Drug Master Files for: SOTALOL HYDROCHLORIDE
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SOTALOL HYDROCHLORIDE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 11887 | I | II | 3/6/1996 | IROTEC LABORATORIES | SOTALOL HYDROCHLORIDE |
| 12273 | A | II | 12/17/1996 | CAMBREX PROFARMACO MILANO SRL | SOTALOL HCL |
| 13083 | I | II | 7/21/1998 | ERREGIERRE SPA | SOTALOL HYDROCHLORIDE |
| 13186 | I | II | 9/14/1998 | HEUMANN PHARMA GMBH | SOTALOL HYDROCHLORIDE |
| 13992 | A | II | 2/22/1999 | MOEHS IBERICA SL | SOTALOL HCI |
| 14841 | I | II | 4/20/2000 | SIFAVITOR SRL | SOTALOL HYDROCHLORIDE |
| 14951 | A | II | 7/13/2000 | NEULAND LABORATORIES LTD | SOTALOL HYDROCHLORIDE 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
