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 44 .
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.
Product history page 2 of 2 · 44 observed 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 2022-10-28 04:53 UTC 2022-10 N021814-001 APTIVUS 250MG CAPSULE / ORAL RLD, RS 2005-06-22 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021814-001 APTIVUS 250MG CAPSULE / ORAL RLD, RS 2005-06-22 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021814-001 APTIVUS 250MG CAPSULE / ORAL RLD, RS 2005-06-22 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N021814-001 APTIVUS 250MG CAPSULE / ORAL RLD, RS 2005-06-22 a50c72e98297…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2019-12-13 00:20 UTC 2019-12 N021814-001 6231887*PED 2019-01-27 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021814-001 5852195 2019-06-22 Drug substance 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021814-001 6147095 2019-10-29 U-670 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021814-001 5852195*PED 2019-12-22 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021814-001 6147095*PED 2020-04-29 Pediatric extension 74a2ff9319b5…2020-12-22 03:56 UTC 2020-12 N021814-001 6147095*PED 2020-04-29 Pediatric extension 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021814-001 6147095*PED 2020-04-29 Pediatric extension c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021814-001 6231887*PED 2019-01-27 Pediatric extension 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021814-001 5852195 2019-06-22 Drug substance 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021814-001 6147095 2019-10-29 U-670 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021814-001 5852195*PED 2019-12-22 Pediatric extension 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021814-001 6147095*PED 2020-04-29 Pediatric extension 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021814-001 6231887*PED 2019-01-27 Pediatric extension b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021814-001 5852195 2019-06-22 Drug substance b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021814-001 6147095 2019-10-29 U-670 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021814-001 5852195*PED 2019-12-22 Pediatric extension b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021814-001 6147095*PED 2020-04-29 Pediatric extension b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021814-001 6231887*PED 2019-01-27 Pediatric extension ea99ee380514…2019-07-19 19:46 UTC 2019-07 N021814-001 5852195 2019-06-22 Drug substance ea99ee380514…2019-07-19 19:46 UTC 2019-07 N021814-001 6147095 2019-10-29 U-670 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N021814-001 5852195*PED 2019-12-22 Pediatric extension ea99ee380514…2019-07-19 19:46 UTC 2019-07 N021814-001 6147095*PED 2020-04-29 Pediatric extension ea99ee380514…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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