Drug Master Files for: METHSCOPOLAMINE BROMIDE
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METHSCOPOLAMINE BROMIDE Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
18069 | I | II | 2/8/2005 | BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG | METHSCOPOLAMINE BROMIDE |
1809 | I | 9/30/1971 | CENTERCHEM INC | METHSCOPOLAMINE BROMIDE, N.F. XIII | |
18294 | I | II | 4/20/2005 | BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG | METHSCOPOLAMINE NITRATE |
28629 | A | II | 9/8/2014 | ALKALOIDS CORP | METHSCOPOLAMINE BROMIDE |
29805 | A | II | 9/24/2015 | ALCHEM INTERNATIONAL LTD | METHSCOPOLAMINE BROMIDE USP |
30962 | A | II | 9/10/2016 | VITAL LABORATORIES PVT LTD | METHSCOPOLAMINE BROMIDE |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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