Drug Master Files for: timolol maleate
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timolol maleate Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 10690 | A | II | 1/25/1994 | PCAS | TIMOLOL HEMIHYDRATE |
| 10900 | I | II | 5/12/1994 | VIALE FULVIO TESTI | TIMOLOL MALEATE |
| 12234 | I | II | 11/22/1996 | DEGUSSA AG WERK RADEBEUL | TIMOLOL MALEATE |
| 14750 | I | II | 2/29/2000 | SIFAVITOR SPA | TIMOLOL MALEATE |
| 15516 | A | II | 7/4/2001 | EXCELLA GMBH AND CO KG | TIMOLOL MALEATE |
| 15580 | A | II | 8/10/2001 | EXCELLA GMBH AND CO KG | TIMOLOL HEMIHYDRATE |
| 23009 | A | II | 7/31/2009 | SYN-TECH CHEM AND PHARM CO LTD | TIMOLOL MALEATE 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
