Drug Master Files for: betamethasone sodium phosphate
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betamethasone sodium phosphate Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
10423 | I | II | 8/11/1993 | HOECHST MARION ROUSSEL SA | BETAMETHASONE SODIUM PHOSPHATE |
12749 | A | II | 11/18/1997 | FARMABIOS SPA | BETAMETHASONE VALERATE |
12937 | A | II | 4/3/1998 | MSD INTERNATIONAL GMBH (SINGAPORE BRANCH) | BETAMETHASONE, USP |
14651 | A | II | 12/30/1999 | TARO PHARMACEUTICAL INDUSTRIES LTD | BETAMETHASONE DIPROPIONATE USP, MICRONIZED |
15004 | A | II | 8/18/2000 | TARO PHARMACEUTICAL INDUSTRIES LTD | BETAMETHASONE 17-VALERATE, USP MICRONIZED |
15327 | A | II | 3/1/2001 | TEVA PHARMACEUTICAL INDUSTRIES LTD | BETAMETHASONE ACETATE |
17016 | A | II | 11/26/2003 | TIANJIN TIANYAO PHARMACEUTICALS CO LTD | BETAMETHASONE USP |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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