Drug Master Files for: SCOPOLAMINE
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SCOPOLAMINE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 11679 | I | II | 9/20/1995 | BOEHRINGER INGELHEIM PHARMA KG | SCOPOLAMINE-N-BUTLYBROMIDE (BUSCOPAN) |
| 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 |
| 19774 | I | II | 9/14/2006 | BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG | SCOPOLAMINE (HYOSCINE) |
| 24477 | A | II | 10/1/2010 | VITAL LABORATORIES PVT LTD | SCOPOLAMINE BUTYL BROMIDE (HYOSCINE BUTYL 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
