Drug Master Files for: ramipril
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ramipril Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
15208 | A | II | 12/19/2000 | SANOFI AVENTIS DEUTSCHLAND GMBH | RAMIPRIL |
16193 | A | II | 10/17/2002 | DR REDDYS LABORATORIES LTD | RAMIPRIL USP |
16647 | A | II | 6/10/2003 | NEULAND LABORATORIES LTD | RAMIPRIL USP |
16900 | I | II | 10/13/2003 | ESTEVE QUIMICA SA | RAMIPRIL |
17033 | A | II | 12/17/2003 | CIPLA LTD | RAMIPRIL USP |
17401 | I | II | 5/20/2004 | SMS PHARMACEUTICALS LTD | RAMIPRIL |
17570 | A | II | 7/16/2004 | AUROBINDO PHARMA LTD | RAMIPRIL 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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