Drug Master Files for: trientine hydrochloride
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trientine hydrochloride Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 12659 | A | II | 9/18/1997 | AMRI RENSSELAER INC | TRIENTINE HCL USP |
| 29019 | A | II | 9/25/2015 | CHEMWERTH INC | TRIENTINE HYDROCHLORIDE USP |
| 29085 | A | II | 8/27/2015 | TEVA PHARMACEUTICAL INDUSTRIES LTD | TRIENTINE HYDROCHLORIDE USP |
| 29527 | A | II | 9/3/2015 | BIOPHORE INDIA PHARMACEUTICALS PVT LTD | TRIENTINE HYDROCHLORIDE |
| 30878 | A | II | 11/8/2016 | ESJAY PHARMA LLC | TRIENTINE HYDROCHLORIDE USP |
| 30905 | A | II | 9/15/2016 | NAVINTA LLC | TRIENTINE 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
