Drug Master Files for: silodosin
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silodosin Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
13030 | A | II | 6/18/1998 | KISSEI PHARMACEUTICALS CO LTD | KMD-3213 (SILODOSIN) DRUG SUBSTANCE |
26251 | A | II | 9/10/2012 | CADILA HEALTHCARE LTD | SILODOSIN |
26423 | A | II | 9/14/2012 | HETERO DRUGS LTD | SILODOSIN |
26459 | A | II | 9/21/2012 | SANDOZ PRIVATE LTD | SILODOSIN |
26957 | A | II | 4/6/2013 | MSN LABORATORIES PRIVATE LTD | SILODOSIN [ROUTE CODE - SD] |
27082 | A | II | 4/20/2013 | ALP PHARM BEIJING CO LTD | SILODOSIN |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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