Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020575
Company: NOVEN
Company: NOVEN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DENTIPATCH | LIDOCAINE | 23MG/PATCH | FILM, EXTENDED RELEASE;BUCCAL | Discontinued | None | No | No |
| DENTIPATCH | LIDOCAINE | 46.1MG/PATCH | PATCH;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 |
|---|---|---|---|---|---|---|---|
| 05/21/1996 | 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 |
|---|---|---|---|---|---|
| 10/30/2001 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/12/2001 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 03/11/1999 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 09/04/1998 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 09/04/1998 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |