Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 005545
Company: ABBVIE
Company: ABBVIE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DICUMAROL | DICUMAROL | 25MG | TABLET;ORAL | Discontinued | None | No | No |
| DICUMAROL | DICUMAROL | 50MG | TABLET;ORAL | Discontinued | None | No | No |
| DICUMAROL | DICUMAROL | 100MG | 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 |
|---|---|---|---|---|---|---|---|
| 07/31/1944 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/14/1998 | SUPPL-18 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/25/1987 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 08/14/1986 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/26/1985 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/01/1982 | SUPPL-14 | Labeling |
Label is not available on this site. |
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| 08/10/1982 | SUPPL-13 | Labeling |
Label is not available on this site. |
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| 06/10/1982 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/10/1982 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/23/1977 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 12/18/1975 | SUPPL-7 | Labeling |
Label is not available on this site. |