Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076931
Company: HIKMA
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 |
---|---|---|---|---|---|---|---|---|
BUPRENORPHINE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE | EQ 0.3MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 206586 | ENDO OPERATIONS |
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 |