Drug Master Files for: NALOXEGOL OXALATE
NALOXEGOL OXALATE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 32535 | A | II | 3/3/2018 | MSN LIFE SCIENCES PRIVATE LTD | NALOXEGOL OXALATE |
| 32562 | A | II | 3/21/2018 | MSN LIFE SCIENCES PRIVATE LTD | NALOXEGOL OXALATE (PREMIX) |
| 33405 | A | II | 12/1/2018 | AUROBINDO PHARMA LTD | NALOXEGOL OXALATE PREMIX |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
