Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 071810
Company: HOSPIRA
Company: HOSPIRA
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 |
---|---|---|---|---|---|---|---|
12/11/1987 | 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 |
---|---|---|---|---|---|
06/09/2020 | SUPPL-21 | Labeling-Package Insert |
Label is not available on this site. |
||
08/25/2015 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
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04/07/2010 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
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07/15/1997 | SUPPL-8 | Labeling |
Label is not available on this site. |
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08/08/1996 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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11/02/1995 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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02/23/1995 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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06/20/1996 | SUPPL-2 | Manufacturing (CMC) |
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 |