Drug Master Files for: pentoxifylline
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pentoxifylline Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 10374 | I | II | 7/21/1993 | ZENTIVA AS | PENTOXIFYLLINE |
| 11549 | I | II | 6/9/1995 | PLANTEX LTD | PENTOXIFYLLINE |
| 12562 | A | II | 6/26/1997 | TEVA PHARMACEUTICAL INDUSTRIES LTD | PENTOXIFYLLINE USP |
| 14182 | A | II | 6/1/1999 | HIKAL LTD | PENTOXIFYLLINE |
| 14987 | A | II | 7/25/2000 | SUN PHARMACEUTICAL INDUSTRIES LTD | PENTOXIFYLLINE USP |
| 17345 | I | II | 4/22/2004 | IPCA LABORATORIES LTD | PENTOXIFYLLINE |
| 18249 | A | II | 3/29/2005 | AUROBINDO PHARMA LTD | PENTOXIFYLLINE 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
