Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 071279
Company: AM REGENT
Company: AM REGENT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
METHYLDOPATE HYDROCHLORIDE | METHYLDOPATE HYDROCHLORIDE | 50MG/ML | INJECTABLE;INJECTION | 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 |
---|---|---|---|---|---|---|---|
12/02/1987 | 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 |
---|---|---|---|---|---|
09/05/2001 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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06/16/1998 | SUPPL-10 | Labeling |
Label is not available on this site. |
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01/29/1998 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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09/13/1996 | SUPPL-8 | Labeling |
Label is not available on this site. |
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02/28/1996 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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06/20/1994 | SUPPL-6 | Labeling |
Label is not available on this site. |
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03/20/1995 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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03/16/1992 | SUPPL-4 | Labeling |
Label is not available on this site. |
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07/07/1990 | SUPPL-1 | Labeling |
Label is not available on this site. |