Drug Master Files for: guanabenz acetate
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guanabenz acetate Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 5739 | I | II | 3/13/1985 | EVONIK TECHNOCHEMIE GMBH | GUANABENZ ACETATE |
| 5897 | I | II | 6/10/1985 | HELSINN CHEMICALS SA | GUANABENZ ACETATE |
| 7842 | I | II | 12/19/1988 | PROSINTEX INDUSTRIE CHIMIQUE ITALIANE SRL | GUANABENZ ACETATE |
| 7957 | I | II | 3/7/1989 | CILAG CHEMIE AG | GUANABENZ ACETATE |
| 8187 | I | II | 8/9/1989 | FINE CHEMICALS CORP | GUANABENZ ACETATE |
| 8291 | I | II | 11/24/1989 | MEDICHEM SA | GUANABENZ ACETATE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
