Drugs@FDA: FDA-Approved Drugs

New Drug Application (NDA): 006536
Company: ODYSSEY PHARMS

Products on NDA 006536

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URECHOLINE	BETHANECHOL CHLORIDE	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE;INJECTION	Discontinued	None	Yes	No
URECHOLINE	BETHANECHOL CHLORIDE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No
URECHOLINE	BETHANECHOL CHLORIDE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No
URECHOLINE	BETHANECHOL CHLORIDE	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No
URECHOLINE	BETHANECHOL CHLORIDE	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 006536

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	Note
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.