Drug Master Files for: MIDODRINE HYDROCHLORIDE
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MIDODRINE HYDROCHLORIDE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 15610 | I | II | 9/4/2001 | CADILA HEALTHCARE LTD | MIDODRINE HYDROCHLORIDE |
| 16006 | A | II | 6/13/2002 | INDUSTRIALE CHIMICA SRL | MIDODRINE HYDROCHLORIDE |
| 16017 | A | II | 6/21/2002 | EDMOND PHARMA SRL | MIDODRINE HYDROCHLORIDE |
| 16135 | A | II | 9/16/2002 | TEVA PHARMACEUTICAL INDUSTRIES LTD | MIDODRINE HYDROCHLORIDE, NON-STERILE, BULK DRUG SUBSTANCE |
| 16417 | I | II | 2/6/2003 | CHEMAGIS LTD | MIDODRINE HYDROCHLORIDE |
| 16481 | A | II | 3/24/2003 | ALCAMI WISCONSIN CORP | MIDODRINE HYDROCHLORIDE USP |
| 18470 | A | II | 6/30/2005 | APOTEX PHARMACHEM INC | MIDODRINE 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
