Drug Master Files for: PAROXETINE MESYLATE
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PAROXETINE MESYLATE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 12770 | I | II | 12/3/1997 | APOTEX PHARMACHEM INC | PAROXETINE HYDROCHLORIDE (ANHYDROUS) |
| 13888 | I | II | 12/7/1998 | SUMITOMO CHEMICAL CO LTD | PAROXETINE HYDROCHLORIDE ANHYDRATE |
| 14432 | I | II | 9/30/1999 | ASAHI GLASS CO LTD | PAROXETINE HYDROCHLORIDE AMORPHOUS |
| 14475 | I | II | 10/13/1999 | GLAXOSMITHKLINE | PAROXETINE HYDROCHLORIDE HEMIHYDRATE |
| 14913 | A | II | 6/1/2000 | AESICA PHARMACEUTICALS LTD | PAROXETINE HYDROCHLORIDE |
| 15039 | A | II | 9/15/2000 | GLAXOSMITHKLINE | PAROXETINE HYDROCHLORIDE HEMIHYDRATE |
| 15463 | I | II | 5/29/2001 | CHEMI SPA | PAROXETINE ACETATE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
