Drug Master Files for: tolvaptan
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tolvaptan Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 27052 | A | II | 4/3/2013 | HETERO DRUGS LTD | TOLVAPTAN |
| 27132 | A | II | 5/22/2013 | ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD | TOLVAPTAN |
| 27636 | A | II | 12/4/2013 | APOTEX PHARMACHEM INDIA PVT LTD | TOLVAPTAN |
| 27808 | A | II | 12/28/2013 | MSN LABORATORIES PRIVATE LTD | TOLVAPTAN (AMORPHOUS) [ROUTE CODE TNA] |
| 27833 | A | II | 1/13/2014 | JIANGSU HENGRUI MEDICINE CO LTD | TOLVAPTAN |
| 28010 | A | II | 2/26/2014 | MSN LABORATORIES PRIVATE LTD | TOLVAPTAN [ROUTE CODE TN] |
| 32030 | A | II | 10/6/2017 | ALKEM LABORATORIES LTD | TOLVAPTAN |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
