FDA.reportPublic FDA data

Application 208297

Type
NDA
Sponsor
DR REDDYS LABS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PEMETREXED FOR INJECTIONPEMETREXEDINJECTABLE;INJECTION100MGNoNo
002PEMETREXED FOR INJECTIONPEMETREXEDINJECTABLE;INJECTION500MGNoNo
003PEMETREXED FOR INJECTIONPEMETREXEDINJECTABLE;INJECTION1GNoNo

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 10 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
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
63035ORIG2020-05-15