Drug Master Files for: MODAFINIL
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MODAFINIL Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 11806 | I | II | 1/15/1996 | ORSYMONDE | MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES OF MODAFINIL DRUG SUBSTANCE IN MITRY-MORY MITRY-MORY CEDEX FRANCE. |
| 11970 | A | II | 5/15/1996 | CEPHALON INC | MODAFINIL DRUG SUBSTANCE |
| 16140 | I | II | 9/19/2002 | WAVELENGTH ENTERPRISES LTD | MODAFINIL |
| 16250 | A | II | 11/19/2002 | DIPHARMA FRANCIS SRL | MODAFINIL USP |
| 16306 | A | II | 12/12/2002 | MYLAN LABORATORIES LTD | MODAFINIL USP |
| 16310 | A | II | 12/13/2002 | TEVA PHARMACEUTICAL INDUSTRIES LTD | MODAFINIL |
| 16477 | A | II | 3/21/2003 | ALEMBIC PHARMACEUTICALS LTD | MODAFINIL 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
