Drug Master Files for: NICARDIPINE HYDROCHLORIDE
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NICARDIPINE HYDROCHLORIDE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 10104 | A | II | 2/19/1993 | OLON SPA | NICARDIPINE HYDROCHLORIDE |
| 10702 | I | II | 1/25/1994 | MITSUBISHI CORP | NICARDIPINE HYDROCHLORIDE |
| 19552 | A | II | 6/26/2006 | CHEMWERTH INC | NICARDIPINE HYDROCHLORIDE, NON-STERILE, BULK DRUG SUBSTANCE |
| 19773 | A | II | 9/15/2006 | NAVINTA LLC | NICARDIPINE HYDROCHLORIDE |
| 21211 | A | II | 12/31/2007 | WOCKHARDT LTD | NICARDIPINE HYDROCHLORIDE |
| 21625 | A | II | 3/25/2008 | LUSOCHIMICA SPA | NICARDIPINE HYDROCHLORIDE (INTENDED FOR PARENTERAL USE) |
| 22044 | I | II | 9/30/2008 | DR REDDYS LABORATORIES LTD | NICARDIPINE HYDROCHLORIDE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
