Drug Master Files for: etomidate
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etomidate Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
10635 | I | II | 12/17/1993 | JANSSEN PHARMACEUTICA NV | ETOMIDATE |
11229 | A | II | 11/15/1994 | RELIABLE BIOPHARMACEUTICAL LLC | ETOMIDATE |
15983 | A | II | 5/24/2002 | PISGAH LABS INC | ETOMIDATE |
20234 | A | II | 1/29/2007 | BACHEM SA | ETOMIDATE |
20500 | A | II | 4/30/2007 | CHEMWERTH INC | ETOMIDATE USP NON STERILE BULK DRUG SUBSTANCE |
27580 | A | II | 9/20/2013 | SOLARA A PHARMA SCIENCES LTD | ETOMIDATE |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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