Drug Master Files for: trazodone hydrochloride
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trazodone hydrochloride Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
14047 | I | II | 3/29/1999 | ERREGIERRE SPA | TRAZODONE HYDROCHLORIDE |
15701 | A | II | 11/2/2001 | MYLAN LABORATORIES LTD | TRAZODONE HYDROCHLORIDE USP |
16207 | I | II | 10/25/2002 | VERA LABORATORIES LTD | TRAZODONE HYDROCHLORIDE |
16459 | A | II | 3/10/2003 | TEVA PHARMACEUTICAL INDUSTRIES LTD | TRAZODONE HYDROCHLORIDE USP |
20920 | A | II | 10/4/2007 | PIRAMAL ENTERPRISES LTD | TRAZODONE HYDROCHLORIDE |
27820 | A | II | 12/30/2013 | INTAS PHARMACEUTICALS LTD | TRAZODONE HYDROCHLORIDE USP |
32928 | A | II | 8/31/2018 | CADILA HEALTHCARE LTD | TRAZODONE 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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