Drug Master Files for: TERBUTALINE SULFATE
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TERBUTALINE SULFATE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 11927 | A | II | 4/17/1996 | CAMBREX PROFARMACO MILANO SRL | TERBUTALINE SULFATE |
| 26563 | I | II | 9/14/2012 | MELODY HEALTHCARE PVT LTD | TERBUTALINE SULPHATE |
| 4748 | I | II | 11/29/1982 | COSMA SPA | TERBUTALINE SULPHATE |
| 7942 | I | II | 3/1/1989 | ASTRA PHARMACEUTICAL PRODUCTS INC | TERBUTALINE SULPHATE |
| 8062 | A | II | 5/6/1989 | CIPLA LTD | TERBUTALINE SULFATE 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
