Home Applications 020828 Application 020828
Type NDA
Sponsor HOFFMANN LA ROCHE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 FORTOVASE SAQUINAVIR CAPSULE;ORAL 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No
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date N020828-001 FORTOVASE SAQUINAVIR 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1997-11-07
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UTC 2022-10 N020828-001 FORTOVASE 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1997-11-07 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020828-001 FORTOVASE 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1997-11-07 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N020828-001 FORTOVASE 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1997-11-07 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N020828-001 FORTOVASE 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1997-11-07 a50c72e98297…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 N020828-001 6352717 2019-11-16 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020828-001 6352717*PED 2020-05-16 Pediatric extension 74a2ff9319b5…2020-12-22 03:56 UTC 2020-12 N020828-001 6352717*PED 2020-05-16 Pediatric extension 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020828-001 6352717*PED 2020-05-16 Pediatric extension c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020828-001 6352717 2019-11-16 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N020828-001 6352717*PED 2020-05-16 Pediatric extension 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020828-001 6352717 2019-11-16 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N020828-001 6352717*PED 2020-05-16 Pediatric extension b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020828-001 6352717 2019-11-16 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N020828-001 6352717*PED 2020-05-16 Pediatric extension ea99ee380514…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.