Drug Master Files for: candesartan cilexetil
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candesartan cilexetil Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 18828 | A | II | 10/3/2005 | CADILA HEALTHCARE LTD | CANDESARTAN CILEXETIL USP |
| 19990 | A | II | 11/22/2006 | DR REDDYS LABORATORIES LTD | CANDESARTAN CILEXETIL USP |
| 20053 | I | II | 12/18/2006 | LEK PHARMACEUTICALS DD | CANDESARTAN CILEXETIL |
| 20091 | I | II | 12/27/2006 | RANBAXY LABORATORIES LTD | CANDESARTAN CILEXETIL (NON STERILE BULK) DRUG SUBSTANCE |
| 20400 | A | II | 4/2/2007 | MYLAN LABORATORIES LTD | CANDESARTAN CILEXETIL 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
