Drug Master Files for: nifedipine
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nifedipine Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 10280 | I | II | 6/7/1993 | UNIQUE CHEMICALS | NIFEDIPINE |
| 11948 | A | II | 4/24/1996 | EVONIK NUTRITION AND CARE GMBH | NIFEDIPINE |
| 13115 | I | II | 8/7/1998 | CHINA CHEMICAL SYNTHESIS INDUSTRIAL CO LTD | NIFEDIPINE USP, (BULK A PHARMACEUTICAL INGREDIENT), MANFACTURED IN TAIWAN, THE REPUBLIC OF CHINA |
| 15293 | A | II | 2/15/2001 | CATALENT PHARMA SOLUTIONS LLC | NIFEDIPINE (10MG AND 20MG) SOFTGEL CAPSULE |
| 16730 | A | II | 7/29/2003 | UNIQUE CHEMICALS (A DIV OF J B CHEMICALS AND PHARMACEUTICALS LTD) | NIFEDIPINE USP |
| 23117 | A | II | 9/18/2009 | CATALENT PHARMA SOLUTIONS LLC | PROCARDIA SOFTGELS 10 MG (NIFEDIPINE) |
| 25557 | A | II | 12/5/2011 | SHARON BIO MEDICINE LTD | NIFEDIPINE 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
