Drug Master Files for: POTASSIUM CITRATE
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POTASSIUM CITRATE Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
10234 | I | II | 5/4/1993 | NORTH CHINA PHARMACEUTICAL CORP | PENICILLIN G POTASSIUM CRUDE |
10301 | I | II | 6/11/1993 | ARCHER DANIELS MIDLAND CO | POTASSIUM CITRATE MONOHYDRATE |
10831 | A | II | 3/24/1994 | YUNG ZIP CHEMICAL IND CO LTD | DICLOFENAC POTASSIUM |
11020 | I | II | 7/31/1994 | DERETIL SA | D(-) ALPHA PHENYLGLYCINE DANE SALT ETHYL NPOTASSIUM |
11021 | I | II | 7/31/1994 | DERETIL SA | D(-) ALPHA PARAHYDROXY PHENYLGLYCINE DANE SALT METHYL POTASSIUM |
11041 | I | II | 6/24/1994 | SMITHKLINE BEECHAM PHARMACEUTICALS CO | PENICILLIN G POTASSIUM, NON-STERILE, TECHNICAL GRADE |
11122 | I | II | 9/30/1994 | DSM ANDENO GMBH | R(-)-2-PHENYLGLYCINE DANE SALT (POTASSIUM, ETHYL) (KE) |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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