Drug Master Files for: azithromycin
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azithromycin Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 14079 | I | II | 4/15/1999 | PLIVA DD | MANUFACTURING SITE, PERSONNEL, AND OPERATING PROCEDURES FOR AZITHROMYCIN DIHYDRATE |
| 14480 | I | II | 10/14/1999 | WOCKHARDT LTD | AZITHROMYCIN USP |
| 15261 | A | II | 1/24/2001 | TEVA PHARMACEUTICAL INDUSTRIES LTD | AZITHROMYCIN MONOHYDRATE |
| 15972 | A | II | 5/2/2002 | TEVA PHARMACEUTICAL INDUSTRIES LTD | AZITHROMYCIN DIHYDRATE |
| 15985 | A | II | 5/28/2002 | TEVA PHARMACEUTICAL INDUSTRIES LTD | AZITHROMYCIN N |
| 16268 | I | II | 11/25/2002 | WOCKHARDT LTD | AZITHROMYCIN-FORM I |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
