Drug Master Files for: DULOXETINE HYDROCHLORIDE
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DULOXETINE HYDROCHLORIDE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 19631 | A | II | 7/25/2006 | CADILA HEALTHCARE LTD | DULOXETINE HYDROCHLORIDE USP |
| 19860 | I | II | 10/12/2006 | MATRIX LABORATORIES LTD | DULOXETINE HYDROCHLORIDE |
| 19974 | I | II | 11/3/2006 | OLON SPA | DULOXETINE HYDROCHLORIDE |
| 20296 | A | II | 2/26/2007 | DR REDDYS LABORATORIES LTD | DULOXETINE HYDROCHLORIDE |
| 20996 | A | II | 10/30/2007 | MSN LABORATORIES PRIVATE LTD | DULOXETINE HYDROCHLORIDE USP [ROUTE CODE - DX] |
| 21385 | I | II | 2/29/2008 | ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTD | DULOXETINE HYDROCHLORIDE |
| 21478 | A | II | 3/29/2008 | MYLAN LABORATORIES LTD | DULOXETINE HYDROCHLORIDE 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
