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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
Effective Date
February 7, 2024
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Lanthanum carbonate(1000 mg in 1 1)

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
0093-5940
Application Number
ANDA090977
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
February 7, 2024
Code: 490D9F069TClass: ACTIMQuantity: 1000 mg in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
DEXTRATESInactive
Code: G263MI44RUClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT

Lanthanum carbonate

Product Details

NDC Product Code
0093-5938
Application Number
ANDA090977
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
February 7, 2024
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
Code: 490D9F069TClass: ACTIMQuantity: 500 mg in 1 1
DEXTRATESInactive
Code: G263MI44RUClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT

Lanthanum carbonate

Product Details

NDC Product Code
0093-5939
Application Number
ANDA090977
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
February 7, 2024
Code: 490D9F069TClass: ACTIMQuantity: 750 mg in 1 1
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
DEXTRATESInactive
Code: G263MI44RUClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT

Drug Labeling Information

Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.

RECENT MAJOR CHANGES SECTION

RECENT MAJOR CHANGES

Contraindications (4) 8/2024


INDICATIONS & USAGE SECTION

Highlight: * Lanthanum carbonate chewable tablets are a phosphate binder indicated to reduce serum phosphate in patients with end-stage renal disease (ESRD). (1)

1 INDICATIONS AND USAGE

Lanthanum carbonate chewable tablets are a phosphate binder indicated to reduce serum phosphate in patients with end-stage renal disease (ESRD).

Management of elevated serum phosphorus levels in patients with ESRD usually includes all of the following: reduction in dietary intake of phosphate, removal of phosphate by dialysis, and reduction of intestinal phosphate absorption with phosphate binders.

DOSAGE FORMS & STRENGTHS SECTION

Highlight: * Lanthanum carbonate chewable tablets: 500 mg, 750 mg, and 1,000 mg. (3)

3 DOSAGE FORMS AND STRENGTHS

Lanthanum carbonate chewable tablets: 500 mg, 750 mg, and 1,000 mg.


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