Drug Master Files for: ISOPROTERENOL SULFATE
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ISOPROTERENOL SULFATE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 1227 | I | II | 9/3/1968 | CILAG CHEMIE AG | MANUF FACILS AND CONTROLS FOR ISOPROTERENOL HYDROCHLORIDE |
| 25212 | A | II | 8/16/2011 | HOSPIRA BOULDER INC | ISOPROTERENOL HYDROCHLORIDE DRUG SUBSTANCE |
| 2697 | I | II | 6/9/1976 | GANES CHEMICALS INC PENNSVILLE DIV | ISOPROTERENOL HCL AND ISOPROTERENOL SULFATE |
| 27469 | A | II | 9/30/2013 | CIVENTICHEM LLC | ISOPROTERENOL HYDROCHLORIDE USP |
| 29717 | A | II | 11/19/2015 | SAI LIFE SCIENCES LTD | ISOPROTERENOL HYDROCHLORIDE USP |
| 29732 | A | II | 9/28/2015 | MICRO LABS LTD | ISOPROTERENOL HYDROCHLORIDE USP |
| 29876 | A | II | 11/9/2015 | AMPHASTAR NANJING PHARMACEUTICALS INC | ISOPROTERENOL 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
