Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 007390
Company: SHIRE
Company: SHIRE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
BANTHINE | METHANTHELINE BROMIDE | 50MG | 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 |
---|---|---|---|---|---|---|---|
07/03/1951 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/02/1990 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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11/19/1987 | SUPPL-15 | Labeling |
Label is not available on this site. |
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02/02/1990 | SUPPL-14 | Labeling |
Label is not available on this site. |