Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 014127
Company: ASTRAZENECA
Company: ASTRAZENECA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| XYLOCAINE | LIDOCAINE | 5% | 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 |
|---|---|---|---|---|---|---|---|
| 03/11/1964 | ORIG-1 | Approval | Type 3 - New Dosage Form | PRIORITY |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/31/1996 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/18/1993 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/16/1987 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/20/1984 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/25/1982 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 03/25/1985 | SUPPL-2 | Labeling |
Label is not available on this site. |