Drug Master Files for: DESMOPRESSIN ACETATE
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DESMOPRESSIN ACETATE Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
10175 | A | II | 3/30/1993 | ASPEN OSS BV | DESMOPRESSIN |
10283 | I | II | 6/10/1993 | BACHEM FEINCHEMIKALIEN AG | DESMOPRESSIN ACETATE |
14362 | I | II | 8/24/1999 | BACHEM INC | DESMOPRESSIN |
16813 | A | II | 9/3/2003 | POLYPEPTIDE SA | DESMOPRESSIN (ACETATE) (CODE SF278) |
16947 | A | II | 11/7/2003 | TEVA PHARMACEUTICAL INDUSTRIES LTD | DESMOPRESSIN ACETATE USP |
19334 | A | II | 4/6/2006 | BCN PEPTIDES SA | DESMOPRESSIN ACETATE |
20752 | I | II | 7/28/2007 | SINOPEP PHARMACEUTICAL INC | DESMOPRESSIN ACETATE, NON-STERILE DRUG SUBSTANCE |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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