Drug Master Files for: fentanyl hydrochloride
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fentanyl hydrochloride Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
10128 | A | II | 3/15/1993 | SPECGX LLC | FENTANYL CITRATE (NEW PROCESS) |
11200 | A | II | 11/15/1994 | JOHNSON MATTHEY INC PHARMACEUTICAL MATERIALS | FENTANYL HYDROCHLORIDE |
14284 | I | II | 6/30/1999 | MALLINCKRODT LLC | FENTANYL HYDROCHLORIDE |
14285 | A | II | 6/30/1999 | SPECGX LLC | FENTANYL ALKALOID |
14966 | I | II | 7/25/2000 | 3M DRUG DELIVERY SYSTEMS DIV | TRANSDERMAL DELIVERY SYSTEM CONTAINING FENTANYL |
16872 | A | II | 9/26/2003 | CAMBREX CHARLES CITY INC | FENTANYL |
17055 | A | II | 12/19/2003 | CAMBREX CHARLES CITY INC | FENTANYL CITRATE 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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