Drug Master Files for: Concord Biotech Ltd
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Concord Biotech Ltd Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
17393 | A | II | 5/17/2004 | CONCORD BIOTECH LTD | LOVASTATIN USP |
18908 | A | II | 10/24/2005 | CONCORD BIOTECH LTD | TACROLIMUS USP |
19044 | I | II | 12/13/2005 | CONCORD BIOTECH LTD | SIMVASTATIN USP |
19231 | A | II | 3/7/2006 | CONCORD BIOTECH LTD | MYCOPHENOLATE MOFETIL USP |
20727 | A | II | 8/16/2007 | CONCORD BIOTECH LTD | PRAVASTATIN SODIUM USP |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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