Drug Master Files for: LANSOPRAZOLE
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LANSOPRAZOLE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 11762 | I | III | 11/27/1995 | PROMEXMEDICAL INC | SECONDARY PACKAGING OF PREVACID 15MG & 30MG CAPSULES OF LANSOPRAZOLE, MEDISCRIPTS STARTER |
| 17014 | I | II | 12/9/2003 | DR REDDYS LABORATORIES LTD | LANSOPRAZOLE FORM-1 |
| 17551 | A | II | 7/20/2004 | TEVA PHARMACEUTICAL INDUSTRIES LTD | LANSOPRAZOLE |
| 17787 | A | II | 10/28/2004 | UNION QUIMICO FARMACEUTICA SA (UQUIFA SA) | LANSOPRAZOLE |
| 17819 | A | II | 11/2/2004 | MOEHS IBERICA SL | LANSOPRAZOLE |
| 18205 | I | II | 3/22/2005 | ITF CHEMICAL LTDA | LANSOPRAZOLE |
| 18251 | A | II | 3/29/2005 | LUPIN LTD | LANSOPRAZOLE 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
