Home Applications 021462 Application 021462
Type NDA
Sponsor LILLY Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ALIMTA PEMETREXED DISODIUM POWDER;INTRAVENOUS EQ 500MG BASE/VIAL Yes Yes 002 ALIMTA PEMETREXED DISODIUM POWDER;INTRAVENOUS EQ 100MG BASE/VIAL Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021462-001 ALIMTA PEMETREXED DISODIUM EQ 500MG BASE/VIAL POWDER / INTRAVENOUS AP RLD, RS 2004-02-04 N021462-002 ALIMTA PEMETREXED DISODIUM EQ 100MG BASE/VIAL POWDER / INTRAVENOUS AP RLD, RS 2007-09-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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.
Product history page 1 of 3 · 84 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 2026-08-18 06:07:40 2026-07 N021462-001 ALIMTA EQ 500MG BASE/VIAL POWDER / INTRAVENOUS AP RLD, RS 2004-02-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021462-002 ALIMTA EQ 100MG BASE/VIAL POWDER / INTRAVENOUS AP RLD, RS 2007-09-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021462-001 ALIMTA EQ 500MG BASE/VIAL POWDER / INTRAVENOUS AP RLD, RS 2004-02-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021462-002 ALIMTA EQ 100MG BASE/VIAL POWDER / INTRAVENOUS AP RLD, RS 2007-09-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021462-001 ALIMTA EQ 500MG BASE/VIAL POWDER / INTRAVENOUS AP RLD, RS 2004-02-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021462-002 ALIMTA EQ 100MG BASE/VIAL POWDER / INTRAVENOUS AP RLD, RS 2007-09-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021462-001 ALIMTA EQ 500MG BASE/VIAL POWDER / INTRAVENOUS AP RLD, RS 2004-02-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021462-002 ALIMTA EQ 100MG BASE/VIAL POWDER / INTRAVENOUS AP RLD, RS 2007-09-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021462-001 ALIMTA EQ 500MG BASE/VIAL POWDER / INTRAVENOUS AP RLD, RS 2004-02-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021462-002 ALIMTA EQ 100MG BASE/VIAL POWDER / INTRAVENOUS AP RLD, RS 2007-09-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021462-001 ALIMTA EQ 500MG BASE/VIAL POWDER / INTRAVENOUS AP RLD, RS 2004-02-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021462-002 ALIMTA EQ 100MG BASE/VIAL POWDER / INTRAVENOUS AP RLD, RS 2007-09-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021462-001 ALIMTA EQ 500MG BASE/VIAL POWDER / INTRAVENOUS AP RLD, RS 2004-02-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021462-002 ALIMTA EQ 100MG BASE/VIAL POWDER / INTRAVENOUS AP RLD, RS 2007-09-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021462-001 ALIMTA EQ 500MG BASE/VIAL POWDER / INTRAVENOUS AP RLD, RS 2004-02-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021462-002 ALIMTA EQ 100MG BASE/VIAL POWDER / INTRAVENOUS AP RLD, RS 2007-09-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021462-001 ALIMTA EQ 500MG BASE/VIAL POWDER / INTRAVENOUS AP RLD, RS 2004-02-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021462-002 ALIMTA EQ 100MG BASE/VIAL POWDER / INTRAVENOUS AP RLD, RS 2007-09-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021462-001 ALIMTA EQ 500MG BASE/VIAL POWDER / INTRAVENOUS AP RLD, RS 2004-02-04 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021462-002 ALIMTA EQ 100MG BASE/VIAL POWDER / INTRAVENOUS AP RLD, RS 2007-09-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021462-001 ALIMTA EQ 500MG BASE/VIAL POWDER / INTRAVENOUS AP RLD, RS 2004-02-04 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021462-002 ALIMTA EQ 100MG BASE/VIAL POWDER / INTRAVENOUS AP RLD, RS 2007-09-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021462-001 ALIMTA EQ 500MG BASE/VIAL POWDER / INTRAVENOUS AP RLD, RS 2004-02-04 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021462-002 ALIMTA EQ 100MG BASE/VIAL POWDER / INTRAVENOUS AP RLD, RS 2007-09-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021462-001 ALIMTA EQ 500MG BASE/VIAL POWDER / INTRAVENOUS AP RLD, RS 2004-02-04 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021462-002 ALIMTA EQ 100MG BASE/VIAL POWDER / INTRAVENOUS AP RLD, RS 2007-09-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021462-001 ALIMTA EQ 500MG BASE/VIAL POWDER / INTRAVENOUS AP RLD, RS 2004-02-04 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021462-002 ALIMTA EQ 100MG BASE/VIAL POWDER / INTRAVENOUS AP RLD, RS 2007-09-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021462-001 ALIMTA EQ 500MG BASE/VIAL POWDER / INTRAVENOUS AP RLD, RS 2004-02-04 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N021462-002 ALIMTA EQ 100MG BASE/VIAL POWDER / INTRAVENOUS AP RLD, RS 2007-09-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021462-001 ALIMTA EQ 500MG BASE/VIAL POWDER / INTRAVENOUS AP RLD, RS 2004-02-04 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021462-002 ALIMTA EQ 100MG BASE/VIAL POWDER / INTRAVENOUS AP RLD, RS 2007-09-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021462-001 ALIMTA EQ 500MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2004-02-04 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021462-002 ALIMTA EQ 100MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2007-09-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021462-001 ALIMTA EQ 500MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2004-02-04 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021462-002 ALIMTA EQ 100MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2007-09-07 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021462-001 ALIMTA EQ 500MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2004-02-04 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021462-002 ALIMTA EQ 100MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2007-09-07 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021462-001 ALIMTA EQ 500MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2004-02-04 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021462-002 ALIMTA EQ 100MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2007-09-07 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 60 observed states.
Observed Orange Book patent history# Patent history page 1 of 2 · 54 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 N021462-001 7772209*PED 2022-05-24 Pediatric extension 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021462-002 7772209*PED 2022-05-24 Pediatric extension 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021462-001 7772209*PED 2022-05-24 Pediatric extension 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021462-002 7772209*PED 2022-05-24 Pediatric extension 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021462-001 7772209*PED 2022-05-24 Pediatric extension 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021462-002 7772209*PED 2022-05-24 Pediatric extension 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021462-001 7772209 2021-11-24 U-1296 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021462-001 7772209*PED 2022-05-24 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021462-002 7772209 2021-11-24 U-1296 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021462-002 7772209*PED 2022-05-24 Pediatric extension 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021462-001 7772209*PED 2022-05-24 Pediatric extension bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021462-002 7772209*PED 2022-05-24 Pediatric extension bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021462-001 7772209 2021-11-24 U-1296 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021462-001 7772209*PED 2022-05-24 Pediatric extension 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021462-002 7772209 2021-11-24 U-1296 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021462-002 7772209*PED 2022-05-24 Pediatric extension 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021462-001 7772209 2021-11-24 U-1296 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021462-001 7772209*PED 2022-05-24 Pediatric extension 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021462-002 7772209 2021-11-24 U-1296 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021462-002 7772209*PED 2022-05-24 Pediatric extension 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021462-001 7772209 2021-11-24 U-1296 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N021462-001 7772209*PED 2022-05-24 Pediatric extension 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N021462-002 7772209 2021-11-24 U-1296 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N021462-002 7772209*PED 2022-05-24 Pediatric extension 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021462-001 7772209 2021-11-24 U-1296 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021462-001 7772209*PED 2022-05-24 Pediatric extension 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021462-002 7772209 2021-11-24 U-1296 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021462-002 7772209*PED 2022-05-24 Pediatric extension 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021462-001 7772209 2021-11-24 U-1296 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021462-001 7772209*PED 2022-05-24 Pediatric extension c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021462-002 7772209 2021-11-24 U-1296 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021462-002 7772209*PED 2022-05-24 Pediatric extension c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021462-001 7772209 2021-11-24 U-1296 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021462-001 7772209*PED 2022-05-24 Pediatric extension 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021462-002 7772209 2021-11-24 U-1296 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021462-002 7772209*PED 2022-05-24 Pediatric extension 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021462-001 7772209 2021-11-24 U-1296 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021462-001 7772209*PED 2022-05-24 Pediatric extension b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021462-002 7772209 2021-11-24 U-1296 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021462-002 7772209*PED 2022-05-24 Pediatric extension b00525d2431f…
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown 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 · 10 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0002-7623 Alimta Pemetrexed disodium Eli Lilly and Company NDA Current 0002-7623 Alimta Pemetrexed disodium Eli Lilly and Company NDA Current 0002-7623 Alimta Pemetrexed disodium Eli Lilly and Company NDA Current 0002-7623 Alimta Pemetrexed disodium Eli Lilly and Company NDA Current 0002-7623 Alimta Pemetrexed disodium Eli Lilly and Company NDA Current 0002-7640 Alimta Pemetrexed disodium Eli Lilly and Company NDA Current 0002-7640 Alimta Pemetrexed disodium Eli Lilly and Company NDA Current 0002-7640 Alimta Pemetrexed disodium Eli Lilly and Company NDA Current 0002-7640 Alimta Pemetrexed disodium Eli Lilly and Company NDA Current 0002-7640 Alimta Pemetrexed disodium Eli Lilly and Company NDA Current