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Details for New Drug Application (NDA): 081319

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NDA 081319 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 NDA: 081319

Therapeutic Class:Antimycobacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 081319

Suppliers and Packaging for NDA: 081319

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET;ORAL 081319 ANDA A-S Medication Solutions 50090-0520 50090-0520-0 100 TABLET in 1 CONTAINER (50090-0520-0)
TABLET;ORAL 081319 ANDA A-S Medication Solutions 54569-3950 54569-3950-0 100 TABLET in 1 BOTTLE (54569-3950-0)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Jun 30, 1992TE:ABRLD:No

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