Documents
Application Sponsors
| NDA 050580 | BRISTOL MYERS SQUIBB | |
Marketing Status
| Discontinued | 001 |
| Prescription | 002 |
| Prescription | 003 |
Application Products
| 001 | INJECTABLE;INJECTION | 500MG/VIAL | 0 | AZACTAM | AZTREONAM |
| 002 | INJECTABLE;INJECTION | 1GM/VIAL | 1 | AZACTAM | AZTREONAM |
| 003 | INJECTABLE;INJECTION | 2GM/VIAL | 1 | AZACTAM | AZTREONAM |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1986-12-31 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 8 | AP | 1996-11-01 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 1990-09-18 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 1989-04-10 | PRIORITY |
| LABELING; Labeling | SUPPL | 19 | AP | 1992-06-25 | |
| LABELING; Labeling | SUPPL | 20 | AP | 1991-09-30 | |
| LABELING; Labeling | SUPPL | 21 | AP | 1996-08-20 | |
| LABELING; Labeling | SUPPL | 22 | AP | 1996-08-20 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 1994-05-23 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 1993-02-18 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 25 | AP | 1994-05-23 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 26 | AP | 1996-04-03 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 27 | AP | 1998-07-28 | PRIORITY |
| LABELING; Labeling | SUPPL | 28 | AP | 1999-02-16 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 29 | AP | 1997-06-12 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 30 | AP | 1997-11-07 | PRIORITY |
| LABELING; Labeling | SUPPL | 31 | AP | 1999-02-16 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 32 | AP | 1999-12-29 | PRIORITY |
| LABELING; Labeling | SUPPL | 33 | AP | 2002-03-25 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 34 | AP | 2002-06-24 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 35 | AP | 2002-09-13 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 36 | AP | 2002-11-27 | PRIORITY |
| LABELING; Labeling | SUPPL | 37 | AP | 2004-12-16 | STANDARD |
| LABELING; Labeling | SUPPL | 40 | AP | 2008-01-22 | STANDARD |
| LABELING; Labeling | SUPPL | 42 | 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 | 43 | AP | 2014-09-30 | PRIORITY |
| LABELING; Labeling | SUPPL | 44 | AP | 2018-06-18 | STANDARD |
| LABELING; Labeling | SUPPL | 46 | AP | 2021-04-16 | STANDARD |
Submissions Property Types
| SUPPL | 17 | Null | 0 |
| SUPPL | 18 | Null | 0 |
| SUPPL | 23 | Null | 0 |
| SUPPL | 24 | Null | 0 |
| SUPPL | 25 | Null | 0 |
| SUPPL | 26 | Null | 0 |
| SUPPL | 27 | Null | 0 |
| SUPPL | 29 | Null | 0 |
| SUPPL | 30 | Null | 0 |
| SUPPL | 32 | Null | 0 |
| SUPPL | 34 | Null | 0 |
| SUPPL | 35 | Null | 0 |
| SUPPL | 36 | Null | 0 |
| SUPPL | 42 | Null | 7 |
| SUPPL | 43 | Null | 0 |
| SUPPL | 44 | Null | 6 |
| SUPPL | 46 | Null | 15 |
TE Codes
| 002 | Prescription | AP |
| 003 | Prescription | AP |
CDER Filings
BRISTOL MYERS SQUIBB
cder:Array
(
[0] => Array
(
[ApplNo] => 50580
[companyName] => BRISTOL MYERS SQUIBB
[docInserts] => ["",""]
[products] => [{"drugName":"AZACTAM","activeIngredients":"AZTREONAM","strength":"500MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"AZACTAM","activeIngredients":"AZTREONAM","strength":"1GM\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"AZACTAM","activeIngredients":"AZTREONAM","strength":"2GM\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"06\/18\/2018","submission":"SUPPL-44","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/050580s044lbl.pdf\"}]","notes":""},{"actionDate":"06\/17\/2013","submission":"SUPPL-42","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/050580s042lbl.pdf\"}]","notes":"Please see"},{"actionDate":"01\/22\/2008","submission":"SUPPL-40","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/050580s040,050632s013lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"AZACTAM","submission":"AZTREONAM","actionType":"500MG\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"AZACTAM","submission":"AZTREONAM","actionType":"1GM\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"AZACTAM","submission":"AZTREONAM","actionType":"2GM\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2018-06-18
)
)