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Generated: December 18, 2018

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Details for New Drug Application (NDA): 080157

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NDA 080157 describes PYRAZINAMIDE, which is a drug marketed by Akorn and Dava Pharms Inc and is included in two 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:Dava Pharms Inc
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 Major Pharmaceuticals 0904-6696 0904-6696-61 100 BLISTER PACK in 1 CARTON (0904-6696-61) > 1 TABLET in 1 BLISTER PACK
PYRAZINAMIDE pyrazinamide TABLET;ORAL 080157 ANDA A-S Medication Solutions 50090-0521 50090-0521-0 100 TABLET in 1 BOTTLE (50090-0521-0)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:No

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