Drug Master Files for: SALMETEROL XINAFOATE
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SALMETEROL XINAFOATE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 15706 | I | II | 11/8/2001 | CIPLA LTD | SALMETEROL XINAFOATE |
| 18378 | A | II | 5/26/2005 | CIPLA LTD | SALMETEROL XINAFOATE |
| 18394 | A | II | 6/3/2005 | NATCO PHARMA LTD | SALMETEROL XINAFOATE |
| 21859 | A | II | 8/5/2008 | MYLAN LABORATORIES LTD | SALMETEROL XINAFOATE USP |
| 22054 | A | II | 10/3/2008 | AARTI INDUSTRIES LTD | SALMETEROL XINAFOATE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
