Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 010496
Company: ASTRAZENECA
Company: ASTRAZENECA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| XYLOCAINE 5% W/ GLUCOSE 7.5% | LIDOCAINE HYDROCHLORIDE | 5% | INJECTABLE;SPINAL | 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 |
|---|---|---|---|---|---|---|---|
| 03/11/1958 | ORIG-1 | Approval | Type 4 - New Combination | 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 |
|---|---|---|---|---|---|
| 03/12/1999 | SUPPL-19 | Labeling |
Label is not available on this site. |
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| 04/06/1995 | SUPPL-18 | Labeling |
Label is not available on this site. |
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| 03/08/1995 | SUPPL-17 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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| 02/18/1993 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/18/1988 | SUPPL-14 | Labeling |
Label is not available on this site. |
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| 09/16/1987 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/28/1982 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/25/1982 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 02/21/1985 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 07/07/1982 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 07/07/1982 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/29/1979 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 05/15/1978 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |