Products3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
PEMAZYRE
Product Details
NDC Product Code
50881-028Application Number
NDA213736Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
June 1, 2023PemigatinibActive
Code: Y6BX7BL23KClass: ACTIBQuantity: 13.5 mg in 1 1
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
PEMAZYRE
Product Details
NDC Product Code
50881-026Application Number
NDA213736Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
June 1, 2023SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
PemigatinibActive
Code: Y6BX7BL23KClass: ACTIBQuantity: 4.5 mg in 1 1
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
PEMAZYRE
Product Details
NDC Product Code
50881-027Application Number
NDA213736Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
June 1, 2023PemigatinibActive
Code: Y6BX7BL23KClass: ACTIBQuantity: 9 mg in 1 1
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT