Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 012836
Company: BOEHRINGER INGELHEIM

Products on NDA 12836

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PERSANTINE	DIPYRIDAMOLE	25MG	TABLET;ORAL	Prescription	AB	Yes	No
PERSANTINE	DIPYRIDAMOLE	50MG	TABLET;ORAL	Prescription	AB	Yes	No
PERSANTINE	DIPYRIDAMOLE	75MG	TABLET;ORAL	Prescription	AB	Yes	Yes

Labels for NDA 012836

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/11/2019	SUPPL-61	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/012836s061lbl.pdf
08/01/2005	SUPPL-57	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/012836s057lbl.pdf