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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076931
Company: HIKMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BUPRENORPHINE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE EQ 0.3MG BASE/ML INJECTABLE;INJECTION Prescription AP No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
03/02/2005 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/15/2020 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

07/12/2019 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

BUPRENORPHINE HYDROCHLORIDE

INJECTABLE;INJECTION; EQ 0.3MG BASE/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BUPRENEX BUPRENORPHINE HYDROCHLORIDE EQ 0.3MG BASE/ML INJECTABLE;INJECTION Prescription Yes AP 018401 INDIVIOR INC
BUPRENORPHINE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE EQ 0.3MG BASE/ML INJECTABLE;INJECTION Prescription No AP 078331 AM REGENT
BUPRENORPHINE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE EQ 0.3MG BASE/ML INJECTABLE;INJECTION Prescription No AP 076931 HIKMA
BUPRENORPHINE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE EQ 0.3MG BASE/ML INJECTABLE;INJECTION Prescription No AP 074137 HOSPIRA
BUPRENORPHINE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE EQ 0.3MG BASE/ML INJECTABLE;INJECTION Prescription No AP 206586 PAR STERILE PRODUCTS
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