Drug Master Files for: perindopril erbumine
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perindopril erbumine Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
17713 | A | II | 9/30/2004 | GLENMARK PHARMACEUTICALS LTD | PERINDOPRIL ERBUMINE |
17958 | A | II | 12/29/2004 | LUPIN LTD | PERINDOPRIL TERT-BUTYLAMINE |
18865 | A | II | 10/14/2005 | MYLAN LABORATORIES LTD | PERINDOPRIL TERT-BUTYLAMINE |
19095 | A | II | 1/6/2006 | HETERO DRUGS LTD | PERINDOPRIL TERT-BUTYLAMINE |
19484 | A | II | 5/31/2006 | AUROBINDO PHARMA LTD | PERINDOPRIL TERT-BUTYLAMINE DRUG SUBSTANCE |
20165 | A | II | 9/6/2007 | CIPLA LTD | PERINDOPRIL ERBUMINE MONOHYDRATE |
20788 | I | II | 8/21/2007 | BACHEM SA | PERINDOPRIL TERT-BUTYLAMINE |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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