Drug Master Files for: INDAPAMIDE
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INDAPAMIDE Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
21663 | A | II | 5/20/2008 | INDUSTRIALE CHIMICA SRL | INDAPAMIDE |
21975 | A | II | 10/6/2008 | IPCA LABORATORIES LTD | INDAPAMIDE USP |
22388 | I | II | 1/6/2009 | DISHMAN PHARMACEUTICALS AND CHEMICALS LTD | INDAPAMIDE |
8577 | I | II | 5/21/1990 | ORIL INDUSTRIE | INDAPAMIDE |
9026 | A | II | 3/28/1991 | BIOINDUSTRIA LABORATORIO ITALIANO MEDICINALI SPA | INDAPAMIDE |
9064 | A | II | 3/25/1991 | QUIMICA SINTETICA SA | INDAPAMIDE |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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