Documents
Application Sponsors
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
Application Products
| 001 | INJECTABLE;INJECTION | EQ 250MG BASE/VIAL;250MG/VIAL | 0 | PRIMAXIN | CILASTATIN SODIUM; IMIPENEM |
| 002 | INJECTABLE;INJECTION | EQ 500MG BASE/VIAL;500MG/VIAL | 0 | PRIMAXIN | CILASTATIN SODIUM; IMIPENEM |
FDA Submissions
| ORIG | 1 | AP | 1987-01-08 | |
| LABELING; Labeling | SUPPL | 3 | AP | 1991-03-07 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1991-02-26 | |
| LABELING; Labeling | SUPPL | 5 | AP | 1993-12-29 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1991-09-09 | |
| LABELING; Labeling | SUPPL | 7 | AP | 1993-12-29 | |
| LABELING; Labeling | SUPPL | 8 | AP | 1993-12-29 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1991-09-09 | |
| LABELING; Labeling | SUPPL | 10 | AP | 1993-12-29 | |
| LABELING; Labeling | SUPPL | 11 | AP | 1995-07-12 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1992-02-18 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1992-02-18 | |
| LABELING; Labeling | SUPPL | 14 | AP | 1993-02-03 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1992-08-31 | |
| LABELING; Labeling | SUPPL | 17 | AP | 1995-07-12 | |
| LABELING; Labeling | SUPPL | 18 | AP | 1996-10-11 | |
| LABELING; Labeling | SUPPL | 19 | AP | 1995-07-12 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 1994-09-02 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 1995-05-09 | |
| LABELING; Labeling | SUPPL | 22 | AP | 1996-10-11 | |
| LABELING; Labeling | SUPPL | 23 | AP | 1997-04-30 | |
| LABELING; Labeling | SUPPL | 24 | AP | 2001-08-31 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 25 | AP | 1996-05-08 | |
| LABELING; Labeling | SUPPL | 26 | AP | 1996-10-11 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 27 | AP | 1996-10-31 | |
| LABELING; Labeling | SUPPL | 28 | AP | 1998-03-17 | |
| LABELING; Labeling | SUPPL | 29 | AP | 1999-01-28 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 30 | AP | 1999-11-29 | |
| LABELING; Labeling | SUPPL | 31 | AP | 2001-08-31 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 32 | AP | 2001-09-10 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 33 | AP | 2001-10-11 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 34 | AP | 2001-10-11 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 35 | AP | 2002-04-19 | |
| LABELING; Labeling | SUPPL | 37 | AP | 2002-08-20 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 38 | AP | 2002-10-17 | |
| LABELING; Labeling | SUPPL | 39 | AP | 2004-04-16 | |
| LABELING; Labeling | SUPPL | 41 | AP | 2004-04-16 | |
| LABELING; Labeling | SUPPL | 45 | AP | 2006-09-19 | |
| LABELING; Labeling | SUPPL | 46 | AP | 2010-04-23 | |
| LABELING; Labeling | SUPPL | 51 | AP | 2012-05-08 | |
| LABELING; Labeling | SUPPL | 53 | AP | 2011-02-28 | |
| LABELING; Labeling | SUPPL | 55 | AP | 2013-06-28 | |
| LABELING; Labeling | SUPPL | 56 | AP | 2017-04-02 | STANDARD |
| LABELING; Labeling | SUPPL | 58 | AP | 2017-03-17 | STANDARD |
Submissions Property Types
| SUPPL | 4 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 13 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 20 | Null | 0 |
| SUPPL | 21 | Null | 0 |
| SUPPL | 25 | Null | 0 |
| SUPPL | 27 | Null | 0 |
| SUPPL | 30 | Null | 0 |
| SUPPL | 32 | Null | 0 |
| SUPPL | 33 | Null | 0 |
| SUPPL | 34 | Null | 0 |
| SUPPL | 35 | Null | 0 |
| SUPPL | 38 | Null | 0 |
| SUPPL | 51 | Null | 15 |
| SUPPL | 55 | Null | 15 |
| SUPPL | 56 | Null | 15 |
| SUPPL | 58 | Null | 31 |
CDER Filings
cder:Array
(
[0] => Array
(
[ApplNo] => 62756
[companyName] =>
[docInserts] => ["",""]
[products] => []
[labels] =>
[originalApprovals] => []
[supplements] =>
[actionDate] => 0000-00-00
)
)