Drug Master Files for: GLAXOSMITHKLINE
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GLAXOSMITHKLINE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 10729 | A | V | 2/23/1994 | GLAXOSMITHKLINE LLC | PHARMACOLOGY AND TOXICOLOGY INFORMATION REGARDING PROPELLANT HFA-134A (GR106642X) |
| 13207 | A | II | 4/30/1998 | GLAXOSMITHKLINE LLC | AMOXICILLIN TRIHYDRATE |
| 13338 | I | II | 9/1/1998 | GLAXOSMITHKLINE LLC | GRISEOFULVIN |
| 13961 | I | II | 1/29/1999 | GLAXOSMITHKLINE LLC | MUPIROCIN FREE ACID AND MUPIROCIN CALCIUM (NON-STERILE) |
| 14475 | I | II | 10/13/1999 | GLAXOSMITHKLINE | PAROXETINE HYDROCHLORIDE HEMIHYDRATE |
| 15039 | A | II | 9/15/2000 | GLAXOSMITHKLINE | PAROXETINE HYDROCHLORIDE HEMIHYDRATE |
| 15257 | I | II | 1/19/2001 | GLAXO GROUP LTD DBA GLAXOSMITHKLINE | FONDAPARINUX SODIUM |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
