Drug Master Files for: lisinopril
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lisinopril Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 10853 | I | II | 4/8/1994 | ASTRAZENECA PHARMACEUTICALS LP | LISINOPRIL BULK DRUG |
| 11535 | A | II | 5/26/1995 | FARMHISPANIA SA | LISINOPRIL USP |
| 12912 | I | II | 1/26/1998 | GEDEON RICHTER LTD | LISINOPRIL |
| 12968 | I | II | 4/24/1998 | ESTEVE QUIMICA SA | LISINOPRIL |
| 14536 | I | II | 11/16/1999 | EVONIK CORP | LISINOPRIL CRUDE |
| 14774 | I | II | 3/15/2000 | TEVA PHARMACEUTICAL INDUSTRIES LTD | LISINOPRIL DRUG SUBSTANCE |
| 14801 | A | II | 3/24/2000 | ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD | LISINOPRIL DIHYDRATE, 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
