Drugs@FDA: FDA-Approved Drugs
Company: ACCORD HLTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| METHYLDOPA | METHYLDOPA | 500MG | 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 |
|---|---|---|---|---|---|---|---|
| 10/15/1985 | 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 |
|---|---|---|---|---|---|
| 09/21/2011 | SUPPL-29 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 09/10/1999 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
| 07/12/1999 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/19/1999 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/11/1998 | SUPPL-25 | Labeling |
Label is not available on this site. |
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| 02/18/1997 | SUPPL-24 | Labeling |
Label is not available on this site. |
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| 08/31/1995 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/31/1995 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/30/1993 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 08/31/1992 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/20/1991 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 12/12/1990 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 08/14/1989 | SUPPL-16 | Bioequivalence |
Label is not available on this site. |
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| 11/21/1990 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/21/1990 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/02/1988 | SUPPL-12 | Labeling |
Label is not available on this site. |
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| 01/28/1988 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/28/1988 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/07/1988 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 10/13/1987 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/13/1987 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/09/1987 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/09/1987 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |