Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 012302
Company: ABBVIE
Company: ABBVIE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CHOLOXIN | DEXTROTHYROXINE SODIUM | 2MG | TABLET;ORAL | Discontinued | None | No | No |
| CHOLOXIN | DEXTROTHYROXINE SODIUM | 4MG | TABLET;ORAL | Discontinued | None | No | No |
| CHOLOXIN | DEXTROTHYROXINE SODIUM | 1MG | TABLET;ORAL | Discontinued | None | No | No |
| CHOLOXIN | DEXTROTHYROXINE SODIUM | 6MG | 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 |
|---|---|---|---|---|---|---|---|
| 04/14/1967 | ORIG-1 | Approval | Type 2 - New Active Ingredient | PRIORITY |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/20/1989 | SUPPL-45 | Labeling |
Label is not available on this site. |
||
| 05/02/1984 | SUPPL-44 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 10/03/1988 | SUPPL-43 | Labeling |
Label is not available on this site. |
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| 04/13/1982 | SUPPL-42 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/17/1980 | SUPPL-39 | Labeling |
Label is not available on this site. |
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| 10/12/1978 | SUPPL-32 | Labeling |
Label is not available on this site. |
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| 10/03/1975 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |