Drug Master Files for: OXYBUTYNIN
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OXYBUTYNIN Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
11478 | I | II | 4/27/1995 | SELOC AG | OXYBUTYNIN BASE |
11947 | A | II | 4/26/1996 | SIEGFRIED EVIONNAZ SA | OXYBUTYNIN BASE |
12309 | A | II | 1/9/1997 | CORDEN PHARMA CHENOVE | OXYBUTYNIN HYDROCHLORIDE |
12840 | I | II | 2/2/1998 | SANOFI AVENTIS SPA | OXYBUTYNIN CHLORIDE |
13084 | A | II | 7/22/1998 | PCAS | OXYBUTYNIN BASE |
14071 | I | II | 3/30/1999 | JUZEN CHEMICAL CORP | OXYBUTYNIN |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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