Drug Master Files for: DEXLANSOPRAZOLE
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DEXLANSOPRAZOLE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 22607 | A | II | 3/12/2009 | DR REDDYS LABORATORIES LTD | DEXLANSOPRAZOLE (AMORPHOUS) |
| 23380 | A | II | 12/16/2009 | DIPHARMA FRANCIS SRL | DEXLANSOPRAZOLE |
| 23655 | A | II | 3/22/2010 | DR REDDYS LABORATORIES LTD | DEXLANSOPRAZOLE (CRYSTALLINE) |
| 23722 | A | II | 4/19/2010 | MSN LABORATORIES PRIVATE LTD | DEXLANSOPRAZOLE ANHYDROUS [ROUTE CODE - DZ] |
| 24503 | A | II | 12/21/2010 | MYLAN LABORATORIES LTD | DEXLANSOPRAZOLE SESQUIHYDRATE |
| 24815 | A | II | 4/1/2011 | MSN LABORATORIES PRIVATE LTD | DEXLANSOPRAZOLE SESQUIHYDRATE [ROUTE CODE - DP] |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
