Drug Master Files for: Alkermes Inc
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Alkermes Inc Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 12571 | A | II | 7/9/1997 | ALKERMES INC | RAPAMYCIN NANOCRYSTAL COLLOIDAL DISPERSION-MEDIA MILLING PROCESS |
| 13957 | I | II | 1/22/1999 | ALKERMES INC | FLUVOXAMINE MALEATE CR CAPSULES |
| 14028 | I | II | 3/18/1999 | ALKERMES INC | PROLEASE DILUENT USED FOR SUSPENSION OF PROLEASE MICROSPHERE PRODUCTS FOR PRODUCT ADMINISTRATION |
| 16364 | I | III | 1/16/2003 | ALKERMES INC | C2S DRY POWDER INHALER DRUG DELIVERY SYSTEMS |
| 16433 | I | II | 2/21/2003 | ALKERMES INC | AVINZA((R) (MORPHINE SULFATE EXTENDED-RELEASE CAPSULES) 30MG, 45MG, 60MG, 75MG, 90MG AND 120MG |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
