Manufacturing Establishments8
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Patheon Manufacturing Services LLC
Takeda Pharmaceuticals America, Inc.
079415560
Element Materials Technology Pharma US LLC
Takeda Pharmaceuticals America, Inc.
081315325
Microbac Laboratories, Inc.
Takeda Pharmaceuticals America, Inc.
178463126
Triclinic Labs
Takeda Pharmaceuticals America, Inc.
017662237
Catalent Germany Schorndorf GmbH
Takeda Pharmaceuticals America, Inc.
315732628
BCM Ltd
Takeda Pharmaceuticals America, Inc.
230780322
Reckitt Benckiser Healthcare International Ltd.
Takeda Pharmaceuticals America, Inc.
230780363
Reading Scientific Services Ltd (RSSL)
Takeda Pharmaceuticals America, Inc.
293610085
Products5
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Fosrenol
Product Details
NDC Product Code
54092-254Application Number
NDA021468Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
December 20, 2023MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
Lanthanum carbonateActive
Code: 490D9F069TClass: ACTIMQuantity: 1000 mg in 1 1
DEXTRATESInactive
Code: G263MI44RUClass: IACT
Fosrenol
Product Details
NDC Product Code
54092-253Application Number
NDA021468Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
December 20, 2023Lanthanum carbonateActive
Code: 490D9F069TClass: ACTIMQuantity: 750 mg in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
DEXTRATESInactive
Code: G263MI44RUClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
Fosrenol
Product Details
NDC Product Code
54092-252Application Number
NDA021468Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
December 20, 2023Lanthanum carbonateActive
Code: 490D9F069TClass: ACTIMQuantity: 500 mg in 1 1
DEXTRATESInactive
Code: G263MI44RUClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
Fosrenol
Product Details
NDC Product Code
54092-257Application Number
NDA204734Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
December 20, 2023DEXTRATESInactive
Code: G263MI44RUClass: IACT
Lanthanum carbonateActive
Code: 490D9F069TClass: ACTIMQuantity: 1000 mg in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
Fosrenol
Product Details
NDC Product Code
54092-256Application Number
NDA204734Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
December 20, 2023Lanthanum carbonateActive
Code: 490D9F069TClass: ACTIMQuantity: 750 mg in 1 1
DEXTRATESInactive
Code: G263MI44RUClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT