Drug Master Files for: CEFPODOXIME PROXETIL
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CEFPODOXIME PROXETIL Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 15192 | I | II | 12/18/2000 | SUN PHARMACEUTICAL INDUSTRIES LTD | CEFPODOXIME PROXETIL USP |
| 15194 | I | II | 12/18/2000 | SUN PHARMACEUTICAL INDUSTRIES LTD | CEFPODOXIME ACID |
| 16542 | I | II | 4/15/2003 | SANDOZ PRIVATE LTD | CEFPODOXIME PROXETIL |
| 18505 | A | II | 7/11/2005 | ORCHID PHARMA LTD | CEFPODOXIME PROXETIL USP (NON-STERILE BULK) |
| 18941 | A | II | 10/31/2005 | AUROBINDO PHARMA LTD | CEFPODOXIME PROXETIL 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
