MedPath
FDA Approval

Pyrazinamide

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

FDA Approval Summary

Company
Effective Date
December 6, 2022
Labeling Type
Human Prescription Drug Label
Pyrazinamide(500 mg in 1 1)

Manufacturing Establishments1

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

Macleods Pharmaceuticals Limited

Macleods Pharmaceuticals Limited

918608365

Products1

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

Pyrazinamide

Product Details

NDC Product Code
33342-447
Application Number
ANDA212541
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
December 6, 2022
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
Code: 2KNI5N06TIClass: ACTIBQuantity: 500 mg in 1 1
TALCInactive
Code: 7SEV7J4R1UClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
© Copyright 2025. All Rights Reserved by MedPath
Pyrazinamide - FDA Approval | MedPath