Drugs@FDA: FDA-Approved Drugs
Company: SUN PHARM INDUSTRIES
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 |
---|---|---|---|---|---|---|---|
10/09/1986 | 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 |
---|---|---|---|---|---|
08/05/1998 | SUPPL-23 | Labeling |
Label is not available on this site. |
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12/01/1998 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
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10/11/1996 | SUPPL-21 | Labeling |
Label is not available on this site. |
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12/23/1994 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
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10/11/1994 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
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04/21/1993 | SUPPL-18 | Labeling |
Label is not available on this site. |
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04/03/1992 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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04/03/1992 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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05/06/1991 | SUPPL-14 | Labeling |
Label is not available on this site. |
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11/06/1989 | SUPPL-12 | Bioequivalence |
Label is not available on this site. |
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04/25/1989 | SUPPL-10 | Labeling |
Label is not available on this site. |
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01/25/1989 | SUPPL-9 | Labeling |
Label is not available on this site. |
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01/11/1989 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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01/21/1988 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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03/31/1987 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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01/21/1988 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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01/21/1988 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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01/21/1988 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |