Drug Master Files for: DINOPROST TROMETHAMINE
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DINOPROST TROMETHAMINE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 10621 | I | II | 12/15/1993 | CAYMAN PHARMA SRO | PROSTAGLANDIN E2 (DINOPROSTONE) |
| 11274 | A | II | 12/27/1994 | KYOWA PHARMA CHEMICAL CO LTD | DINOPROSTONE DRUG SUBSTANCE |
| 11563 | A | II | 7/6/1995 | CHINOIN PHARMACEUTICAL AND CHEMICAL WORKS PRIVATE CO LTD | DINOPROSTONE (PROSTAGLANDIN E2) |
| 23248 | I | II | 11/9/2009 | CHINOIN PHARMACEUTICAL AND CHEMICAL WORKS PRIVATE CO LTD | DINOPROST |
| 5202 | A | II | 1/3/1984 | PHARMACIA AND UPJOHN CO LLC WHOLLY OWNED SUB OF PFIZER INC | DINOPROSTONE USP |
| 5319 | A | II | 4/6/1984 | PHARMACIA AND UPJOHN CO LLC WHOLLY OWNED SUB OF PFIZER INC | DINOPROST TROMETHAMINE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
