Drug Master Files for: DOXEPIN HYDROCHLORIDE
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DOXEPIN HYDROCHLORIDE Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
2410 | I | II | 2/25/1975 | BOEHRINGER MANNHEIM GMBH | DOXEPIN |
3230 | A | II | 5/26/1978 | TEVA PHARMACEUTICAL INDUSTRIES LTD | DOXEPIN HCL USP |
4494 | I | II | 3/10/1982 | SMITH KLINE & FRENCH LABS DIV SMITHKLINE BECKMAN CORP | DOXEPIN HCL |
5025 | A | II | 7/21/1983 | OLON SPA | DOXEPINE HYDROCHLORIDE |
5076 | I | II | 5/24/1983 | SUMIKA FINE CHEMICALS CO LTD | DOXEPIN USP XX |
5404 | A | II | 4/10/1984 | DIPHARMA FRANCIS SRL | DOXEPIN HCl |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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