Home Applications 214383 Application 214383
Type NDA
Sponsor ONCOPEPTIDES AB Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 PEPAXTO MELPHALAN FLUFENAMIDE INJECTABLE;INJECTION 20MG Yes No
Source provenance: Browse the complete Orange Book source catalog .
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 2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N214383-001 PEPAXTO EQ 20MG BASE/VIAL POWDER / INTRAVENOUS RLD 2021-02-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N214383-001 PEPAXTO EQ 20MG BASE/VIAL POWDER / INTRAVENOUS RLD 2021-02-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N214383-001 PEPAXTO EQ 20MG BASE/VIAL POWDER / INTRAVENOUS RLD 2021-02-26 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N214383-001 PEPAXTO EQ 20MG BASE/VIAL POWDER / INTRAVENOUS RLD 2021-02-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N214383-001 PEPAXTO EQ 20MG BASE/VIAL POWDER / INTRAVENOUS RLD 2021-02-26 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N214383-001 PEPAXTO EQ 20MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-26 87673890dc5c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N214383-001 PEPAXTO EQ 20MG BASE/VIAL POWDER / INTRAVENOUS RLD 2021-02-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N214383-001 PEPAXTO EQ 20MG BASE/VIAL POWDER / INTRAVENOUS RLD 2021-02-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N214383-001 PEPAXTO EQ 20MG BASE/VIAL POWDER / INTRAVENOUS RLD 2021-02-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N214383-001 PEPAXTO EQ 20MG BASE/VIAL POWDER / INTRAVENOUS RLD 2021-02-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N214383-001 PEPAXTO EQ 20MG BASE/VIAL POWDER / INTRAVENOUS RLD 2021-02-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N214383-001 PEPAXTO EQ 20MG BASE/VIAL POWDER / INTRAVENOUS RLD 2021-02-26 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N214383-001 PEPAXTO EQ 20MG BASE/VIAL POWDER / INTRAVENOUS RLD 2021-02-26 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N214383-001 PEPAXTO EQ 20MG BASE/VIAL POWDER / INTRAVENOUS RLD 2021-02-26 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N214383-001 PEPAXTO EQ 20MG BASE/VIAL POWDER / INTRAVENOUS RLD 2021-02-26 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N214383-001 PEPAXTO EQ 20MG BASE/VIAL POWDER / INTRAVENOUS RLD 2021-02-26 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N214383-001 PEPAXTO EQ 20MG BASE/VIAL POWDER / INTRAVENOUS RLD 2021-02-26 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N214383-001 PEPAXTO EQ 20MG BASE/VIAL POWDER / INTRAVENOUS RLD 2021-02-26 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N214383-001 PEPAXTO EQ 20MG BASE/VIAL POWDER / INTRAVENOUS RLD 2021-02-26 cb3db0bc1861…
Observed Orange Book patent history# Patent history page 1 of 3 · 108 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N214383-001 6992207 2022-06-25 U-3093 Drug substance, Drug product 2021-03-24 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N214383-001 10285946 2032-04-25 Drug product 2021-03-24 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N214383-001 10322182 2032-04-25 Drug product 2021-03-24 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N214383-001 10543274 2032-04-25 U-3093 2021-03-24 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N214383-001 10869928 2032-04-25 Drug product 2021-03-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N214383-001 6992207 2022-06-25 U-3093 Drug substance, Drug product 2021-03-24 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N214383-001 10285946 2032-04-25 Drug product 2021-03-24 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N214383-001 10322182 2032-04-25 Drug product 2021-03-24 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N214383-001 10543274 2032-04-25 U-3093 2021-03-24 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N214383-001 10869928 2032-04-25 Drug product 2021-03-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N214383-001 6992207 2022-06-25 U-3093 Drug substance, Drug product 2021-03-24 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N214383-001 10285946 2032-04-25 Drug product 2021-03-24 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N214383-001 10322182 2032-04-25 Drug product 2021-03-24 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N214383-001 10543274 2032-04-25 U-3093 2021-03-24 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N214383-001 10869928 2032-04-25 Drug product 2021-03-24 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N214383-001 6992207 2022-06-25 U-3093 Drug substance, Drug product 2021-03-24 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N214383-001 10285946 2032-04-25 Drug product 2021-03-24 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N214383-001 10322182 2032-04-25 Drug product 2021-03-24 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N214383-001 10543274 2032-04-25 U-3093 2021-03-24 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N214383-001 10869928 2032-04-25 Drug product 2021-03-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N214383-001 6992207 2022-06-25 U-3093 Drug substance, Drug product 2021-03-24 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N214383-001 10285946 2032-04-25 Drug product 2021-03-24 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N214383-001 10322182 2032-04-25 Drug product 2021-03-24 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N214383-001 10543274 2032-04-25 U-3093 2021-03-24 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N214383-001 10869928 2032-04-25 Drug product 2021-03-24 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N214383-001 6992207 2022-06-25 U-3093 Drug substance, Drug product 2021-03-24 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N214383-001 10285946 2032-04-25 Drug product 2021-03-24 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N214383-001 10322182 2032-04-25 Drug product 2021-03-24 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N214383-001 10543274 2032-04-25 U-3093 2021-03-24 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N214383-001 10869928 2032-04-25 Drug product 2021-03-24 87673890dc5c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N214383-001 6992207 2024-06-25 U-3093 Drug substance, Drug product 2021-03-24 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N214383-001 10285946 2032-04-25 Drug product 2021-03-24 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N214383-001 10322182 2032-04-25 Drug product 2021-03-24 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N214383-001 10543274 2032-04-25 U-3093 2021-03-24 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N214383-001 10869928 2032-04-25 Drug product 2021-03-24 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N214383-001 11344622 2032-04-25 U-3093 2022-06-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N214383-001 6992207 2024-06-25 U-3093 Drug substance, Drug product 2021-03-24 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 N214383-001 10285946 2032-04-25 Drug product 2021-03-24 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 N214383-001 10322182 2032-04-25 Drug product 2021-03-24 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 N214383-001 10543274 2032-04-25 U-3093 2021-03-24 1c564ffb4f44…
Observed Orange Book exclusivity history# NDC Listings For This Application# NDC listings for this application page 1 of 1 · 3 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 73657-020 Pepaxto melphalan flufenamide Oncopeptides, AB NDA Current 73657-020 Pepaxto melphalan flufenamide Oncopeptides, AB NDA Current 73657-020 Pepaxto melphalan flufenamide Oncopeptides, AB NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 66825 ORIG 2021-03-22 66417 ORIG 2021-03-01 66414 ORIG 2021-03-01