Drug Master Files for: CLONIDINE HYDROCHLORIDE
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CLONIDINE HYDROCHLORIDE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 12866 | A | II | 2/9/1998 | SOCIETA ITALIANA MEDICINALI SCANDICCI SIMS SRL | CLONIDINE BASE |
| 12964 | A | II | 4/27/1998 | PCAS | CLONIDINE BASE |
| 16601 | A | II | 5/21/2003 | PCAS | APRACLONIDINE HYDROCHLORIDE |
| 16768 | A | II | 8/18/2003 | FORMOSA LABORATORIES INC | APRACLONIDINE HYDROCHLORIDE |
| 16929 | A | II | 10/6/2003 | UNICHEM LABORATORIES LTD | CLONIDINE HYDROCHLORIDE USP |
| 21935 | A | II | 9/5/2008 | CADILA HEALTHCARE LTD | CLONIDINE |
| 22362 | A | II | 12/24/2008 | ALEMBIC PHARMACEUTICALS LTD | CLONIDINE HYDROCHLORIDE USP |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
