Drug Master Files for: DIPHENHYDRAMINE HYDROCHLORIDE
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DIPHENHYDRAMINE HYDROCHLORIDE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 11097 | A | II | 9/23/1994 | ALBEMARLE CORP | DIPHENHYDRAMINE CITRATE, USP |
| 12360 | I | II | 1/31/1997 | EURAND AMERICA INC | DIPHENHYDRAMINE CITRATE (MICROCAPS) |
| 1237 | I | II | 9/16/1968 | GANES CHEMICALS INC PENNSVILLE DIV | DIPHENHYDRAMINE HYDROCHLORIDE |
| 19737 | A | II | 9/6/2006 | BEIJING TAIYANG PHARMACEUTICAL INDUSTRY CO LTD | DIPHENHYDRAMINE HYDROCHLORIDE |
| 19986 | A | II | 11/15/2006 | WANBURY LTD | DIPHENHYDRAMINE CITRATE |
| 20334 | A | II | 2/23/2007 | RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA SPA | DIPHENHYDRAMINE CITRATE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
