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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 080157


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NDA 080157 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 080157
Tradename:PYRAZINAMIDE
Applicant:Novitium Pharma
Ingredient:pyrazinamide
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 080157
Medical Subject Heading (MeSH) Categories for 080157
Suppliers and Packaging for NDA: 080157
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PYRAZINAMIDE pyrazinamide TABLET;ORAL 080157 ANDA MARLEX PHARMACEUTICALS, INC 10135-735 10135-735-01 100 TABLET in 1 BOTTLE (10135-735-01)
PYRAZINAMIDE pyrazinamide TABLET;ORAL 080157 ANDA MARLEX PHARMACEUTICALS, INC 10135-735 10135-735-60 60 TABLET in 1 BOTTLE (10135-735-60)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

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