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FDA Approval

Pyrimethamine Leucovorin

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

FDA Approval Summary

Effective Date
November 27, 2015
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Leucovorin(10 mg in 1 1)
Pyrimethamine(50 mg in 1 1)

Products1

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

Pyrimethamine Leucovorin

Product Details

NDC Product Code
70271-428
Route of Administration
ORAL
Effective Date
November 27, 2015
Code: RPR1R4C0P4Class: ACTIMQuantity: 10 mg in 1 1
Code: Z3614QOX8WClass: ACTIBQuantity: 50 mg in 1 1
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACTQuantity: 72 mg in 1 1

Drug Labeling Information

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pyrimethamine Leucovorin (50mg-10mg)

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SPL UNCLASSIFIED SECTION


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