Drug Master Files for: TAPENTADOL HYDROCHLORIDE
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TAPENTADOL HYDROCHLORIDE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 21084 | A | II | 1/23/2008 | NORAMCO INC | TAPENTADOL HYDROCHLORIDE (R331333) DRUG SUBSTANCE |
| 26490 | A | II | 9/27/2012 | EUTICALS INC | TAPENTADOL HYDROCHLORIDE DRUG SUBSTANCE |
| 26519 | A | II | 10/23/2012 | ALKEM LABORATORIES LTD | TAPENTADOL HYDROCHLORIDE |
| 28541 | A | II | 9/25/2014 | AMPAC FINE CHEMICALS LLC | TAPENTADOL HCI |
| 31435 | A | II | 3/27/2017 | ALKEM LABORATORIES LTD | TAPENTADOL HYDROCHLORIDE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
