Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 072126
Company: PLIVA
Company: PLIVA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| METHYLDOPA | METHYLDOPA | 125MG | 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 |
|---|---|---|---|---|---|---|---|
| 07/07/1988 | 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 |
|---|---|---|---|---|---|
| 06/12/1998 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 06/10/1996 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 05/11/1994 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/05/1993 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 05/05/1993 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/05/1993 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/05/1993 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/22/1992 | SUPPL-4 | Labeling |
Label is not available on this site. |
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| 10/30/1990 | SUPPL-3 | Labeling |
Label is not available on this site. |
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| 06/26/1989 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |