Drug Master Files for: Lax
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Lax Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
10055 | I | II | 1/25/1993 | GLAXO WELLCOME INC | MANUFACTURING PRODUCTION FACILITY IN TORONTO, CANADA |
10179 | I | II | 6/8/1989 | GLAXOCHEM LTD | PENICILLIN G INTERMEDIATES |
10661 | I | II | 1/5/1994 | GLAXO WELLCOME INC | MANUFACTURING FACILITY AT VERONA, ITALY. |
10729 | A | V | 2/23/1994 | GLAXOSMITHKLINE LLC | PHARMACOLOGY AND TOXICOLOGY INFORMATION REGARDING PROPELLANT HFA-134A (GR106642X) |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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