Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 008732
Company: SHIRE

Products on NDA 008732

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PRO-BANTHINE	PROPANTHELINE BROMIDE	15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	Yes	No
PRO-BANTHINE	PROPANTHELINE BROMIDE	7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	Yes	No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 008732

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/02/1953	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/17/1989	SUPPL-34	Labeling		Label is not available on this site.
02/11/1988	SUPPL-33	Labeling		Label is not available on this site.
02/11/1988	SUPPL-32	Labeling		Label is not available on this site.
06/09/1983	SUPPL-31	Manufacturing (CMC)		Label is not available on this site.
02/11/1988	SUPPL-29	Labeling		Label is not available on this site.
04/06/1981	SUPPL-28	Manufacturing (CMC)-Packaging		Label is not available on this site.
03/18/1981	SUPPL-26	Labeling		Label is not available on this site.
03/18/1981	SUPPL-25	Labeling		Label is not available on this site.
03/18/1981	SUPPL-24	Labeling		Label is not available on this site.
11/30/1979	SUPPL-23	Manufacturing (CMC)-Formulation		Label is not available on this site.
03/18/1981	SUPPL-21	Labeling		Label is not available on this site.