Drug Master Files for: DONEPEZIL HYDROCHLORIDE
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DONEPEZIL HYDROCHLORIDE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 15694 | A | II | 10/29/2001 | FINETECH PHARMACEUTICAL LTD | DONEPEZIL HYDROCHLORIDE |
| 16674 | I | II | 6/30/2003 | SUN PHARMACEUTICAL INDUSTRIES LTD | DONEPEZIL HYDROCHLORIDE (MONOHYDRATE) USP |
| 17523 | I | II | 7/8/2004 | PERRIGO API LTD | DONEPEZIL HYDROCHLORIDE (DILUTED) 25% AMORPHOUS |
| 17779 | A | II | 10/26/2004 | DR REDDYS LABORATORIES LTD | DONEPEZIL HYDROCHLORIDE MONOHYDRATE (FORM-1) USP |
| 18422 | A | II | 6/9/2005 | CIPLA LTD | DONEPEZIL HYDROCHLORIDE FORM-I |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
