Home Applications 202714 Application 202714
Type NDA
Sponsor ONYX THERAP Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 KYPROLIS CARFILZOMIB POWDER;INTRAVENOUS 60MG/VIAL Yes Yes 002 KYPROLIS CARFILZOMIB POWDER;INTRAVENOUS 30MG/VIAL Yes No 003 KYPROLIS CARFILZOMIB POWDER;INTRAVENOUS 10MG/VIAL Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N202714-001 KYPROLIS CARFILZOMIB 60MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2012-07-20 N202714-002 KYPROLIS CARFILZOMIB 30MG/VIAL POWDER / INTRAVENOUS RLD, RS 2016-06-03 N202714-003 KYPROLIS CARFILZOMIB 10MG/VIAL POWDER / INTRAVENOUS RLD, RS 2018-06-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N202714-001 AP
Orange Book patents# Current patent rows page 1 of 1 · 30 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N202714-001 7417042 2026-07-20 Drug substance, Drug product 2012-08-09 N202714-001 7417042*PED 2027-01-20 Pediatric extension N202714-001 7737112 2027-12-07 Drug product 2012-08-09 N202714-001 7737112*PED 2028-06-07 Pediatric extension N202714-001 RE47954 2029-10-21 U-3449 2022-10-18 N202714-001 RE47954*PED 2030-04-21 Pediatric extension N202714-001 9493582 2033-02-27 Drug product 2017-03-09 N202714-001 9493582*PED 2033-08-27 Pediatric extension N202714-001 12636340 2041-04-29 U-4551 2026-06-23 N202714-001 12636340*PED 2041-10-29 Pediatric extension N202714-002 7417042 2026-07-20 Drug substance, Drug product 2016-08-15 N202714-002 7417042*PED 2027-01-20 Pediatric extension N202714-002 7737112 2027-12-07 Drug product 2016-08-15 N202714-002 7737112*PED 2028-06-07 Pediatric extension N202714-002 RE47954 2029-10-21 U-3449 2022-10-18 N202714-002 RE47954*PED 2030-04-21 Pediatric extension N202714-002 9493582 2033-02-27 Drug product 2017-03-09 N202714-002 9493582*PED 2033-08-27 Pediatric extension N202714-002 12636340 2041-04-29 U-4551 2026-06-23 N202714-002 12636340*PED 2041-10-29 Pediatric extension N202714-003 7417042 2026-07-20 Drug substance, Drug product 2018-06-20 N202714-003 7417042*PED 2027-01-20 Pediatric extension N202714-003 7737112 2027-12-07 Drug product 2018-06-20 N202714-003 7737112*PED 2028-06-07 Pediatric extension N202714-003 RE47954 2029-10-21 U-3449 2022-10-18 N202714-003 RE47954*PED 2030-04-21 Pediatric extension N202714-003 9493582 2033-02-27 Drug product 2018-06-20 N202714-003 9493582*PED 2033-08-27 Pediatric extension N202714-003 12636340 2041-04-29 U-4551 2026-06-23 N202714-003 12636340*PED 2041-10-29 Pediatric extension
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 6 matching rows.
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 N202714-001 KYPROLIS 60MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2012-07-20 a50c72e98297…2026-08-01 22:54:32 2026-06 N202714-002 KYPROLIS 30MG/VIAL POWDER / INTRAVENOUS RLD, RS 2016-06-03 a50c72e98297…2026-08-01 22:54:32 2026-06 N202714-003 KYPROLIS 10MG/VIAL POWDER / INTRAVENOUS RLD, RS 2018-06-07 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 N202714-001 AP 1 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 2026-08-01 22:54:32 2026-06 N202714-001 7417042 2026-07-20 Drug substance, Drug product 2012-08-09 a50c72e98297…2026-08-01 22:54:32 2026-06 N202714-001 7417042*PED 2027-01-20 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N202714-001 7737112 2027-12-07 Drug product 2012-08-09 a50c72e98297…2026-08-01 22:54:32 2026-06 N202714-001 7737112*PED 2028-06-07 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N202714-001 RE47954 2029-10-21 U-3449 2022-10-18 a50c72e98297…2026-08-01 22:54:32 2026-06 N202714-001 RE47954*PED 2030-04-21 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N202714-001 9493582 2033-02-27 Drug product 2017-03-09 a50c72e98297…2026-08-01 22:54:32 2026-06 N202714-001 9493582*PED 2033-08-27 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N202714-001 12636340 2041-04-29 U-4551 2026-06-23 a50c72e98297…2026-08-01 22:54:32 2026-06 N202714-001 12636340*PED 2041-10-29 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N202714-002 7417042 2026-07-20 Drug substance, Drug product 2016-08-15 a50c72e98297…2026-08-01 22:54:32 2026-06 N202714-002 7417042*PED 2027-01-20 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N202714-002 7737112 2027-12-07 Drug product 2016-08-15 a50c72e98297…2026-08-01 22:54:32 2026-06 N202714-002 7737112*PED 2028-06-07 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N202714-002 RE47954 2029-10-21 U-3449 2022-10-18 a50c72e98297…2026-08-01 22:54:32 2026-06 N202714-002 RE47954*PED 2030-04-21 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N202714-002 9493582 2033-02-27 Drug product 2017-03-09 a50c72e98297…2026-08-01 22:54:32 2026-06 N202714-002 9493582*PED 2033-08-27 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N202714-002 12636340 2041-04-29 U-4551 2026-06-23 a50c72e98297…2026-08-01 22:54:32 2026-06 N202714-002 12636340*PED 2041-10-29 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N202714-003 7417042 2026-07-20 Drug substance, Drug product 2018-06-20 a50c72e98297…2026-08-01 22:54:32 2026-06 N202714-003 7417042*PED 2027-01-20 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N202714-003 7737112 2027-12-07 Drug product 2018-06-20 a50c72e98297…2026-08-01 22:54:32 2026-06 N202714-003 7737112*PED 2028-06-07 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N202714-003 RE47954 2029-10-21 U-3449 2022-10-18 a50c72e98297…2026-08-01 22:54:32 2026-06 N202714-003 RE47954*PED 2030-04-21 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N202714-003 9493582 2033-02-27 Drug product 2018-06-20 a50c72e98297…2026-08-01 22:54:32 2026-06 N202714-003 9493582*PED 2033-08-27 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N202714-003 12636340 2041-04-29 U-4551 2026-06-23 a50c72e98297…2026-08-01 22:54:32 2026-06 N202714-003 12636340*PED 2041-10-29 Pediatric extension a50c72e98297…
Observed Orange Book exclusivity history# openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 33 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 76075-101 KYPROLIS carfilzomib Onyx Pharmaceuticals, Inc. NDA Current 76075-101 KYPROLIS carfilzomib Onyx Pharmaceuticals, Inc. NDA Current 76075-101 KYPROLIS carfilzomib Onyx Pharmaceuticals, Inc. NDA Current 76075-101 KYPROLIS carfilzomib Onyx Pharmaceuticals, Inc. NDA Current 76075-101 KYPROLIS carfilzomib Onyx Pharmaceuticals, Inc. NDA Current 76075-101 KYPROLIS carfilzomib Onyx Pharmaceuticals, Inc. NDA Current 76075-101 KYPROLIS carfilzomib Onyx Pharmaceuticals, Inc. NDA Current 76075-101 KYPROLIS carfilzomib Onyx Pharmaceuticals, Inc. NDA Current 76075-101 KYPROLIS carfilzomib Onyx Pharmaceuticals, Inc. NDA Current 76075-101 KYPROLIS carfilzomib Onyx Pharmaceuticals, Inc. NDA Current 76075-101 KYPROLIS carfilzomib Onyx Pharmaceuticals, Inc. NDA Current 76075-102 KYPROLIS carfilzomib Onyx Pharmaceuticals, Inc. NDA Current 76075-102 KYPROLIS carfilzomib Onyx Pharmaceuticals, Inc. NDA Current 76075-102 KYPROLIS carfilzomib Onyx Pharmaceuticals, Inc. NDA Current 76075-102 KYPROLIS carfilzomib Onyx Pharmaceuticals, Inc. NDA Current 76075-102 KYPROLIS carfilzomib Onyx Pharmaceuticals, Inc. NDA Current 76075-102 KYPROLIS carfilzomib Onyx Pharmaceuticals, Inc. NDA Current 76075-102 KYPROLIS carfilzomib Onyx Pharmaceuticals, Inc. NDA Current 76075-102 KYPROLIS carfilzomib Onyx Pharmaceuticals, Inc. NDA Current 76075-102 KYPROLIS carfilzomib Onyx Pharmaceuticals, Inc. NDA Current 76075-102 KYPROLIS carfilzomib Onyx Pharmaceuticals, Inc. NDA Current 76075-102 KYPROLIS carfilzomib Onyx Pharmaceuticals, Inc. NDA Current 76075-103 KYPROLIS carfilzomib Onyx Pharmaceuticals, Inc. NDA Current 76075-103 KYPROLIS carfilzomib Onyx Pharmaceuticals, Inc. NDA Current 76075-103 KYPROLIS carfilzomib Onyx Pharmaceuticals, Inc. NDA Current 76075-103 KYPROLIS carfilzomib Onyx Pharmaceuticals, Inc. NDA Current 76075-103 KYPROLIS carfilzomib Onyx Pharmaceuticals, Inc. NDA Current 76075-103 KYPROLIS carfilzomib Onyx Pharmaceuticals, Inc. NDA Current 76075-103 KYPROLIS carfilzomib Onyx Pharmaceuticals, Inc. NDA Current 76075-103 KYPROLIS carfilzomib Onyx Pharmaceuticals, Inc. NDA Current 76075-103 KYPROLIS carfilzomib Onyx Pharmaceuticals, Inc. NDA Current 76075-103 KYPROLIS carfilzomib Onyx Pharmaceuticals, Inc. NDA Current 76075-103 KYPROLIS carfilzomib Onyx Pharmaceuticals, Inc. NDA Current