Drug Master Files for: ertapenem sodium
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ertapenem sodium Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 27348 | A | II | 9/24/2013 | PFIZER HEALTHCARE INDIA PVT LTD | ERTAPENEM SODIUM |
| 28391 | A | II | 6/16/2014 | SOLARA A PHARMA SCIENCES LTD | ERTAPENEM SODIUM |
| 29102 | A | II | 4/13/2015 | ACS DOBFAR SPA | ERTAPENEM SODIUM |
| 29473 | I | II | 6/12/2015 | ASYMCHEM LABORATORIES FUXIN CO LTD | ERTAPENEM SODIUM |
| 30123 | A | II | 1/7/2016 | SUN PHARMACEUTICAL INDUSTRIES LTD | ERTAPENEM SODIUM |
| 30311 | A | II | 3/7/2016 | AUROBINDO PHARMA LTD | ERTAPENEM SODIUM |
| 30709 | A | II | 5/19/2016 | QILU ANTIBIOTICS LINYI PHARMACEUTICAL CO LTD | ERTAPENEM SODIUM (NON-STERILE) |
| >DMF No. | >Status | >Type | >Submission Date | >Holder | >Subject |
Drug Master File Glossary
STATUS OF DMFS
- A = Active. This means that the DMF was found acceptable for filing, administratively, and is up-to-date.
- I = Inactive
- N = Not an assigned number
- P = DMF Pending Filing Review
TYPES OF DMFs
- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)
- Type II Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product
- Type III Packaging Material
- Type IV Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation
- Type V FDA Accepted Reference Information
