Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | POWDER;INTRAVENOUS | EQ 250MG BASE/VIAL;250MG/VIAL | 0 | IMIPENEM AND CILASTATIN | CILASTATIN SODIUM; IMIPENEM |
| 002 | POWDER;INTRAVENOUS | EQ 500MG BASE/VIAL;500MG/VIAL | 0 | IMIPENEM AND CILASTATIN | CILASTATIN SODIUM; IMIPENEM |
FDA Submissions
| ORIG | 1 | AP | 2011-12-21 | |
| LABELING; Labeling | SUPPL | 3 | AP | 2015-05-29 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2015-05-29 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2019-07-09 | STANDARD |
| LABELING; Labeling | SUPPL | 12 | AP | 2019-07-09 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| SUPPL | 3 | Null | 8 |
| SUPPL | 6 | Null | 7 |
| SUPPL | 10 | Null | 7 |
| SUPPL | 12 | Null | 7 |
TE Codes
CDER Filings
ACS DOBFAR
cder:Array
(
[0] => Array
(
[ApplNo] => 90577
[companyName] => ACS DOBFAR
[docInserts] => ["",""]
[products] => [{"drugName":"IMIPENEM AND CILASTATIN","activeIngredients":"CILASTATIN SODIUM; IMIPENEM","strength":"EQ 250MG BASE\/VIAL;250MG\/VIAL","dosageForm":"POWDER;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"Yes"},{"drugName":"IMIPENEM AND CILASTATIN","activeIngredients":"CILASTATIN SODIUM; IMIPENEM","strength":"EQ 500MG BASE\/VIAL;500MG\/VIAL","dosageForm":"POWDER;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"IMIPENEM AND CILASTATIN","submission":"CILASTATIN SODIUM; IMIPENEM","actionType":"EQ 250MG BASE\/VIAL;250MG\/VIAL","submissionClassification":"POWDER;INTRAVENOUS","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"IMIPENEM AND CILASTATIN","submission":"CILASTATIN SODIUM; IMIPENEM","actionType":"EQ 500MG BASE\/VIAL;500MG\/VIAL","submissionClassification":"POWDER;INTRAVENOUS","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)