Drug Master Files for: Smith And Nephew
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Smith And Nephew Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
8212 | I | II | 9/19/1989 | SMITH AND NEPHEW RES LTD | APRACLONIDINE HCl |
8213 | I | I | 9/19/1989 | SMITH AND NEPHEW RES LTD | MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN HARLOW, ESSEX, UNITED KINGDOM. |
8214 | I | II | 9/19/1989 | SMITH AND NEPHEW PHARMACEUTICALS LTD | MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN ROORD, ESSEX, UNITED KINGDOM |
8662 | I | II | 7/19/1990 | SMITH AND NEPHEW RES LTD | BETAXOLOL HCL (NODS) |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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