Drug Master Files for: thiamine hydrochloride
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thiamine hydrochloride Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
24777 | I | II | 3/19/2011 | EMCURE PHARMACEUTICALS LTD | THIAMINE HYDROCHLORIDE USP |
27482 | A | II | 9/29/2013 | BIOPHORE INDIA PHARMACEUTICALS PVT LTD | THIAMINE HYDROCHLORIDE |
29461 | A | II | 6/18/2015 | JIANGXI TIANXIN PHARMACEUTICAL CO LTD | THIAMINE HYDROCHLORIDE |
30634 | A | II | 6/29/2016 | DSM NUTRITIONAL PRODUCTS LTD | THIAMINE HYDROCHLORIDE |
32731 | A | II | 3/28/2018 | JIANGSU BROTHER VITAMINS CO LTD | THIAMINE MONONITRATE |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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