Drug Master Files for: QUINIDINE POLYGALACTURONATE
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QUINIDINE POLYGALACTURONATE Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
12334 | I | II | 1/24/1997 | PT SINKONA INDONESIA LESTARI | QUINIDINE GLUCONATE |
2083 | I | II | 3/8/1973 | GYMA LABORATORIES AMERICA INC | HYDROQUINIDINE ALGINATE |
2723 | I | II | 8/5/1976 | SOCIETE CHIMIQUE POINTET GIRARD SA | QUINIDINE GLUCONATE |
2759 | I | II | 8/10/1976 | BUCHLER AND CO | QUINIDINE SULFATE AND QUINIDINE PRODUCTS |
2832 | I | II | 1/28/1977 | LAKE AND CRUICKSHANK | QUINIDINE PRODUCTS |
2871 | I | II | 2/18/1977 | PLANTEX LTD CHEMICAL AND PHARMACEUTICAL WORKS | QUINIDINE SULFATE |
2902 | I | II | 4/19/1977 | SOCIETE CHIMIQUE POINTET GIRARD SA | QUINIDINE SULFATE |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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