Application 021462

Type
NDA
Sponsor
LILLY

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ALIMTAPEMETREXED DISODIUMPOWDER;INTRAVENOUSEQ 500MG BASE/VIALYesYes
002ALIMTAPEMETREXED DISODIUMPOWDER;INTRAVENOUSEQ 100MG BASE/VIALYesYes

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021462-001ALIMTAPEMETREXED DISODIUMEQ 500MG BASE/VIALPOWDER / INTRAVENOUSAPRLD, RS2004-02-04
N021462-002ALIMTAPEMETREXED DISODIUMEQ 100MG BASE/VIALPOWDER / INTRAVENOUSAPRLD, RS2007-09-07

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
N021462-001AP
N021462-002AP

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N021462-001ALIMTAEQ 500MG BASE/VIALPOWDER / INTRAVENOUSAPRLD, RS2004-02-04caaa826d4ba7…
2026-08-18 06:07:402026-07N021462-002ALIMTAEQ 100MG BASE/VIALPOWDER / INTRAVENOUSAPRLD, RS2007-09-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021462-001ALIMTAEQ 500MG BASE/VIALPOWDER / INTRAVENOUSAPRLD, RS2004-02-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021462-002ALIMTAEQ 100MG BASE/VIALPOWDER / INTRAVENOUSAPRLD, RS2007-09-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021462-001ALIMTAEQ 500MG BASE/VIALPOWDER / INTRAVENOUSAPRLD, RS2004-02-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021462-002ALIMTAEQ 100MG BASE/VIALPOWDER / INTRAVENOUSAPRLD, RS2007-09-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08N021462-001ALIMTAEQ 500MG BASE/VIALPOWDER / INTRAVENOUSAPRLD, RS2004-02-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021462-002ALIMTAEQ 100MG BASE/VIALPOWDER / INTRAVENOUSAPRLD, RS2007-09-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021462-001ALIMTAEQ 500MG BASE/VIALPOWDER / INTRAVENOUSAPRLD, RS2004-02-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021462-002ALIMTAEQ 100MG BASE/VIALPOWDER / INTRAVENOUSAPRLD, RS2007-09-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021462-001ALIMTAEQ 500MG BASE/VIALPOWDER / INTRAVENOUSAPRLD, RS2004-02-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021462-002ALIMTAEQ 100MG BASE/VIALPOWDER / INTRAVENOUSAPRLD, RS2007-09-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021462-001ALIMTAEQ 500MG BASE/VIALPOWDER / INTRAVENOUSAPRLD, RS2004-02-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021462-002ALIMTAEQ 100MG BASE/VIALPOWDER / INTRAVENOUSAPRLD, RS2007-09-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021462-001ALIMTAEQ 500MG BASE/VIALPOWDER / INTRAVENOUSAPRLD, RS2004-02-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021462-002ALIMTAEQ 100MG BASE/VIALPOWDER / INTRAVENOUSAPRLD, RS2007-09-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021462-001ALIMTAEQ 500MG BASE/VIALPOWDER / INTRAVENOUSAPRLD, RS2004-02-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021462-002ALIMTAEQ 100MG BASE/VIALPOWDER / INTRAVENOUSAPRLD, RS2007-09-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021462-001ALIMTAEQ 500MG BASE/VIALPOWDER / INTRAVENOUSAPRLD, RS2004-02-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021462-002ALIMTAEQ 100MG BASE/VIALPOWDER / INTRAVENOUSAPRLD, RS2007-09-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021462-001ALIMTAEQ 500MG BASE/VIALPOWDER / INTRAVENOUSAPRLD, RS2004-02-04d06236e962d9…
2024-10-29 15:01 UTC2024-10N021462-002ALIMTAEQ 100MG BASE/VIALPOWDER / INTRAVENOUSAPRLD, RS2007-09-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021462-001ALIMTAEQ 500MG BASE/VIALPOWDER / INTRAVENOUSAPRLD, RS2004-02-0479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021462-002ALIMTAEQ 100MG BASE/VIALPOWDER / INTRAVENOUSAPRLD, RS2007-09-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021462-001ALIMTAEQ 500MG BASE/VIALPOWDER / INTRAVENOUSAPRLD, RS2004-02-04301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021462-002ALIMTAEQ 100MG BASE/VIALPOWDER / INTRAVENOUSAPRLD, RS2007-09-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021462-001ALIMTAEQ 500MG BASE/VIALPOWDER / INTRAVENOUSAPRLD, RS2004-02-041e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021462-002ALIMTAEQ 100MG BASE/VIALPOWDER / INTRAVENOUSAPRLD, RS2007-09-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021462-001ALIMTAEQ 500MG BASE/VIALPOWDER / INTRAVENOUSAPRLD, RS2004-02-048072bd15b7f6…
2024-05-31 18:47 UTC2024-05N021462-002ALIMTAEQ 100MG BASE/VIALPOWDER / INTRAVENOUSAPRLD, RS2007-09-078072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021462-001ALIMTAEQ 500MG BASE/VIALPOWDER / INTRAVENOUSAPRLD, RS2004-02-045c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021462-002ALIMTAEQ 100MG BASE/VIALPOWDER / INTRAVENOUSAPRLD, RS2007-09-075c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021462-001ALIMTAEQ 500MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2004-02-045d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021462-002ALIMTAEQ 100MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2007-09-075d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021462-001ALIMTAEQ 500MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2004-02-044b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021462-002ALIMTAEQ 100MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2007-09-074b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021462-001ALIMTAEQ 500MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2004-02-0474a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021462-002ALIMTAEQ 100MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2007-09-0774a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021462-001ALIMTAEQ 500MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2004-02-04bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021462-002ALIMTAEQ 100MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2007-09-07bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 60 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07N021462-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07N021462-002AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021462-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021462-002AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021462-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021462-002AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08N021462-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021462-002AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021462-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021462-002AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021462-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021462-002AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021462-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021462-002AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021462-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021462-002AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021462-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021462-002AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021462-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021462-002AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021462-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10N021462-002AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021462-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021462-002AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021462-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021462-002AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021462-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021462-002AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021462-001AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N021462-002AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021462-001AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021462-002AP15c6f7cd8ea54…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021462-001AP16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021462-002AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021462-001AP11c564ffb4f44…
2024-02-18 07:12 UTC2024-02N021462-002AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021462-001AP1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12N021462-002AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021462-001AP1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021462-002AP1a72a2bbeb626…

Observed Orange Book patent history#

Patent history page 1 of 2 · 54 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021462-0017772209*PED2022-05-24Pediatric extension5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021462-0027772209*PED2022-05-24Pediatric extension5c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021462-0017772209*PED2022-05-24Pediatric extension5d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021462-0027772209*PED2022-05-24Pediatric extension5d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021462-0017772209*PED2022-05-24Pediatric extension4b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021462-0027772209*PED2022-05-24Pediatric extension4b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021462-00177722092021-11-24U-129674a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021462-0017772209*PED2022-05-24Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021462-00277722092021-11-24U-129674a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021462-0027772209*PED2022-05-24Pediatric extension74a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021462-0017772209*PED2022-05-24Pediatric extensionbb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021462-0027772209*PED2022-05-24Pediatric extensionbb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021462-00177722092021-11-24U-1296782e0a99824c…
2021-12-28 21:50 UTC2021-12N021462-0017772209*PED2022-05-24Pediatric extension782e0a99824c…
2021-12-28 21:50 UTC2021-12N021462-00277722092021-11-24U-1296782e0a99824c…
2021-12-28 21:50 UTC2021-12N021462-0027772209*PED2022-05-24Pediatric extension782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021462-00177722092021-11-24U-129687673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021462-0017772209*PED2022-05-24Pediatric extension87673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021462-00277722092021-11-24U-129687673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021462-0027772209*PED2022-05-24Pediatric extension87673890dc5c…
2021-03-12 10:30 UTC2021-03N021462-00177722092021-11-24U-12965aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021462-0017772209*PED2022-05-24Pediatric extension5aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021462-00277722092021-11-24U-12965aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021462-0027772209*PED2022-05-24Pediatric extension5aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021462-00177722092021-11-24U-12968869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021462-0017772209*PED2022-05-24Pediatric extension8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021462-00277722092021-11-24U-12968869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021462-0027772209*PED2022-05-24Pediatric extension8869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021462-00177722092021-11-24U-1296c0c555d07b60…
2020-11-12 02:37 UTC2020-11N021462-0017772209*PED2022-05-24Pediatric extensionc0c555d07b60…
2020-11-12 02:37 UTC2020-11N021462-00277722092021-11-24U-1296c0c555d07b60…
2020-11-12 02:37 UTC2020-11N021462-0027772209*PED2022-05-24Pediatric extensionc0c555d07b60…
2019-12-14 00:12 UTC2019-12N021462-00177722092021-11-24U-12963f01610625f2…
2019-12-14 00:12 UTC2019-12N021462-0017772209*PED2022-05-24Pediatric extension3f01610625f2…
2019-12-14 00:12 UTC2019-12N021462-00277722092021-11-24U-12963f01610625f2…
2019-12-14 00:12 UTC2019-12N021462-0027772209*PED2022-05-24Pediatric extension3f01610625f2…
2019-09-15 20:21 UTC2019-09N021462-00177722092021-11-24U-1296b00525d2431f…
2019-09-15 20:21 UTC2019-09N021462-0017772209*PED2022-05-24Pediatric extensionb00525d2431f…
2019-09-15 20:21 UTC2019-09N021462-00277722092021-11-24U-1296b00525d2431f…
2019-09-15 20:21 UTC2019-09N021462-0027772209*PED2022-05-24Pediatric extensionb00525d2431f…

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AlimtaPEMETREXED DISODIUMEli Lilly and Companyf5a860f3-37ec-429c-ae04-9c88d7c55c082023-05-19Warnings, Adverse reactionsExact identifier
application applno (NDA): 021462
application number: NDA021462
ndc (product): 0002-7640
ndc (product): 0002-7623

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0002-7623AlimtaPemetrexed disodiumEli Lilly and CompanyNDACurrent
0002-7623AlimtaPemetrexed disodiumEli Lilly and CompanyNDACurrent
0002-7623AlimtaPemetrexed disodiumEli Lilly and CompanyNDACurrent
0002-7623AlimtaPemetrexed disodiumEli Lilly and CompanyNDACurrent
0002-7623AlimtaPemetrexed disodiumEli Lilly and CompanyNDACurrent
0002-7640AlimtaPemetrexed disodiumEli Lilly and CompanyNDACurrent
0002-7640AlimtaPemetrexed disodiumEli Lilly and CompanyNDACurrent
0002-7640AlimtaPemetrexed disodiumEli Lilly and CompanyNDACurrent
0002-7640AlimtaPemetrexed disodiumEli Lilly and CompanyNDACurrent
0002-7640AlimtaPemetrexed disodiumEli Lilly and CompanyNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
71992SUPPL2022-09-01
71987SUPPL2022-09-01
65711SUPPL2020-12-23
57520SUPPL2019-02-13
57393SUPPL2019-01-31
54438SUPPL2018-06-05
54436SUPPL2018-06-05
53756SUPPL2018-04-20
50020SUPPL2017-10-12
50019SUPPL2017-10-12
15534SUPPL2013-09-17
5456SUPPL2013-09-13
37004SUPPL2013-01-22
37005SUPPL2012-11-15
27862SUPPL2012-11-14
5455SUPPL2012-10-18
15532SUPPL2012-10-17
27861SUPPL2012-06-07
15533SUPPL2012-06-05
37002SUPPL2011-11-25
15531SUPPL2011-11-25
37001SUPPL2011-11-23
27860SUPPL2011-11-22
5453SUPPL2011-11-22
5452SUPPL2011-11-22
42180SUPPL2011-09-22
5454SUPPL2011-03-23
37003SUPPL2011-03-21
37000SUPPL2009-07-09
15530SUPPL2009-07-09
27859SUPPL2009-07-08
27858SUPPL2009-07-08
5451SUPPL2009-07-08
36999SUPPL2009-07-06
27857SUPPL2008-10-01
36998SUPPL2008-09-26
27856SUPPL2007-09-11
15529SUPPL2007-09-11
36997SUPPL2007-02-21
27855SUPPL2007-02-12
27854SUPPL2006-08-04
15528SUPPL2006-08-04
23664ORIG2005-04-15
5450SUPPL2004-08-25
15527SUPPL2004-08-19
42179ORIG2004-03-28
44477ORIG2004-02-05
36996ORIG2004-02-05
23073ORIG2004-02-05
5449ORIG2004-02-05
64046ORIG1900-01-01
64045ORIG1900-01-01
64044ORIG1900-01-01
58112ORIG1900-01-01
53391ORIG1900-01-01
53390ORIG1900-01-01
53389ORIG1900-01-01