Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019817
Company: BOEHRINGER INGELHEIM

Products on NDA 019817

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
IV PERSANTINE	DIPYRIDAMOLE	5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	INJECTABLE;INJECTION	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019817

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/13/1990	ORIG-1	Approval	Type 3 - New Dosage Form	PRIORITY		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/20/2002	SUPPL-15	Manufacturing (CMC)-Control		Label is not available on this site.
02/08/2002	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
10/17/2000	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
03/22/2000	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
10/05/1999	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
05/15/1997	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
06/09/1995	SUPPL-8	Labeling		Label is not available on this site.
03/03/1995	SUPPL-7	Manufacturing (CMC)-Control		Label is not available on this site.
12/09/1994	SUPPL-5	Manufacturing (CMC)-Packaging		Label is not available on this site.
04/14/1993	SUPPL-4	Manufacturing (CMC)-Packaging		Label is not available on this site.
04/30/1991	SUPPL-3	Labeling		Label is not available on this site.
06/05/1991	SUPPL-2	Labeling		Label is not available on this site.
02/07/1991	SUPPL-1	Manufacturing (CMC)-Packaging		Label is not available on this site.