Drug Master Files for: DIATRIZOATE MEGLUMINE
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DIATRIZOATE MEGLUMINE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 20924 | A | II | 10/5/2007 | AMRI RENSSELAER INC | DIATRIZOATE SODIUM USP DRUG SUBSTANCE |
| 27165 | A | II | 5/22/2013 | AMRI RENSSELAER INC | DIATRIZOATE MEGLUMINE, USP |
| 28739 | A | II | 11/5/2014 | BIOPHORE INDIA PHARMACEUTICALS PVT LTD | DIATRIZOATE SODIUM |
| 28740 | A | II | 10/31/2014 | BIOPHORE INDIA PHARMACEUTICALS PVT LTD | DIATRIZOATE MEGLUMINE |
| 32736 | A | II | 7/23/2018 | VASUDHA PHARMA CHEM LTD | DIATRIZOATE SODIUM USP |
| 32737 | A | II | 7/25/2018 | VASUDHA PHARMA CHEM LTD | DIATRIZOATE MEGLUMINE USP |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
