Drug Master Files for: CODEINE SULFATE
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CODEINE SULFATE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 10159 | I | II | 3/24/1993 | NORAMCO DELAWARE INC | CODEINE SULFATE |
| 10162 | I | II | 3/24/1993 | NORAMCO DELAWARE INC | CODEINE |
| 12655 | I | II | 9/11/1997 | FINE CHEMICALS CORP | CODEINE PHOSPHATE |
| 191 | A | II | 1/24/1956 | SPECGX LLC | PARZONE BITARTRATE (DIHYDROCODEINE BITARTRATE) |
| 20213 | A | II | 1/29/2007 | SIEGFRIED USA LLC | CODEINE PHOSPHATE USP |
| 207 | I | II | 5/9/1956 | NEW YORK QUININE AND CHEMICAL WORKS INC | DIHYDROCODEINE BITARTRATE ANHYDROUS |
| 20787 | A | II | 8/23/2007 | JOHNSON MATTHEY PHARMACEUTICAL MATERIALS | CODEINE PHOSPHATE 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
