Drug Master Files for: CINACALCET HYDROCHLORIDE
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CINACALCET HYDROCHLORIDE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 21264 | A | II | 1/23/2008 | TEVA PHARMACEUTICAL INDUSTRIES LTD | CINACALCET HYDROCHLORIDE |
| 21405 | A | II | 3/6/2008 | MEDICHEM MANUFACTURING MALTA LTD | CINACALCET HYDROCHLORIDE (MED-200140/M ) |
| 23910 | A | II | 6/23/2010 | ACTAVIS GROUP PTC EHF | CINACALCET HYDROCHLORIDE (NON-STERILE BULK DRUG SUBSTANCE) |
| 24297 | A | II | 10/29/2010 | IND SWIFT LABORATORIES LTD | CINACALCET HYDROCHLORIDE |
| 24881 | A | II | 4/22/2011 | MEGAFINE PHARMA P LTD | CINACALCET HYDROCHLORIDE (NON-STERILE DRUG SUBSTANCE) |
| 25889 | A | II | 3/29/2012 | JUBILANT GENERICS LTD | CINACALCET HYDROCHLORIDE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
