Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Cerovene, Inc.
790387927
Manufacturing Establishments2
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Cerovene, Inc.
DR.REDDYS LABORATORIES INC
Cerovene, Inc.
790387927
Nutra-Med Packaging, Inc.
DR.REDDYS LABORATORIES INC
Cerovene, Inc.
022004902
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
43598-672Application Number
ANDA207127Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
March 20, 2023STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
PyrimethamineActive
Code: Z3614QOX8WClass: ACTIBQuantity: 25 mg in 1 1
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT