Drug Master Files for: prazosin hydrochloride
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prazosin hydrochloride Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 10678 | I | II | 12/15/1993 | CHEMICAL PHARMACEUTICAL RESEARCH INSTITUTE NIHFI LTD | PRAZOSIN HYDROCHLORIDE |
| 15321 | A | II | 2/28/2001 | BIOINDUSTRIA LABORATORIO ITALIANO MEDICINALI SPA | PRAZOSIN HYDROCHLORIDE BULK SUBSTANCE |
| 18234 | I | II | 3/28/2005 | STANDARD CHEM AND PHARM CO LTD | PRAZOSIN HYDROCHLORIDE |
| 31628 | A | II | 6/16/2017 | NOVITIUM PHARMA LLC | PRAZOSIN HYDROCHLORIDE USP |
| 33014 | A | II | 7/31/2018 | MSN ORGANICS PRIVATE LTD | PRAZOSIN HYDROCHLORIDE USP (POLYHYDRATE) |
| 6183 | I | II | 2/6/1986 | HEUMANN PCS GMBH | PRAZOSIN 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
