Drug Master Files for: doxylamine succinate
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doxylamine succinate Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 17417 | I | II | 5/21/2004 | UQUIFA ITALIA SPA | DOXYLAMINE SUCCINATE USP |
| 28027 | A | II | 2/6/2014 | RL FINE CHEM PVT LTD | DOXYLAMINE SUCCINATE |
| 31831 | A | II | 6/14/2017 | SHENZHEN ORIENTAL PHARMACEUTICAL CO LTD | DOXYLAMINE SUCCINATE |
| 3652 | I | II | 11/29/1979 | HOFFMANN LA ROCHE INC | DOXYLAMINE SUCCINATE |
| 3673 | I | II | 12/7/1979 | BURDICK & JACKSON LABS,INC | DOXYLAMINE SUCCINATE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
