Drug Master Files for: DOXERCALCIFEROL
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DOXERCALCIFEROL Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
15357 | A | II | 4/12/2001 | TEVA PHARMACEUTICAL INDUSTRIES LTD | DOXERCALCIFEROL DRUG SUBSTANCE |
15397 | I | II | 4/19/2001 | CEDARBURG PHARMACEUTICALS LLC | DOXERCALCIFEROL |
22120 | A | II | 10/27/2008 | SAI LIFE SCIENCES LTD | DOXERCALCIFEROL USP |
22136 | A | II | 10/31/2008 | FORMOSA LABORATORIES INC | DOXERCALCIFEROL |
22590 | A | II | 3/5/2009 | POLYMED THERAPEUTICS INC | DOXERCALCIFEROL DRUG SUBSTANCE |
23233 | A | II | 4/7/2010 | LUPIN LTD | DOXERCALCIFEROL |
25148 | A | II | 3/4/2011 | ALP PHARM BEIJING CO LTD | DOXERCALCIFEROL |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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