Drug Master Files for: linezolid
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linezolid Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
14091 | A | II | 4/22/1999 | ALBEMARLE CORP | 1LZD-LINEZOLID, STEP 1 |
19032 | A | II | 12/15/2005 | TEVA PHARMACEUTICAL INDUSTRIES LTD | LINEZOLID |
19746 | A | II | 9/11/2006 | GLENMARK PHARMACEUTICALS LTD | LINEZOLID |
20269 | A | II | 2/15/2007 | SYMED LABS LTD | LINEZOLID (FORM III) |
24506 | A | II | 12/29/2010 | NEULAND LABORATORIES LTD | LINEZOLID USP (FORM-II) |
24790 | A | II | 3/25/2011 | ALEMBIC PHARMACEUTICALS LTD | LINEZOLID |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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