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BUPRENORPHINE HYDROCHLORIDE

ANDA

BUPRENORPHINE HYDROCHLORIDE | A206586 | PH HEALTH LTD

1 strength0 unique patents0 unique exclusivities

API Supply Chain14 active DMFs4 inactive

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

ASPEN OSS BVBUPRENORPHINE HYDROCHLORIDE

DMF 70991987

TAPI NL BVBUPRENORPHINE HYDROCHLORIDE

DMF 164192003

MACFARLAN SMITH LTDBUPRENORPHINE HYDROCHLORIDE

DMF 191092006

SIEGFRIED LTDBUPRENORPHINE HYDROCHLORIDE

DMF 210602007

SUN PHARMACEUTICAL INDUSTRIES LTDBUPRENORPHINE HYDROCHLORIDE USP

DMF 228562009

UNICHEM LABORATORIES LTDBUPRENORPHINE HYDROCHLORIDE USP

DMF 228872009

NORAMCO LLCBUPRENORPHINE HYDROCHLORIDE (R036869) DRUG SUBSTANCE

DMF 236832010

AREVIPHARMA GMBHBUPRENORPHINE HYDROCHLORIDE

DMF 245942011

SPECGX LLCBUPRENORPHINE HYDROCHLORIDE USP, CODE 3210

DMF 249272012

SIEGFRIED USA LLCBUPRENORPHINE HYDROCHLORIDE USP

DMF 255072011

CAMBREX CHARLES CITY INCBUPRENORPHINE HYDROCHLORIDE

DMF 337992023

CHATTEM CHEMICALS INCBUPRENORPHINE HYDROCHLORIDE USP

DMF 351922021

SIEGFRIED AGBUPRENORPHINE HYDROCHLORIDE

DMF 388392024

AREVIPHARMA GMBHBUPRENORPHINE HYDROCHLORIDE

DMF 401952024

MACFARLAN SMITH LTDInactiveBUPRENORPHINE HYDROCHLORIDE

DMF 73431988

SALARS SPAInactiveBUPRENORPHINE HYDROCHLORIDE

DMF 76841988

UNICHEM LABORATORIES LTDInactiveBUPRENORPHINE HYDROCHLORIDE

DMF 79231989

RESONANCE LABORATORIES PVT LTDInactiveBUPRENORPHINE HYDROCHLORIDE (BPNH)

DMF 237562010

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jul 30, 2015	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 0.3MG BASE/ML

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Jul 28, 2015

No patent or exclusivity listings for this strength.