Drug Master Files for: PARICALCITOL
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PARICALCITOL Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 16402 | A | II | 2/3/2003 | CATALENT PHARMA SOLUTIONS LLC | ZEMPLAR (PARICALCITOL) 2 & 4 MCG CAPSULES |
| 20865 | A | II | 9/19/2007 | TEVA PHARMACEUTICAL INDUSTRIES LTD | PARICALCITOL USP |
| 21255 | A | II | 1/16/2008 | ALP PHARM BEIJING CO LTD | PARICALCITOL USP (NON-STERILE DRUG SUBSTANCE) |
| 21880 | A | II | 8/14/2008 | FORMOSA LABORATORIES INC | PARICALCITOL |
| 23895 | A | II | 6/18/2010 | NEULAND LABORATORIES LTD | PARICALCITOL, USP |
| 24315 | A | II | 11/30/2010 | ABBVIE INC | PARICALCITOL DRUG SUBSTANCE |
| 25300 | A | II | 9/13/2011 | DISHMAN NETHERLANDS BV | PARICALCITOL |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
