Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 070587
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;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 |
|---|---|---|---|---|---|
| 04/27/2010 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
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| 11/02/1999 | SUPPL-13 | Labeling |
Label is not available on this site. |
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| 10/03/1996 | SUPPL-11 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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| 02/23/1995 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/26/1996 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/03/1990 | SUPPL-4 | Labeling |
Label is not available on this site. |
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| 06/22/1990 | SUPPL-3 | Labeling |
Label is not available on this site. |
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| 05/07/1990 | SUPPL-2 | Labeling |
Label is not available on this site. |