Drug Master Files for: NALTREXONE HYDROCHLORIDE
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NALTREXONE HYDROCHLORIDE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 12349 | I | II | 2/5/1997 | TASMANIAN ALKALOIDS PARTY LTD | NALTREXONE BENZOATE |
| 15102 | A | II | 10/18/2000 | ASPEN OSS BV | NALTREXONE HYDROCHLORIDE |
| 15221 | I | II | 1/3/2001 | DIOSYNTH BV | NALTREXONE |
| 15837 | A | II | 1/31/2002 | SPECGX LLC | NALTREXONE METHOBROMIDE |
| 17563 | I | II | 7/20/2004 | NV ORGANON | NALTREXONE |
| 20623 | A | II | 6/20/2007 | SANOFI CHIMIE | NALTREXONE HYDROCHLORIDE |
| 21217 | A | II | 12/28/2007 | SUN PHARMACEUTICAL INDUSTRIES LTD | Naltrexone Hydrochloride USP (Dihydrate Form) |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
