Documents
Application Sponsors
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
Application Products
| 001 | POWDER;INTRAMUSCULAR | EQ 500MG BASE/VIAL;500MG/VIAL | 0 | PRIMAXIN | CILASTATIN SODIUM; IMIPENEM |
| 002 | POWDER;INTRAMUSCULAR | EQ 750MG BASE/VIAL;750MG/VIAL | 0 | PRIMAXIN | CILASTATIN SODIUM; IMIPENEM |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 1990-12-14 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 1993-11-04 | |
| LABELING; Labeling | SUPPL | 5 | AP | 1993-11-04 | |
| LABELING; Labeling | SUPPL | 6 | AP | 1992-11-23 | |
| LABELING; Labeling | SUPPL | 7 | AP | 1992-11-23 | |
| LABELING; Labeling | SUPPL | 8 | AP | 1994-06-24 | |
| LABELING; Labeling | SUPPL | 9 | AP | 1996-10-02 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1994-09-27 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 1997-01-09 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1995-04-27 | STANDARD |
| LABELING; Labeling | SUPPL | 14 | AP | 1997-06-30 | STANDARD |
| LABELING; Labeling | SUPPL | 15 | AP | 1999-02-04 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 2000-04-10 | STANDARD |
| LABELING; Labeling | SUPPL | 17 | AP | 2001-11-30 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 2001-08-29 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 2002-05-28 | STANDARD |
| LABELING; Labeling | SUPPL | 21 | AP | 2003-03-04 | STANDARD |
| LABELING; Labeling | SUPPL | 23 | AP | 2004-05-20 | STANDARD |
| LABELING; Labeling | SUPPL | 26 | AP | 2006-08-04 | STANDARD |
| LABELING; Labeling | SUPPL | 27 | AP | 2007-03-22 | STANDARD |
| LABELING; Labeling | SUPPL | 28 | AP | 2008-03-28 | STANDARD |
| LABELING; Labeling | SUPPL | 33 | AP | 2008-05-08 | STANDARD |
| LABELING; Labeling | SUPPL | 35 | AP | 2009-08-26 | UNKNOWN |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 16 | Null | 0 |
| SUPPL | 18 | Null | 0 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 23 | Null | 9 |
| SUPPL | 35 | Null | 7 |
CDER Filings
MERCK
cder:Array
(
[0] => Array
(
[ApplNo] => 50630
[companyName] => MERCK
[docInserts] => ["",""]
[products] => [{"drugName":"PRIMAXIN","activeIngredients":"CILASTATIN SODIUM; IMIPENEM","strength":"EQ 500MG BASE\/VIAL;500MG\/VIAL","dosageForm":"POWDER;INTRAMUSCULAR","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"PRIMAXIN","activeIngredients":"CILASTATIN SODIUM; IMIPENEM","strength":"EQ 750MG BASE\/VIAL;750MG\/VIAL","dosageForm":"POWDER;INTRAMUSCULAR","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"08\/26\/2009","submission":"SUPPL-35","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/050587s072,050630s035lbl.pdf\"}]","notes":""},{"actionDate":"03\/28\/2008","submission":"SUPPL-28","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/050587s065,050630s028lbl.pdf\"}]","notes":""},{"actionDate":"03\/22\/2007","submission":"SUPPL-27","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/050630s027lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"PRIMAXIN","submission":"CILASTATIN SODIUM; IMIPENEM","actionType":"EQ 500MG BASE\/VIAL;500MG\/VIAL","submissionClassification":"POWDER;INTRAMUSCULAR","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"PRIMAXIN","submission":"CILASTATIN SODIUM; IMIPENEM","actionType":"EQ 750MG BASE\/VIAL;750MG\/VIAL","submissionClassification":"POWDER;INTRAMUSCULAR","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 2009-08-26
)
)