Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 071166
Company: HOSPIRA
Company: HOSPIRA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE | BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE | 0.25%;0.005MG/ML | 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 |
|---|---|---|---|---|---|---|---|
| 06/16/1988 | 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 |
|---|---|---|---|---|---|
| 11/22/1999 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 10/03/1990 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 05/04/1990 | SUPPL-4 | Labeling |
Label is not available on this site. |
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| 02/21/1991 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |