Drug Master Files for: pyrilamine maleate
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pyrilamine maleate Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 12901 | I | II | 3/17/1998 | SANDOZ PRIVATE LTD | PYRILAMINE MALEATE USP |
| 26348 | A | II | 5/31/2013 | KESHAVA ORGANICS PVT LTD | PYRILAMINE MALEATE USP |
| 29099 | A | II | 2/21/2015 | SUPRIYA LIFESCIENCE LTD | PYRILAMINE MALEATE USP |
| 366 | I | II | 2/16/1960 | KV PHARMACEUTICAL CO | PYRILAMINE - PHENYLEPHRINE SUSTAINED ACTION CAPSULES |
| 5348 | I | II | 3/14/1984 | HEXAGON LABORATORIES INC | PYRILAMINE MALEATE |
| 6601 | I | II | 9/24/1986 | NOVARTIS PHARMACEUTICALS CORP | PYRILAMINE BASE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
