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BUPRENORPHINE

ANDA

BUPRENORPHINE | A211586 | AMNEAL PHARMACEUTICALS LLC

5 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: BUTRANS(TE code: AB)

API Supply Chain12 active DMFs3 inactive

10 active API suppliers hold Drug Master Files for this ingredient.

INDIVIOR UK LTDBUPRENORPHINE HCI

DMF 124121997

NORAMCO LLCBUPRENORPHINE BASE (R371605) DRUG SUBSTANCE

DMF 236842010

SPECGX LLCBUPRENORPHINE BASE EP, CODE 3205

DMF 249282012

SIEGFRIED LTDBUPRENORPHINE

DMF 260522012

MACFARLAN SMITH LTD A JOHNSON MATTHEY COBUPRENORPHINE

DMF 264482012

AREVIPHARMA GMBHBUPRENORPHINE

DMF 275472013

TAPI NL BVBUPRENORPHINE

DMF 280752014

SIEGFRIED USA LLCBUPRENORPHINE

DMF 290912015

NORAMCO LLCBUPRENORPHINE HYDROCHLORIDE, USP

DMF 298852016

NORAMCO LLCBUPRENORPHINE

DMF 307622016

SUN PHARMACEUTICAL INDUSTRIES LTDBUPRENORPHINE BASE

DMF 330972019

CHR OLESEN SYNTHESIS ASBUPRENORPHINE HCl USP

DMF 359882021

DIOSYNTH BVInactiveBUPRENORPHINE

DMF 85421990

TASMANIAN ALKALOIDS PTY LTDInactiveBUPRENORPHINE BASE

DMF 118601996

TASMANIAN ALKALOIDS PROPRIETARY LTDInactiveBUPRENORPHINE BASE DRUG SUBSTANCE

DMF 151262000

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
May 19, 2020	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.