Drugs@FDA: FDA-Approved Drugs
Company: ODYSSEY PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
URECHOLINE | BETHANECHOL CHLORIDE | 25MG | 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 |
---|---|---|---|---|---|---|---|
05/29/1984 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/088441.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/12/2002 | SUPPL-19 | Labeling |
Label is not available on this site. |
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03/12/2002 | SUPPL-18 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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10/12/2001 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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10/25/2001 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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10/25/2000 | SUPPL-15 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
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10/02/2000 | SUPPL-14 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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08/03/2000 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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02/24/2000 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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05/22/1996 | SUPPL-11 | Labeling |
Label is not available on this site. |
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05/11/1994 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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05/14/1992 | SUPPL-9 | Labeling |
Label is not available on this site. |
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02/28/1992 | SUPPL-8 | Labeling |
Label is not available on this site. |
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03/25/1991 | SUPPL-7 | Labeling |
Label is not available on this site. |
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08/01/1991 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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05/15/1986 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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06/30/1986 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |