Drug Master Files for: LOPERAMIDE HYDROCHLORIDE
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LOPERAMIDE HYDROCHLORIDE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 10028 | A | II | 12/30/1992 | OLON SPA | LOPERAMIDE HYDROCHLORIDE |
| 10517 | A | II | 9/30/1993 | OLON SPA | LOPERAMIDE HYDROCHLORIDE |
| 10942 | I | II | 6/17/1994 | JANSSEN PHARMACEUTICA NV | LOPERAMIDE HYDROCHLORIDE |
| 27731 | A | II | 12/6/2013 | VASUDHA PHARMA CHEM LTD | LOPERAMIDE HYDROCHLORIDE USP |
| 30201 | A | II | 4/28/2016 | ADARE PHARMACEUTICALS INC | LOPERAMIDE MICROCAPS? |
| 7299 | I | II | 1/25/1988 | SIFAVITOR SPA | LOPERAMIDE HYDROCHLORIDE |
| 7340 | A | II | 2/17/1988 | TEVA PHARMACEUTICAL INDUSTRIES LTD | LOPERAMIDE HYDROCHLORIDE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
