Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074137
Company: HOSPIRA
Company: HOSPIRA
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 |
---|---|---|---|---|---|---|---|
06/03/1996 | 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 |
---|---|---|---|---|---|
06/12/2024 | SUPPL-40 | Labeling-Package Insert |
Label is not available on this site. |
||
06/12/2024 | SUPPL-36 | Labeling-Package Insert |
Label is not available on this site. |
||
06/12/2024 | SUPPL-28 | Labeling-Package Insert |
Label is not available on this site. |
||
06/12/2024 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
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07/21/2005 | SUPPL-8 | Labeling |
Label is not available on this site. |
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02/05/2003 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
02/14/2001 | SUPPL-3 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
12/02/1996 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
12/02/1996 | SUPPL-1 | Manufacturing (CMC) |
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 |
BUPRENORPHINE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE | EQ 0.3MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 219302 | SOMERSET THERAPS LLC |