Drug Master Files for: mestranol
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mestranol Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 1174 | I | II | 4/24/1968 | PHYTOGEN PRODUCTS INC | IDENTIFICATION, ASSAY & SPECIFICATION FOR MESTRANOL |
| 1614 | I | II | 11/18/1970 | ROUSSEL CORP | MESTRANOL |
| 17066 | I | II | 12/31/2003 | SCINOPHARM TAIWAN LTD | MESTRANOL USP |
| 1988 | I | II | 8/28/1972 | SEARLE | NORTHINDQONE, MESTRANOL, MEDROXYPROGESTERONE |
| 22383 | I | III | 12/24/2008 | SHANDONG PHARMACEUTICAL GLASS CO LTD | MESTRANOL 3-METHOXY-17-ETHINYL-ES POLYISOPRENE RUBBEER CAPS FOR NEEDLES FOR PREFILLED SYRINGES |
| 3951 | I | II | 9/22/1980 | NV ORGANON | MESTRANOL |
| 417 | I | II | 12/28/1960 | WATSON LABORATORIES INC | MESTRANOL 3-METHOXY-172-ETHINYL-ESTRADIOL- MANUF PROCEDURES |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
