Drug Master Files for: buprenorphine hydrochloride
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buprenorphine hydrochloride Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 11860 | I | II | 2/19/1996 | TASMANIAN ALKALOIDS PARTY LTD | BUPRENORPHINE BASE |
| 12412 | A | II | 3/10/1997 | INDIVIOR UK LTD | BUPRENORPHINE HCI |
| 15126 | I | II | 11/2/2000 | TASMANIAN ALKALOIDS PROPRIETARY LTD | BUPRENORPHINE BASE DRUG SUBSTANCE |
| 16419 | A | II | 1/29/2003 | TEVA PHARMACEUTICAL INDUSTRIES LTD | BUPRENORPHINE HYDROCHLORIDE |
| 19109 | A | II | 1/12/2006 | MACFARLAN SMITH LTD | BUPRENORPHINE HYDROCHLORIDE |
| 21060 | A | II | 11/12/2007 | SIEGFRIED LTD | BUPRENORPHINE HYDROCHLORIDE |
| 22856 | A | II | 8/27/2009 | SUN PHARMACEUTICAL INDUSTRIES LTD | BUPRENORPHINE 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
