Drug Master Files for: HYDROMORPHONE HYDROCHLORIDE
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HYDROMORPHONE HYDROCHLORIDE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 12098 | A | II | 8/20/1996 | JOHNSON MATTHEY PHARMACEUTICAL MATERIALS | HYDROMORPHONE HCL |
| 16351 | A | II | 12/6/2002 | RHODES TECHNOLOGIES | HYDROMORPHONE HYDROCHLORIDE USP |
| 17501 | A | II | 6/14/2004 | CODY LABORATORIES INC | HYDROMORPHONE HYDROCHOLORIDE USP |
| 18834 | I | II | 9/30/2005 | MALLINCKRODT INC THE PHARMACEUTICALS BUSINESS OF COVIDIEN | HYDROMORPHONE BASE |
| 19561 | A | II | 6/29/2006 | NORAMCO INC | HYDROMORPHONE HYDROCHLORIDE DRUG SUBSTANCE |
| 19846 | A | II | 10/6/2006 | JOHNSON MATTHEY PHARMACEUTICAL MATERIALS | HYDROMORPHONE HCI, USP |
| 22082 | A | II | 10/1/2008 | SIEGFRIED USA LLC | HYDROMORPHONE HYDROCHLORIDE 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
