Drug Master Files for: METHOCARBAMOL
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METHOCARBAMOL Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
10410 | A | II | 8/13/1993 | SYNTHOKEM LABS PRIVATE LTD | METHOCARBAMOL USP |
10833 | I | II | 3/25/1994 | SIANG TA PHARMACEUTICAL CO LTD | METHOCARBAMOL |
13080 | A | II | 7/17/1998 | CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTD | METHOCARBAMOL USP |
14012 | I | II | 3/1/1999 | LABORATORIES ARGENOI SL | METHOCARBAMOL, MAUFACTURED IN ZARAGOZA, SPAIN |
14906 | I | II | 5/31/2000 | BIDACHEM SPA | METHOCARBAMOL |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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