DrugPatentWatch Database Preview
Drug Master Files for: Emd Serono
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Emd Serono Drug Master Files
||EMD SERONO INC
||BIOEQUIVALANCE STUDY ON THREE CLOMIPHENE CITRATE PRODUCTS
||EMD SERONO INC
||MURINE MONOCLONAL ANTI-FSH ANTIBODY 9/14
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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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
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