Drug Master Files for: DAPSONE
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DAPSONE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 15065 | A | II | 9/29/2000 | LUNDBECK PHARMACEUTICALS ITALY SPA | DAPSONE |
| 17781 | A | II | 10/28/2004 | ATUL LTD | DAPSONE USP |
| 25089 | I | II | 6/29/2011 | REGIS TECHNOLOGIES INC | DAPSONE, USP |
| 27678 | A | II | 12/13/2013 | NOVITIUM PHARMA LLC | DAPSONE USP |
| 27701 | A | II | 11/6/2013 | SAI LIFE SCIENCES LTD | DAPSONE USP |
| 29999 | A | II | 3/31/2016 | TARO PHARMACEUTICAL INDUSTRIES LTD | DAPSONE USP |
| 31521 | A | II | 6/22/2017 | DIPHARMA FRANCIS SRL | DAPSONE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
