1996-08-20 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1996-10-10 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 1999-02-16 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 10 | AP | 1998-12-24 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 2002-03-25 | STANDARD |
| LABELING; Labeling | SUPPL | 12 | AP | 2004-12-16 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 2008-01-22 | STANDARD |
| LABELING; Labeling | SUPPL | 15 | AP | 2013-06-17 | STANDARD Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 2013-07-12 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 2014-07-25 | STANDARD |
| LABELING; Labeling | SUPPL | 19 | AP | 2018-06-18 | STANDARD |
Submissions Property Types
| SUPPL | 8 | Null | 0 |
| SUPPL | 15 | Null | 6 |
| SUPPL | 16 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 19 | Null | 15 |
CDER Filings
BRISTOL MYERS SQUIBB
cder:Array
(
[0] => Array
(
[ApplNo] => 50632
[companyName] => BRISTOL MYERS SQUIBB
[docInserts] => ["",""]
[products] => [{"drugName":"AZACTAM IN PLASTIC CONTAINER","activeIngredients":"AZTREONAM","strength":"40MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"AZACTAM IN PLASTIC CONTAINER","activeIngredients":"AZTREONAM","strength":"20MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"AZACTAM IN PLASTIC CONTAINER","activeIngredients":"AZTREONAM","strength":"10MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"06\/18\/2018","submission":"SUPPL-19","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/050632s019lbl.pdf\"}]","notes":""},{"actionDate":"06\/17\/2013","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/050632s015lbl.pdf\"}]","notes":"Please see"},{"actionDate":"01\/22\/2008","submission":"SUPPL-13","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/050580s040,050632s013lbl.pdf\"}]","notes":""},{"actionDate":"12\/24\/1998","submission":"SUPPL-10","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/1998\\\/50623s10lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"AZACTAM IN PLASTIC CONTAINER","submission":"AZTREONAM","actionType":"40MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"AZACTAM IN PLASTIC CONTAINER","submission":"AZTREONAM","actionType":"20MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"AZACTAM IN PLASTIC CONTAINER","submission":"AZTREONAM","actionType":"10MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 2018-06-18
)
)