Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021822
Company: BOEHRINGER INGELHEIM

• Summary Review

Products on NDA 021822

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
APTIVUS	TIPRANAVIR	100MG/ML	SOLUTION; ORAL	Prescription	None	TBD	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021822

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/23/2008	ORIG-1	Approval		PRIORITY	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021822LBL.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021822s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021822_aptivus_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021822s000Sumr.pdf

Labels for NDA 021822

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/23/2008	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021822LBL.pdf