Drug Master Files for: ISOETHARINE HYDROCHLORIDE
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ISOETHARINE HYDROCHLORIDE Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
11089 | I | II | 9/16/1994 | SANOFI SYNTHELABO INC | ISOETHARINE MESYLATE AND ISOETHARINE HYDROCHLORIDE |
12116 | I | II | 9/3/1996 | BI CHEMICALS INC | ISOETHARINE HYDROCHLORIDE |
1938 | I | II | 5/17/1972 | MINN 3M LABS LTD | ISOETHARINE SALTS INCLUDING ISOETHARINE MESYLATE |
1984 | I | II | 8/11/1972 | MINN 3M LABS LTD | ISOETHARINE HCl USP & NUMOTAC TABLETS WITH ISOETHARINE 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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