Drug Master Files for: GUANFACINE HYDROCHLORIDE
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GUANFACINE HYDROCHLORIDE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 28049 | A | II | 3/7/2014 | JUBILANT GENERICS LTD | GUANFACINE HYDROCHLORIDE USP |
| 28312 | A | II | 5/19/2014 | PROCOS SPA | GUANFACINE HYDROCHLORIDE |
| 28443 | A | II | 8/4/2014 | TORRENT PHARMACEUTICALS LTD | GUANFACINE HYDROCHLORIDE USP |
| 4784 | I | II | 12/6/1982 | SANDOZ LTD PHARMACEUTICAL DIV CHEMICAL DEVELOPMENT | GUANFACINE HCL |
| 4985 | I | II | 4/22/1983 | SANDOZ PHARMACEUTICALS CORP DIV SANDOZ INC | GUANFACINE HYDROCHLORIDE |
| 8590 | A | II | 6/12/1990 | MEDICHEM SA | GUANFACINE 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
