Drugs@FDA: FDA-Approved Drugs
Company: SHIRE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
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PRO-BANTHINE | PROPANTHELINE BROMIDE | 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
PRO-BANTHINE | PROPANTHELINE BROMIDE | 7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |
---|---|---|---|---|---|---|---|
04/02/1953 | 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 |
---|---|---|---|---|---|
02/17/1989 | SUPPL-34 | Labeling |
Label is not available on this site. |
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02/11/1988 | SUPPL-33 | Labeling |
Label is not available on this site. |
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02/11/1988 | SUPPL-32 | Labeling |
Label is not available on this site. |
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06/09/1983 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
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02/11/1988 | SUPPL-29 | Labeling |
Label is not available on this site. |
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04/06/1981 | SUPPL-28 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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03/18/1981 | SUPPL-26 | Labeling |
Label is not available on this site. |
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03/18/1981 | SUPPL-25 | Labeling |
Label is not available on this site. |
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03/18/1981 | SUPPL-24 | Labeling |
Label is not available on this site. |
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11/30/1979 | SUPPL-23 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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03/18/1981 | SUPPL-21 | Labeling |
Label is not available on this site. |