Drug Master Files for: CEFTAZIDIME
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CEFTAZIDIME Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
13009 | A | II | 5/25/1998 | SANDOZ GMBH | CTAZ.DH (=CEFTAZIDIME DIHYDROCHLORIDE) |
13650 | I | II | 8/10/2000 | GLAXO WELLCOME INC | CEFTAZIDIME PENTAHYDRATE BULK DRUG SUBSTANCE |
13683 | A | II | 9/1/1998 | ACS DOBFAR SPA | CEFTAZIDIME FOR INJECTION (CEFTAZIDIME STERILE BUFFERED) |
16082 | A | II | 8/6/2002 | SANDOZ GMBH | CEFTAZIDIME FOR INJECTION |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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