Drug Master Files for: tolbutamide
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tolbutamide Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
10388 | I | II | 7/30/1993 | PHARMACEUTICAL WORKS POLPHARMA SA | TOLBUTAMIDE |
25168 | A | II | 7/1/2011 | KOTHARI PHYTOCHEMICALS INTERNATIONAL | TOLBUTAMIDE USP |
2840 | I | II | 2/4/1977 | DELMAR CHEMICALS INC | TOLBUTAMIDE (COARSE) |
2841 | I | II | 2/4/1977 | DELMAR CHEMICALS INC | TOLBUTAMIDE (FINE) |
3139 | A | II | 2/28/1978 | DIPHARMA FRANCIS SRL | TOLBUTAMIDE 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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