Drug Master Files for: galantamine hydrobromide
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galantamine hydrobromide Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 14425 | I | II | 9/29/1999 | JANSSEN PHARMACEUTICA NV | GALANTAMINE HYDROBROMIDE |
| 15384 | A | II | 5/8/2001 | JANSSEN PHARMACEUTICA NV | GALANTAMINE HYDROBROMIDE DRUG SUBSTANCE(SYNTHETIC) |
| 17863 | A | II | 12/1/2004 | SCINOPHARM TAIWAN LTD | GALANTAMINE HYDROBROMIDE USP |
| 17967 | I | II | 1/3/2005 | WUHAN SHIJI PHARMACEUTICAL CO LTD | GALANTAMINE HYDROBROMIDE |
| 17972 | A | II | 1/5/2005 | ZHEJIANG YIXIN PHARMACEUTICAL CO LTD | GALANTAMINE HBR. |
| 18013 | A | II | 1/20/2005 | DR REDDYS LABORATORIES LTD | GALANTAMINE HYDROBROMIDE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
