Drug Master Files for: Mylan Technologies
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Mylan Technologies Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
10429 | A | III | 8/18/1993 | MYLAN TECHNOLOGIES INC | 2226 LINER |
11396 | I | III | 1/16/1995 | MYLAN TECHNOLOGIES INC | 2229 PEELABLE RELEASE LINER |
11404 | A | III | 3/15/1995 | MYLAN TECHNOLOGIES INC | MEDIFLEXr 1200 and MEDIFLEXr 1501 |
11884 | I | IV | 3/4/1996 | MYLAN TECHNOLOGIES INC | BERTEK CODE 44119 MEDILAM 3600 |
12051 | I | III | 7/19/1996 | MYLAN TECHNOLOGIES INC | MEDIDERM 3800 |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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