Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019978
Company: HOSPIRA
Company: HOSPIRA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BUPIVACAINE HYDROCHLORIDE KIT | BUPIVACAINE HYDROCHLORIDE | 0.075% | INJECTABLE;INJECTION | Discontinued | None | No | No |
| BUPIVACAINE HYDROCHLORIDE KIT | BUPIVACAINE HYDROCHLORIDE | 0.114% | INJECTABLE;INJECTION | Discontinued | None | No | No |
| BUPIVACAINE HYDROCHLORIDE KIT | BUPIVACAINE HYDROCHLORIDE | 0.23% | 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 |
|---|---|---|---|---|---|---|---|
| 09/03/1992 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/21/1999 | SUPPL-6 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 10/23/1998 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/09/1995 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 05/26/1994 | SUPPL-3 | Labeling |
Label is not available on this site. |
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| 02/26/1993 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |