Drug Master Files for: tropicamide
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tropicamide Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 10981 | A | II | 7/8/1994 | TOKYO CHEMICAL INDUSTRY CO LTD | TROPICAMIDE USP |
| 12596 | I | II | 7/18/1997 | CARBOGEN AMCIS AG | TROPICAMIDE |
| 14743 | I | II | 2/15/2000 | OKAMI CHEMICAL INDUSTRY CO LTD | TROPICAMIDE |
| 14940 | I | II | 7/3/2000 | SHIONO FINESSE LTD | TROPICAMIDE |
| 17800 | A | II | 10/15/2004 | UQUIFA MEXICO SA DE CV | TROPICAMIDE |
| 5257 | I | II | 5/11/1983 | SANTEN PHARMACEUTICAL CO LTD | TROPICAMIDE MYDRIATIC |
| 6006 | I | II | 9/9/1985 | AMCIS AG | TROPICAMIDE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
