Documents
Application Sponsors
Marketing Status
| Discontinued | 001 |
| Prescription | 002 |
Application Products
| 001 | POWDER;INTRAVENOUS | EQ 250MG BASE/VIAL;250MG/VIAL | 1 | PRIMAXIN | CILASTATIN SODIUM; IMIPENEM |
| 002 | POWDER;INTRAVENOUS | EQ 500MG BASE/VIAL;500MG/VIAL | 1 | PRIMAXIN | CILASTATIN SODIUM; IMIPENEM |
FDA Submissions
| TYPE 1/4; Type 1 - New Molecular Entity and Type 4 - New Combination | ORIG | 1 | AP | 1985-11-26 | PRIORITY |
| LABELING; Labeling | SUPPL | 2 | AP | 1987-10-08 | |
| LABELING; Labeling | SUPPL | 4 | AP | 1987-10-08 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1986-10-29 | PRIORITY |
| LABELING; Labeling | SUPPL | 13 | AP | 1987-10-08 | |
| LABELING; Labeling | SUPPL | 17 | AP | 1988-01-25 | |
| LABELING; Labeling | SUPPL | 18 | AP | 1988-01-11 | |
| LABELING; Labeling | SUPPL | 20 | AP | 1988-05-20 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 1988-06-17 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 1988-12-12 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 1989-03-30 | PRIORITY |
| LABELING; Labeling | SUPPL | 25 | AP | 1990-08-24 | |
| LABELING; Labeling | SUPPL | 26 | AP | 1994-03-07 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 28 | AP | 1991-08-26 | PRIORITY |
| LABELING; Labeling | SUPPL | 33 | AP | 1993-11-04 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 35 | AP | 1992-01-14 | PRIORITY |
| LABELING; Labeling | SUPPL | 36 | AP | 1992-11-23 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 37 | AP | 1992-07-17 | PRIORITY |
| LABELING; Labeling | SUPPL | 38 | AP | 1994-06-24 | |
| LABELING; Labeling | SUPPL | 39 | AP | 1996-09-12 | |
| LABELING; Labeling | SUPPL | 40 | AP | 1993-11-19 | STANDARD |
| LABELING; Labeling | SUPPL | 41 | AP | 1995-03-21 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 42 | AP | 1994-09-27 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 44 | AP | 1995-03-10 | PRIORITY |
| LABELING; Labeling | SUPPL | 45 | AP | 1997-01-09 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 46 | AP | 1996-09-19 | PRIORITY |
| LABELING; Labeling | SUPPL | 47 | AP | 1997-06-30 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 48 | AP | 1998-04-08 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 49 | AP | 1998-07-24 | PRIORITY |
| LABELING; Labeling | SUPPL | 50 | AP | 1999-02-04 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 51 | AP | 1999-07-13 | PRIORITY |
| LABELING; Labeling | SUPPL | 52 | AP | 2000-08-28 | STANDARD |
| LABELING; Labeling | SUPPL | 53 | AP | 2001-11-30 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 54 | AP | 2001-07-23 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 55 | AP | 2001-08-29 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 56 | AP | 2002-05-28 | PRIORITY |
| LABELING; Labeling | SUPPL | 58 | AP | 2003-03-04 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 59 | AP | 2002-07-09 | PRIORITY |
| LABELING; Labeling | SUPPL | 61 | AP | 2004-05-20 | STANDARD |
| LABELING; Labeling | SUPPL | 64 | AP | 2006-08-04 | STANDARD |
| LABELING; Labeling | SUPPL | 65 | AP | 2008-03-28 | STANDARD |
| LABELING; Labeling | SUPPL | 70 | AP | 2008-05-08 | STANDARD |
| LABELING; Labeling | SUPPL | 72 | AP | 2009-08-26 | UNKNOWN |
| LABELING; Labeling | SUPPL | 73 | AP | 2012-04-16 | STANDARD |
| LABELING; Labeling | SUPPL | 74 | AP | 2016-12-16 | 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 | 75 | AP | 2014-08-26 | PRIORITY |
| LABELING; Labeling | SUPPL | 76 | AP | 2014-12-16 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 77 | AP | 2016-02-19 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 78 | AP | 2016-03-11 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 80 | AP | 2018-08-06 | N/A |
| LABELING; Labeling | SUPPL | 81 | AP | 2018-12-12 | STANDARD |
| LABELING; Labeling | SUPPL | 83 | AP | 2022-01-30 | STANDARD |
Submissions Property Types
| SUPPL | 9 | Null | 0 |
| SUPPL | 21 | Null | 0 |
| SUPPL | 22 | Null | 0 |
| SUPPL | 24 | Null | 0 |
| SUPPL | 28 | Null | 0 |
| SUPPL | 35 | Null | 0 |
| SUPPL | 37 | Null | 0 |
| SUPPL | 42 | Null | 0 |
| SUPPL | 44 | Null | 0 |
| SUPPL | 46 | Null | 0 |
| SUPPL | 49 | Null | 0 |
| SUPPL | 51 | Null | 0 |
| SUPPL | 54 | Null | 0 |
| SUPPL | 55 | Null | 0 |
| SUPPL | 56 | Null | 0 |
| SUPPL | 59 | Null | 0 |
| SUPPL | 61 | Null | 9 |
| SUPPL | 72 | Null | 7 |
| SUPPL | 73 | Null | 7 |
| SUPPL | 74 | Null | 15 |
| SUPPL | 75 | Null | 0 |
| SUPPL | 76 | Null | 6 |
| SUPPL | 77 | Null | 0 |
| SUPPL | 78 | Null | 0 |
| SUPPL | 80 | Null | 31 |
| SUPPL | 81 | Null | 7 |
| SUPPL | 83 | Null | 7 |
TE Codes
CDER Filings
cder:Array
(
[0] => Array
(
[ApplNo] => 50587
[companyName] =>
[docInserts] => ["",""]
[products] => []
[labels] =>
[originalApprovals] => []
[supplements] =>
[actionDate] => 0000-00-00
)
)