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. |