Drug Master Files for: bimatoprost
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bimatoprost Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
20911 | A | II | 10/4/2007 | JOHNSON MATTHEY PHARMA SERVICES | BIMATOPROST (3077.E) |
21382 | A | II | 2/26/2008 | CHIROGATE INTERNATIONAL INC | BIMATOPROST |
21681 | A | II | 6/10/2008 | KYOWA PHARMA CHEMICAL CO LTD | BIMATOPROST DRUG SUBSTANCE |
22080 | A | II | 10/14/2008 | EVERLIGHT CHEMICAL INDUSTRIAL CORP | BIMATOPROST |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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