Drug Master Files for: naloxone hydrochloride
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naloxone hydrochloride Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 14034 | A | II | 3/19/1999 | ASPEN OSS BV | NALOXONE HYDROCHLORIDE |
| 1862 | A | II | 1/25/1972 | SPECGX LLC | NALOXONE HCL USP DIHYDRATE |
| 20745 | A | II | 7/31/2007 | MACFARLAN SMITH LTD | Naloxone Hydrochloride |
| 23142 | A | II | 9/30/2009 | SANOFI CHIMIE | NALOXONE HYDROCHLORIDE |
| 23389 | A | II | 2/22/2010 | SUN PHARMACEUTICAL INDUSTRIES LTD | NALOXONE HYDROCHLORIDE DIHYDRATE USP |
| 24633 | A | II | 2/15/2011 | NORAMCO GMBH | NALOXONE HYDROCHLORIDE DRUG SUBSTANCE |
| 24668 | A | II | 2/24/2011 | SIEGFRIED LTD | NALOXONE HYDROCHLORIDE DIHYDRATE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
