Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 088441
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.

03/12/2002 SUPPL-18 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/12/2001 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

10/25/2001 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

10/25/2000 SUPPL-15 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

10/02/2000 SUPPL-14 Manufacturing (CMC)-Facility

Label is not available on this site.

08/03/2000 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

02/24/2000 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

05/22/1996 SUPPL-11 Labeling

Label is not available on this site.

05/11/1994 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

05/14/1992 SUPPL-9 Labeling

Label is not available on this site.

02/28/1992 SUPPL-8 Labeling

Label is not available on this site.

03/25/1991 SUPPL-7 Labeling

Label is not available on this site.

08/01/1991 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

05/15/1986 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

06/30/1986 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

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