Drug Master Files for: PROCAINAMIDE HYDROCHLORIDE
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PROCAINAMIDE HYDROCHLORIDE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 2133 | I | II | 7/23/1973 | GANES CHEMICALS INC PENNSVILLE DIV | PROCAINAMIDE HYDROCHLORIDE |
| 2188 | I | II | 10/29/1973 | COLLETT MARWELL HAUGE A/S | PROCAINAMIDE S.R. TAB 300 & 500MGS |
| 25461 | A | II | 10/7/2011 | CHENG FONG CHEMICAL CO LTD | PROCAINAMIDE HYDROCHLORIDE |
| 2751 | I | II | 9/17/1976 | NAPP CHEMICALS INC | N-ACETYL PROCAINAMIDE HCL |
| 2887 | I | II | 3/22/1977 | SIEGFRIED AG | N-ACETYL PROCAINAMIDE HCL |
| 33216 | A | II | 9/29/2018 | BIOPHORE INDIA PHARMACEUTICALS PVT LTD | PROCAINAMIDE HYDROCHLORIDE USP |
| 3410 | I | II | 12/20/1978 | HOECHST AG | PROCAINAMIDE HCL, BULK DRUG 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
