Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 010796
Company: ABBVIE
Company: ABBVIE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HARMONYL | DESERPIDINE | 0.1MG | TABLET;ORAL | Discontinued | None | No | No |
| HARMONYL | DESERPIDINE | 0.25MG | TABLET;ORAL | 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 |
|---|---|---|---|---|---|---|---|
| 04/19/1957 | ORIG-1 | Approval | Type 1 - New Molecular Entity | 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 |
|---|---|---|---|---|---|
| 03/05/1984 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 12/15/1983 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/25/1991 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 07/16/1982 | SUPPL-10 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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| 07/16/1982 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 01/28/1980 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 03/13/2009 | SUPPL-7 | Labeling |
Label is not available on this site. |