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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 212541


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NDA 212541 describes PYRAZINAMIDE, which is a drug marketed by Hikma, Macleods Pharms Ltd, and Novitium Pharma, and is included in three NDAs. It is available from seven suppliers. Additional details are available on the PYRAZINAMIDE profile page.

The generic ingredient in PYRAZINAMIDE is pyrazinamide. There are seven drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the pyrazinamide profile page.
Summary for 212541
Tradename:PYRAZINAMIDE
Applicant:Macleods Pharms Ltd
Ingredient:pyrazinamide
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 212541
Medical Subject Heading (MeSH) Categories for 212541
Suppliers and Packaging for NDA: 212541
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PYRAZINAMIDE pyrazinamide TABLET;ORAL 212541 ANDA Macleods Pharmaceuticals Limited 33342-447 33342-447-03 10 TABLET in 1 BOTTLE (33342-447-03)
PYRAZINAMIDE pyrazinamide TABLET;ORAL 212541 ANDA Macleods Pharmaceuticals Limited 33342-447 33342-447-07 30 TABLET in 1 BOTTLE (33342-447-07)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Jul 27, 2020TE:ABRLD:No

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