Drug Master Files for: guanidine
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guanidine Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
11898 | I | II | 3/11/1996 | CIS US INC | META-IODOBENZYLGUANIDINE SULFATE (MIBG-S) |
17096 | I | II | 12/16/2003 | GE HEALTHCARE | 123I-META-IODOBENZYLGUANIDINE (MIBG) |
2484 | I | II | 7/3/1975 | CIECH POLFA | SULFAGUANIDINE |
2588 | I | 11/28/1975 | EASTMAN KODAK CO | GUANIDINE HCL | |
6757 | I | II | 12/31/1986 | ALDRICH CHEMICAL CO INC | AMINOGUANIDINE HYDROCHLORIDE (W176-2) |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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