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Generated: September 23, 2017

DrugPatentWatch Database Preview

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 five 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. Five suppliers are listed for this compound. Additional details are available on the pyrazinamide profile page.

Summary for NDA: 081319

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
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
PYRAZINAMIDE
pyrazinamide
TABLET;ORAL 081319 ANDA REMEDYREPACK INC. 24236-687 24236-687-02 30 TABLET in 1 BLISTER PACK (24236-687-02)
PYRAZINAMIDE
pyrazinamide
TABLET;ORAL 081319 ANDA Department of State Health Services, Pharmacy Branch 55695-026 55695-026-00 90 TABLET in 1 CONTAINER (55695-026-00)

Summary for product number 001

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


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Serving 500+ biopharmaceutical companies globally:

AstraZeneca
Chubb
Medtronic
Healthtrust
Fish and Richardson
Queensland Health
McKinsey
Merck
Dow
Chinese Patent Office

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