Drug Master Files for: RABEPRAZOLE SODIUM
✉ Email this page to a colleague
RABEPRAZOLE SODIUM Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 16747 | A | II | 8/4/2003 | DR REDDYS LABORATORIES LTD | RABEPRAZOLE SODIUM HYDRATE (FORM Y) USP |
| 16764 | I | II | 8/18/2003 | CIPLA LTD | RABEPRAZOLE SODIUM |
| 18226 | I | II | 3/31/2005 | CADILA HEALTHCARE LTD | RABEPRAZOLE SODIUM |
| 19186 | A | II | 1/31/2006 | AUROBINDO PHARMA LTD | RABEPRAZOLE SODIUM |
| 19903 | A | II | 10/25/2006 | LUPIN LTD | RABEPRAZOLE SODIUM |
| 20818 | I | II | 8/29/2007 | AMINO CHEMICALS LTD | RABEPRAZOLE SODIUM MONOHYDRATE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
