Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 006536
Company: ODYSSEY PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
URECHOLINE BETHANECHOL CHLORIDE 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No
URECHOLINE BETHANECHOL CHLORIDE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
URECHOLINE BETHANECHOL CHLORIDE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
URECHOLINE BETHANECHOL CHLORIDE 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
URECHOLINE BETHANECHOL CHLORIDE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No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
10/12/1948 ORIG-1 Approval UNKNOWN

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/20/1998 SUPPL-43 Manufacturing (CMC)-Control

Label is not available on this site.

03/31/1998 SUPPL-42 Manufacturing (CMC)-Control

Label is not available on this site.

08/14/1997 SUPPL-41 Manufacturing (CMC)-Control

Label is not available on this site.

09/03/1996 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

03/11/1996 SUPPL-39 Manufacturing (CMC)-Control

Label is not available on this site.

04/02/1998 SUPPL-38 Labeling

Label is not available on this site.

09/11/1995 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

08/09/1993 SUPPL-36 Labeling

Label is not available on this site.

08/28/1992 SUPPL-35 Manufacturing (CMC)-Control

Label is not available on this site.

03/09/1987 SUPPL-34 Labeling

Label is not available on this site.

09/12/1985 SUPPL-33 Manufacturing (CMC)-Control

Label is not available on this site.

07/03/1985 SUPPL-32 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/11/1984 SUPPL-31 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/24/1984 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

09/16/1983 SUPPL-29 Manufacturing (CMC)-Formulation

Label is not available on this site.

01/14/1985 SUPPL-28 Labeling

Label is not available on this site.

07/14/1981 SUPPL-27 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/03/1981 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

06/17/1981 SUPPL-25 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/22/1980 SUPPL-24 Manufacturing (CMC)-Formulation

Label is not available on this site.

05/01/1980 SUPPL-23 Labeling

Label is not available on this site.

05/29/1980 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

06/24/1980 SUPPL-21 Labeling

Label is not available on this site.

08/13/1979 SUPPL-20 Labeling

Label is not available on this site.

05/01/1980 SUPPL-18 Labeling

Label is not available on this site.

05/01/1980 SUPPL-17 Labeling

Label is not available on this site.

10/02/1978 SUPPL-16 Labeling

Label is not available on this site.

12/12/1977 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

09/19/1977 SUPPL-14 Labeling

Label is not available on this site.

05/17/1976 SUPPL-13 Labeling

Label is not available on this site.

05/17/1976 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

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