Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019817
Company: BOEHRINGER INGELHEIM
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IV PERSANTINE DIPYRIDAMOLE 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No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
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.

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