Drug Master Files for: testosterone undecanoate
✉ Email this page to a colleague
testosterone undecanoate Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 11826 | A | II | 1/3/1996 | ASPEN OSS BV | TESTOSTERONE |
| 14540 | A | II | 11/18/1999 | ASPEN OSS BV | TESTOSTERONE UNDECANOATE |
| 15077 | A | II | 10/2/2000 | BAYER AG | TESTOSTERONE |
| 16136 | I | II | 9/16/2002 | 3M PHARMACEUTICALS SBC | TESTOSTERONE/ESTRADIOL TRANSDERMAL DELIVERY SYSTEMS CHEMISTRY, MANUFACTURING, AND CONTROLS (CMC) AND TOXICOLOGY |
| 16795 | A | II | 8/15/2003 | BAYER AG | TESTOSTERONE UNDECANOATE |
| 16809 | A | II | 8/15/2003 | BAYER AG | TESTOSTERONE UNDECANOATE 750 MG I.M. |
| 18804 | I | II | 9/19/2005 | HENAN QUANXIN MEDICAL CHEMICAL TECHNOLOGY CO LTD | METHYLTESTOSTERONE 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
