Drug Master Files for: benzoyl peroxide
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benzoyl peroxide Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 14834 | A | II | 4/12/2000 | CORDEN PHARMA BERGAMO SPA | BENZOYL PEROXIDE, HYDROUS |
| 15218 | A | II | 12/27/2000 | CAMBREX KARLSKOGA AB | HYDROUS BENZOYL PEROXIDE |
| 15345 | I | II | 3/16/2001 | AKZO NOBEL POLYMER CHEMICALS LLC | PERKADOX API (BENZOYL PEROXIDE) |
| 15748 | A | II | 12/3/2001 | NORAC PHARMA | HYDROUS BENZOYL PEROXIDE, USP |
| 16286 | A | II | 12/4/2002 | AKZO NOBEL CHEMICALS SA DE CV | PERKADOX API (BENZOYL PEROXIDE) |
| 22605 | I | II | 3/9/2009 | AMCOL HEALTH AND BEAUTY SOLUTIONS INC | MICROSPONGE? P009A-13 BENZOYL PEROXIDE (BENZOYL PEROXIDE IN METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER) |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
