Drug Master Files for: TERAZOSIN HYDROCHLORIDE
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TERAZOSIN HYDROCHLORIDE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 10035 | A | II | 1/11/1993 | CU CHEMIE UETIKON GMBH | TERAZOSIN HYDROCHLORIDE |
| 10054 | I | II | 1/21/1993 | PFC ITALIANA SRL DIV ALFA CHEMICALS ITALIANA | TERAZOSIN HYDROCHLORIDE |
| 10319 | I | II | 6/24/1993 | CATALENT PHARMA SOLUTIONS LLC | HYTRIN (TERAZOSIN) SOFT GELATIN CAPSULES |
| 11300 | A | II | 1/16/1995 | TEVA PHARMACEUTICAL INDUSTRIES LTD | TERAZOSIN HYDROCHLORIDE |
| 11882 | I | II | 3/13/1996 | ORION CORP FERMION | TERAZOSIN HYDROCHLORIDE DIHYDRATE |
| 12244 | I | II | 11/25/1996 | BASF PHARMACHEMIKALIEN GMBH CO KG | TERAZOSIN HYDROCHLORIDE |
| 12424 | I | II | 3/17/1997 | BIOINDUSTRIA | TERAZOSIN HCI. 2H20 BULK SUBSTANCE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
