Drug Master Files for: phenoxybenzamine hydrochloride
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phenoxybenzamine hydrochloride Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 16593 | I | II | 5/13/2003 | ISP CHEMICALS INC | PHENOXYBENZAMINE HYDROCHLORIDE (PBZA) |
| 20011 | A | II | 11/29/2006 | APICORE US LLC | PHENOXYBENZAMINE HYDROCHLORIDE USP |
| 25580 | A | II | 1/11/2012 | PAR PHARMACEUTICAL INC | PHENOXYBENZAMINE HYDROCHLORIDE USP |
| 31746 | A | II | 12/28/2017 | NAVINTA LLC | PHENOXYBENZAMINE HYDROCHLORIDE USP |
| 32443 | A | II | 1/25/2018 | ESJAY PHARMA LLC | PHENOXYBENZAMINE HYDROCHLORIDE USP |
| 33477 | A | II | 12/27/2018 | AUROBINDO PHARMA LTD | PHENOXYBENZAMINE 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
