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FDA Approval

Lanthanum carbonate

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company

Exelan Pharmaceuticals, Inc.

DUNS: 967795266

Effective Date

June 13, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Lanthanum carbonate(500 mg in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

InvaGen Pharmaceuticals, Inc.

Labeler

Exelan Pharmaceuticals, Inc.

DUNS Number

165104469

Products3

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Lanthanum carbonate

Product Details

NDC Product Code

76282-476

Application Number

ANDA206868

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

June 13, 2023

Ingredients

SUCRALOSEInactive

Code: 96K6UQ3ZD4Class: IACT

GUAR GUMInactive

Code: E89I1637KEClass: IACT

Lanthanum carbonateActive

Code: 490D9F069TClass: ACTIMQuantity: 500 mg in 1 1

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive

Code: 9XZ8H6N6OHClass: IACT

DEXTRATESInactive

Code: G263MI44RUClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65APClass: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

Lanthanum carbonate

Product Details

NDC Product Code

76282-478

Application Number

ANDA206868

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

June 13, 2023

Ingredients

SUCRALOSEInactive

Code: 96K6UQ3ZD4Class: IACT

DEXTRATESInactive

Code: G263MI44RUClass: IACT

Lanthanum carbonateActive

Code: 490D9F069TClass: ACTIMQuantity: 1000 mg in 1 1

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

GUAR GUMInactive

Code: E89I1637KEClass: IACT

HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive

Code: 9XZ8H6N6OHClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65APClass: IACT

Lanthanum carbonate

Product Details

NDC Product Code

76282-477

Application Number

ANDA206868

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

June 13, 2023

Ingredients

STEARIC ACIDInactive

Code: 4ELV7Z65APClass: IACT

Lanthanum carbonateActive

Code: 490D9F069TClass: ACTIMQuantity: 750 mg in 1 1

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

GUAR GUMInactive

Code: E89I1637KEClass: IACT

SUCRALOSEInactive

Code: 96K6UQ3ZD4Class: IACT

HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive

Code: 9XZ8H6N6OHClass: IACT

DEXTRATESInactive

Code: G263MI44RUClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

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