Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 070586
Company: HOSPIRA
Company: HOSPIRA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BUPIVACAINE HYDROCHLORIDE | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE;INJECTION | Discontinued | None | 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 |
|---|---|---|---|---|---|---|---|
| 03/03/1987 | 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 |
|---|---|---|---|---|---|
| 07/06/2021 | SUPPL-24 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/09/2020 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
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| 12/09/2020 | SUPPL-20 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/18/2015 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
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| 04/27/2010 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
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| 11/02/1999 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 10/03/1996 | SUPPL-7 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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| 06/18/1996 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/25/1990 | SUPPL-3 | Labeling |
Label is not available on this site. |
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| 06/22/1990 | SUPPL-2 | Labeling |
Label is not available on this site. |
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| 05/07/1990 | SUPPL-1 | Labeling |
Label is not available on this site. |