Drug Master Files for: aminophylline
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aminophylline Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
2956 | I | II | 6/21/1977 | GANES CHEMICALS INC PENNSVILLE DIV | AMINOPHYLLINE, USP XIX, BULK POWDER |
3962 | I | II | 9/25/1980 | BOEHRINGER MANNHEIM GMBH | AMINOPHYLLINE,ANHYDROUS(THEOPHYLLINE ETHYLENEDIAMINE,ANHYDROUS) |
3966 | I | II | 9/26/1980 | BOEHRINGER MANNHEIM GMBH | AMINOPHYLLINE, HYDROUS (THEOPHYLLINE ETHYLENEDIAMINE, HYDROUS) |
4917 | I | II | 4/18/1983 | KNOLL AG LUDWIGSHAFEN | AMINOPHYLLINE |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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