Home Applications 021814 Application 021814
Type NDA
Sponsor BOEHRINGER INGELHEIM Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 APTIVUS TIPRANAVIR CAPSULE;ORAL 250MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021814-001 APTIVUS TIPRANAVIR 250MG CAPSULE / ORAL RLD, RS 2005-06-22
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 N021814-001 APTIVUS 250MG CAPSULE / ORAL RLD, RS 2005-06-22 a50c72e98297…
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 5 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0597-0003 Aptivus tipranavir Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0003 Aptivus tipranavir Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0003 Aptivus tipranavir Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0003 Aptivus tipranavir Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0003 Aptivus tipranavir Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current