Drug Master Files for: ANAGRELIDE HYDROCHLORIDE
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ANAGRELIDE HYDROCHLORIDE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 15971 | A | II | 5/6/2002 | ASH STEVENS INC | ANAGRELIDE HYDROCHLORIDE MONOHYDRATE |
| 16024 | A | II | 6/24/2002 | CIPLA LTD | ANAGRELIDE HYDROCHLORIDE MONOHYDRATE USP |
| 16440 | A | II | 2/25/2003 | CHEMWERTH INC | ANAGRELIDE HYDROCHLORIDE MONOHYDRATE |
| 16531 | A | II | 3/30/2003 | CADILA HEALTHCARE LTD | ANAGRELIDE HYDROCHLORIDE USP |
| 16969 | I | II | 11/12/2003 | AMSA ANONIMA MATERIE SINTETICHE AND AFFINI SPA | ANAGRELIDE HYDROCHLORIDE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
