FDA.reportPublic FDA data

Application 080157

Type
ANDA
Sponsor
DAVA PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PYRAZINAMIDEPYRAZINAMIDETABLET;ORAL500MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0904-6696PyrazinamidePyrazinamideMajor PharmaceuticalsANDACurrent
0904-6696PyrazinamidePyrazinamideMajor PharmaceuticalsANDACurrent
0904-6696PyrazinamidePyrazinamideMajor PharmaceuticalsANDACurrent
10135-735PYRAZINAMIDEpyrazinamide tabletMARLEX PHARMACEUTICALS, INCANDACurrent
50090-0521PyrazinamidePyrazinamideA-S Medication SolutionsANDACurrent
50090-0521PyrazinamidePyrazinamideA-S Medication SolutionsANDACurrent
50090-5963PyrazinamidePyrazinamideA-S Medication SolutionsANDACurrent
60687-138PyrazinamidePyrazinamideAmerican Health PackagingANDACurrent
60687-138PyrazinamidePyrazinamideAmerican Health PackagingANDACurrent
60687-138PyrazinamidePyrazinamideAmerican Health PackagingANDACurrent
67253-660PyrazinamidePyrazinamideDAVA Pharmaceuticals, Inc.ANDACurrent
67253-660PyrazinamidePyrazinamidePar PharmaceuticalANDACurrent
70518-0085PyrazinamidePyrazinamideREMEDYREPACK INC.ANDACurrent
70518-0085PyrazinamidePyrazinamideREMEDYREPACK INC.ANDACurrent
70518-0085PyrazinamidePyrazinamideREMEDYREPACK INC.ANDACurrent
70518-0085PyrazinamidePyrazinamideREMEDYREPACK INC.ANDACurrent
70954-484PyrazinamidePyrazinamideNovitium Pharma LLCANDACurrent