Drug Master Files for: ETODOLAC
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ETODOLAC Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 11359 | A | II | 2/20/1995 | AMSA SPA | ETODOLAC |
| 11405 | A | II | 3/29/1995 | ZAKLADY FARMACEUTYCZNE POLPHARMA SA | ETODOLAC |
| 11740 | I | II | 11/6/1995 | CHEMI SPA | ETODOLAC |
| 11766 | A | II | 12/11/1995 | TEVA PHARMACEUTICAL INDUSTRIES LTD | ETODOLAC |
| 12618 | I | II | 8/8/1997 | RANBAXY PHARMACEUTICALS INC | ETODOLAC DRUG SUBSTANCE |
| 14298 | I | II | 7/16/1999 | CHEMSOURCE CORP | ETODOLAC DRUG SUBSTANCE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
