Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 209087
Company: B BRAUN MEDICAL INC
Company: B BRAUN MEDICAL INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
BUPIVACAINE HYDROCHLORIDE | BUPIVACAINE HYDROCHLORIDE | 0.75% | INJECTABLE;SPINAL | 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 |
---|---|---|---|---|---|---|---|
04/02/2019 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
BUPIVACAINE HYDROCHLORIDE
INJECTABLE;SPINAL; 0.75%
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
BUPIVACAINE HYDROCHLORIDE | BUPIVACAINE HYDROCHLORIDE | 0.75% | INJECTABLE;SPINAL | Prescription | No | AP | 209087 | B BRAUN MEDICAL INC |
BUPIVACAINE HYDROCHLORIDE | BUPIVACAINE HYDROCHLORIDE | 0.75% | INJECTABLE;SPINAL | Prescription | No | AP | 071810 | HOSPIRA |
BUPIVACAINE HYDROCHLORIDE | BUPIVACAINE HYDROCHLORIDE | 0.75% | INJECTABLE;SPINAL | Prescription | No | AP | 212822 | HUONS |
MARCAINE | BUPIVACAINE HYDROCHLORIDE | 0.75% | INJECTABLE;SPINAL | Prescription | Yes | AP | 018692 | HOSPIRA |