Drug Master Files for: NIMODIPINE
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NIMODIPINE Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
14979 | A | II | 7/26/2000 | LUSOCHIMICA SPA | NIMODIPINE |
15598 | I | II | 8/27/2001 | CATALENT PHARMA SOLUTIONS LLC | NIMODIPINE 30MG SOFTGEL CAPSULES |
16951 | A | II | 11/3/2003 | UNION QUIMICO FARMACEUTICA SA (UQUIFA SA) | NIMODIPINE (MICRONIZED) |
17849 | I | II | 11/22/2004 | USV LTD | NIMODIPINE USP |
18373 | I | II | 5/24/2005 | CATALENT PHARMA SOLUTIONS LLC | NIMODIPINE 30MG SOFTGELS |
32971 | A | II | 10/1/2018 | DASAMI LAB PRIVATE LTD | NIMODIPINE |
4664 | I | II | 9/8/1982 | BAYER HEALTHCARE AG | NIMODIPINE |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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