Drug Master Files for: talc
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talc Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
14009 | I | III | 2/4/1999 | AMPACET CORP | 110733 WHITE TALC POLYETHYLENE MASTERBATCH |
14598 | I | III | 11/18/1999 | AMPACET CORP | 10799-A TALC POLYETHYLENE MASTERBATCH |
1829 | I | II | 11/22/1971 | CHEMICAL CORP AMERICA INC | CADOX BCP - SILICA - TALC |
26172 | A | II | 6/7/2012 | CHONGQING PHARSCIN PHARMACEUTICAL CO LTD | HYDROTALCITE NON STERILE, DRUG SUBSTANCE |
28604 | A | III | 9/8/2014 | POLYPACIFIC PTY LTD | PROPAK 7021 40% TALC FILLED POLYPROPYLENE HOMOPOLYMER COMPOUND |
33391 | A | IV | 12/8/2018 | NEELKANTH MINECHEM | TALCUM POWDER IP/BP/USP |
5393 | I | II | 5/31/1984 | A INC | A QAE-CELLULOSE-1 ION EXCHG.MEDIA(STAFFORD SPRINGS & TALCOTTVILLE,CT |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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