Drug Master Files for: GE HEALTHCARE
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GE HEALTHCARE Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
16799 | I | II | 8/29/2003 | GE HEALTHCARE | KVICK(TM) ULTRAFILTRATION CASSETTES |
17096 | I | II | 12/16/2003 | GE HEALTHCARE | 123I-META-IODOBENZYLGUANIDINE (MIBG) |
18196 | I | II | 3/21/2005 | GE HEALTHCARE BIO SCIENCES CORP | HOLLOW FIBER TANGENTIAL CARTRIDGE |
19003 | I | II | 11/11/2005 | GE HEALTHCARE BIO SCIENCES CORP | BF-1400 FILM CELLBAG(R) |
21995 | A | V | 9/19/2008 | GE HEALTHCARE INC | FASTLAB PET SYNTHESIZER |
22696 | A | II | 4/3/2009 | GE HEALTHCARE INC | FASTLAB FDG CASSETTE PACK |
22838 | A | II | 6/4/2009 | GE HEALTHCARE INC | FASTLAB NAF CASSETTE PACK |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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