Drug Master Files for: EPHEDRINE SULFATE
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EPHEDRINE SULFATE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 1002 | I | 10/13/1966 | NYSCO LABS INC | PSEUDOEPHEDRINE HCL TIMED RELEASE PELLETS | |
| 10320 | A | II | 6/24/1993 | MALLADI DRUGS AND PHARMACEUTICALS LTD | D-PSEUDOEPHEDRINE HYDROCHLORIDE |
| 10440 | I | II | 8/24/1993 | WYCKOFF CHEMICAL CO INC | PSEUDOEPHEDRINE SULFATE |
| 11665 | I | II | 9/15/1995 | EURAND AMERICA INC | MICROCAPS PSEUDOEPHEDRINE HCL |
| 11843 | I | II | 2/5/1996 | EURAND INTERNATIONAL SPA | DIFFUCAPS PSEUDOEPHEDRINE HCL BULK PELLETS |
| 12017 | I | II | 6/27/1996 | ICN CZECH REPUBLIC AS | L-EPHEDRINE HYDROCHLORIDE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
