Drug Master Files for: BUPRENORPHINE HYDROCHLORIDE

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BUPRENORPHINE HYDROCHLORIDE Drug Master Files

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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
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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

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