Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 008048
Company: ASTRAZENECA
Company: ASTRAZENECA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| XYLOCAINE | LIDOCAINE | 5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | OINTMENT;TOPICAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 05/17/1951 | ORIG-1 | Approval | Type 2 - New Active Ingredient | 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 |
|---|---|---|---|---|---|
| 12/04/2000 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/02/1996 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/02/1996 | SUPPL-15 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/31/1996 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/18/1993 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/11/1991 | SUPPL-12 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/27/1990 | SUPPL-11 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/07/1987 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/16/1987 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/24/1986 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 06/15/1984 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/25/1982 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/21/1985 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 06/16/1980 | SUPPL-4 | Labeling |
Label is not available on this site. |