Drug Master Files for: indomethacin
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indomethacin Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
21740 | A | II | 6/28/2008 | MACLEODS PHARMACEUTICALS LTD | INDOMETHACIN DRUG SUBSTANCE |
21984 | A | II | 9/16/2008 | CSPC OUYI PHARMACEUTICAL CO LTD | INDOMETHACIN |
22751 | A | II | 4/29/2009 | SOLARA A PHARMA SCIENCES LTD | INDOMETHACIN SODIUM |
25401 | A | II | 10/31/2011 | GLAND PHARMA LTD | INDOMETHACIN SODIUM USP |
2633 | I | II | 3/1/1976 | INDUSTRIE CHIMICHE FARMACEUTICHE ITALIANE SPA | INDOMETHACIN |
26340 | A | II | 4/24/2013 | IROKO PHARMACEUTICALS LLC | TIVORBEX (INDOMETHACIN) CAPSULES |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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