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? |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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