Drug Master Files for: CALCIUM ACETATE
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CALCIUM ACETATE Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
10232 | I | II | 3/6/1993 | LABOCHIM SPA | LEUCOVORIN CALCIUM |
10238 | I | II | 4/14/1993 | BK LADENBURG GMBH | DENTPHOS C (CALCIUM HYDROXYLAPATITE) |
10759 | I | II | 3/3/1994 | AKZO NOBEL CHEMICALS BV | DISSOLVINE E-CA-10 (EDETATE CALCIUM DISODIUM USP) |
11685 | I | II | 4/20/1995 | SYNTHELABO PHARMACIE | UREA-CALCIUM ACETYLSALICYLATE |
11995 | I | II | 6/10/1996 | MERCK SANTE SAS | CALCIUM ACAMPROSATE NEW DRUG SUBSTANCE |
1262 | I | II | 12/16/1968 | GENERAL ELECTRIC CO | CALCIUM 45, PRODUCT SPECIFICATIONS AND PROCESS DESCRIPTIONS |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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