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Abbreviated New Drug Application (ANDA): 206586
Company: PAR STERILE PRODUCTS
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
07/28/2015 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206586Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/23/2020 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

06/23/2020 SUPPL-1 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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