Drug Master Files for: PROMETHAZINE HYDROCHLORIDE
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PROMETHAZINE HYDROCHLORIDE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 11888 | A | II | 3/8/1996 | SIGMA ALDRICH IRELAND LTD | PROMETHAZINE HYDROCHLORIDE |
| 18173 | I | II | 3/2/2005 | WANBURY LTD | PROMETHAZINE HYDROCHLORIDE |
| 1949 | A | II | 6/9/1972 | SANOFI CHIMIE | PROMETHAZINE HCL |
| 1955 | I | II | 6/19/1972 | NAPP CHEMICALS INC | PROMETHAZINE HCL (THIS D ORIG HELD BY VITAMERICAN CORP BY DOLDER LTD |
| 1974 | I | II | 8/2/1972 | PHENCHEM INDUSTRIES LTD | PROMETHAZINE HYDROCHLORIDE |
| 19840 | A | II | 10/9/2006 | CADILA HEALTHCARE LTD | PROMETHAZINE HYDROCHLORIDE |
| 25806 | A | II | 3/27/2012 | EMCURE PHARMACEUTICALS LTD | PROMETHAZINE 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
