Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 085995
Company: HOSPIRA
Company: HOSPIRA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PEDIATRIC LTA KIT | LIDOCAINE HYDROCHLORIDE | 2% | SOLUTION;TOPICAL | 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 |
|---|---|---|---|---|---|---|---|
| 11/17/1977 | 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 |
|---|---|---|---|---|---|
| 05/04/1993 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 06/30/1989 | SUPPL-15 | Labeling |
Label is not available on this site. |
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| 03/20/1989 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/15/1986 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/17/1985 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/13/1983 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/28/1983 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |