MedPath
FDA Approval

Pyrimethamine

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

FDA Approval Summary

Company
OAKRUM PHARMA, LLC
DUNS: 081507685
Effective Date
November 11, 2021
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Pyrimethamine(25 mg in 1 1)

Manufacturing Establishments3

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

Patheon Manufacturing Services LLC

OAKRUM PHARMA, LLC

079415560

Novitium Pharma LLC

OAKRUM PHARMA, LLC

080301870

Fukuzyu Pharmaceutical Co., Ltd.

OAKRUM PHARMA, LLC

692442510

Products1

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

Pyrimethamine

Product Details

NDC Product Code
72647-330
Application Number
NDA008578
Marketing Category
NDA authorized generic (C73605)
Route of Administration
ORAL
Effective Date
March 18, 2020
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
Code: Z3614QOX8WClass: ACTIBQuantity: 25 mg in 1 1
STARCH, POTATOInactive
Code: 8I089SAH3TClass: IACT
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98GClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
© Copyright 2025. All Rights Reserved by MedPath