Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 088440
Company: ODYSSEY PHARMS

Products on ANDA 088440

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
URECHOLINE	BETHANECHOL CHLORIDE	10MG	TABLET;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 088440

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				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/12/2002	SUPPL-16	Labeling		Label is not available on this site.
03/12/2002	SUPPL-15	Manufacturing (CMC)-Packaging		Label is not available on this site.
10/12/2001	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
10/25/2001	SUPPL-13	Manufacturing (CMC)-Control		Label is not available on this site.
10/25/2000	SUPPL-12	Manufacturing (CMC)-Manufacturing Process		Label is not available on this site.
10/02/2000	SUPPL-11	Manufacturing (CMC)-Facility		Label is not available on this site.
05/22/1996	SUPPL-10	Labeling		Label is not available on this site.
05/11/1994	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
05/14/1992	SUPPL-8	Labeling		Label is not available on this site.
02/28/1992	SUPPL-7	Labeling		Label is not available on this site.
03/25/1991	SUPPL-6	Labeling		Label is not available on this site.
07/08/1988	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.