Application 021677

Type
NDA
Sponsor
LILLY

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ALIMTAPEMETREXEDINJECTABLE; INJECTION500MGNoNo

Source provenance: Browse the complete Orange Book source catalog.

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 ยท 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PemfexyPEMETREXEDAcacia Pharma, Ltd.caef07ce-066b-4c48-98dc-974b05ebbbe02026-06-18Warnings, Adverse reactionsName fallback
generic name: PEMETREXED
PemfexyPEMETREXEDEagle Pharmaceuticals, Inc.2308f4e8-21c8-49c1-a5b8-deb8610bac6a2026-02-20Warnings, Adverse reactionsName fallback
generic name: PEMETREXED
PemetrexedPEMETREXEDSolco Healthcare US, LLCbd0ada98-3237-4465-8ba2-3a12c33116fb2025-12-31Warnings, Adverse reactionsName fallback
generic name: PEMETREXED
PEMETREXEDPEMETREXEDHospira, Inc.3ae68628-7ab0-4491-b3ae-6a8330b719c82025-10-08Warnings, Adverse reactionsName fallback
generic name: PEMETREXED
AXTLEPEMETREXEDAvyxa Pharma, LLC9582c46c-d8b0-44b7-a2ee-9c86f5e9b7b12025-10-08Warnings, Adverse reactionsName fallback
generic name: PEMETREXED
PEMETREXEDPEMETREXEDHospira, Inc.3e087418-69ff-47fa-93c2-f286993094332024-07-24Warnings, Adverse reactionsName fallback
generic name: PEMETREXED
PEMETREXEDPEMETREXEDAccord Healthcare Inc.dfd19e67-54cb-c062-e053-2995a90a294a2024-07-18Warnings, Adverse reactionsName fallback
generic name: PEMETREXED
PemetrexedPEMETREXEDBluePoint Laboratories495c6751-8d6f-4093-8108-9bed283fce032023-09-05Warnings, Adverse reactionsName fallback
generic name: PEMETREXED
PemetrexedPEMETREXEDEugia US LLC737ead51-f73c-414f-b68f-d3affc27a2252023-07-27Warnings, Adverse reactionsName fallback
generic name: PEMETREXED
AlimtaPEMETREXED DISODIUMEli Lilly and Companyf5a860f3-37ec-429c-ae04-9c88d7c55c082023-05-19Warnings, Adverse reactionsName fallback
brand name: Alimta
PemetrexedPEMETREXEDTeva Pharmaceuticals, Inc.8b660f68-b770-4e0a-b2f9-25e663deecc32022-12-01Warnings, Adverse reactionsName fallback
generic name: PEMETREXED

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
42267ORIG2006-06-08
23671ORIG2005-04-15
28352ORIG2004-08-25
37437ORIG2004-08-19