Drug Master Files for: nisoldipine
✉ Email this page to a colleague
nisoldipine Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 10167 | A | II | 3/31/1993 | BAYER AG | NISOLDIPINE |
| 14337 | A | II | 7/28/1999 | LUSOCHIMICA SPA | NISOLDIPINE |
| 16215 | A | II | 10/22/2002 | ERREGIERRE SPA | NISOLDIPINE |
| 19329 | I | II | 4/4/2006 | SANMAR SPECIALITY CHEMICALS LTD | NISOLDIPINE, NON-STERILE BULK DRUG SUBSTANCE |
| 21106 | A | II | 11/3/2007 | PAR A TECHNOLOGIES PRIVATE LTD | NISOLDIPINE NON STERILE BULK DRUG SUBSTANCE |
| 22539 | A | II | 3/26/2009 | ORCHID PHARMA LTD | NISOLDIPINE (NON-STERILE BULK API) |
| 25365 | A | II | 10/7/2011 | ALEMBIC PHARMACEUTICALS LTD | NISOLDIPINE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
