Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050630
Company: MERCK
Company: MERCK
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PRIMAXIN | CILASTATIN SODIUM; IMIPENEM | EQ 500MG BASE/VIAL;500MG/VIAL | POWDER;INTRAMUSCULAR | Discontinued | None | No | No |
| PRIMAXIN | CILASTATIN SODIUM; IMIPENEM | EQ 750MG BASE/VIAL;750MG/VIAL | POWDER;INTRAMUSCULAR | Discontinued | None | No | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/26/2009 | SUPPL-35 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050587s072,050630s035lbl.pdf | |
| 03/28/2008 | SUPPL-28 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050587s065,050630s028lbl.pdf | |
| 03/22/2007 | SUPPL-27 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050630s027lbl.pdf |