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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

Company
South Coast Specialty Compounding, Inc. d/b/a Park Compounding
DUNS: 069419104
Effective Date
November 25, 2015
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Pyrimethamine(25 mg in 1 1)
Leucovorin(5 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
70260-426
Route of Administration
ORAL
Effective Date
November 25, 2015
Code: Z3614QOX8WClass: ACTIBQuantity: 25 mg in 1 1
Code: RPR1R4C0P4Class: ACTIMQuantity: 5 mg in 1 1
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACTQuantity: 90 mg in 1 1
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