Drug Master Files for: CHLORTHALIDONE
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CHLORTHALIDONE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 17808 | A | II | 11/3/2004 | IPCA LABORATORIES LTD | CHLORTHALIDONE USP |
| 2438 | A | II | 4/21/1975 | PRIME EUROPEAN THERAPEUTICALS SPA (EUTICALS SPA) | CHLORTHALIDONE USP-EP |
| 26648 | I | II | 11/29/2012 | AMOLI ORGANICS PVT LTD | CHLORTHALIDONE USP |
| 27579 | A | II | 9/30/2013 | IPCA LABORATORIES LTD | CHLORTHALIDONE USP (CT6 PROCESS) |
| 2814 | I | II | 12/15/1976 | INDUSTRIE CHIMICHE FARMACEUTICHE ITALIANE SPA | CHLORTHALIDONE |
| 30551 | A | II | 5/24/2016 | AMOLI ORGANICS PVT LTD | CHLORTHALIDONE USP |
| 32037 | A | II | 9/21/2017 | UNICHEM LABORATORIES LTD | CHLORTHALIDONE 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
