Drug Master Files for: ADEFOVIR DIPIVOXIL
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ADEFOVIR DIPIVOXIL Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 20192 | I | II | 3/27/2007 | CIPLA LTD | ADEFOVIR DIPIVOXIL |
| 23844 | A | II | 6/3/2010 | SIGMAPHARM LABORATORIES LLC | AMORPHOUS ADEFOVIR DIPIVOXIL (11.6% COPOVIDONE DISPERSION) |
| 23993 | I | II | 7/26/2010 | SUN PHARMACEUTICAL INDUSTRIES LTD | ADEFOVIR DIPIVOXIL |
| 24151 | A | II | 8/28/2010 | ZHEJIANG CHARIOTEER PHARMACEUTICAL CO LTD | ADEFOVIR DIPIVOXIL DMC (ADVANCE INTERMEDIATE) |
| 24336 | I | II | 10/21/2010 | ALP PHARM BEIJING CO LTD | ADEFOVIR DIPIVOXIL |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
