Application 215179

Type
NDA
Sponsor
SHILPA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PEMETREXEDPEMETREXED DISODIUMSOLUTION;INTRAVENOUSEQ 100MG/10ML BASE (10MG/ML)YesYes
002PEMETREXEDPEMETREXED DISODIUMSOLUTION;INTRAVENOUSEQ 500MG/50ML BASE (10MG/ML)YesYes
003PEMETREXEDPEMETREXED DISODIUMSOLUTION;INTRAVENOUSEQ 1GM/100ML BASE (10MG/ML)YesYes

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80238SUPPL 2024-11-19
80237SUPPL 2024-11-19
77460ORIG 2024-02-09
74356ORIG 2023-05-23
74354ORIG 2023-05-23