Drug Master Files for: MANNITOL
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MANNITOL Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 12879 | A | II | 2/26/1998 | ROQUETTE FRERES | MANNITOL USP GRADE (PEARLITOL PF) |
| 14891 | A | IV | 5/16/2000 | ROQUETTE FRERES | MANNITOL, SPRAY DRIED |
| 16362 | I | IV | 1/16/2003 | SPI PHARMA INC | MANNOGEM(TM) EZ SPRAY DRIED MANNITOL USP |
| 171 | I | II | 8/16/1955 | NEW DRUG INSTITUTE | RAUWOLFIA SERPERTINA WHOLE ROOT,MANNITOL HEXANITRATE , |
| 18143 | A | IV | 3/8/2005 | ROQUETTE FRERES | MANNITOL USP POWDER PEARLITOL ? |
| 21783 | A | IV | 6/25/2008 | DUPONT NUTRITION USA INC | AVICEL HFE MICROCRYSTALLINE CELLULOSE AND MANNITOL |
| 27201 | A | II | 7/5/2013 | APOTEX PHARMACHEM INDIA PVT LTD | SAXAGLIPTIN HCI WITH MANNITOL COPRECIPITATE 20% |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
