Drug Master Files for: betaine
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betaine Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 11069 | I | II | 9/8/1994 | AMINO GMBH | BETAINE, MONOHYDRATE |
| 11079 | A | II | 9/8/1994 | AMINO GMBH | BETAINE |
| 31655 | A | II | 3/28/2017 | AMINO GMBH | BETAINE PHARMACEUTICAL GRADE |
| 5082 | I | II | 9/30/1983 | SIGMA F AND D DIV LTD | BETAINE FREE BASE ANHYDROUS PURCHASED BY SIGMA LTD LONDON FOR USA |
| 7739 | I | II | 10/18/1988 | AMINO GMBH | BETAINE HCl |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
