Pyrazinamide Oral Tablet

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Dava Pharmaceuticals, Inc. (2013-06-01)
Oldest Current Product
1971-06-03
License(s)
ANDA
RxNORM
ORAL TABLET\PYRAZINAMIDE
FDAOB
ORAL\TABLET\PYRAZINAMIDE
SPL Active
ORAL\TABLET\PYRAZINAMIDE
SPL Moiety
ORAL\TABLET\PYRAZINAMIDE

product(s) by strength(s)

pyrazinamide 500 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1466720108ANDAMikart, Inc.1992-06-30PYRAZINAMIDEORALTABLETANDA0813195281495e-b7cd-4f56-89ce-ac950ec1cd9c
2617480012ANDAVersapharm Incorporated1995-04-01PYRAZINAMIDEORALTABLETANDA081319ecee3128-a47f-4ced-a1db-4f58c5f3e9c6
3672530660ANDADava Pharmaceuticals, Inc.1971-06-03PYRAZINAMIDEORALTABLETANDA080157257bd8cf-74d7-45db-bf25-354a8d26634e

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1242360763ANDARemedyrepack Inc.2013-08-21, 2015-06-29PYRAZINAMIDEORALTABLET672530660ANDA080157999aeb7d-1f49-42b0-8b68-95fe9ae9bf9e, dd5cde5a-4b8b-4b16-92f4-a4b77f5b4ba3
2493490344ANDARemedyrepack Inc.2011-06-30PYRAZINAMIDEORALTABLET617480012ANDA08131965314bad-fcc2-4e6d-b4ea-2684b7e212c5
3521250013ANDARemedyrepack Inc.2013-02-26PYRAZINAMIDEORALTABLET617480012ANDA08131900505856-75cc-4f66-947d-0e5e9349fc0e
4581180004ANDAClinical Solutions Wholesale1971-06-03PYRAZINAMIDEORALTABLET672530660ANDA0801575cfd986c-7c44-47dd-9776-b14a96041e77
5606870138ANDAAmerican Health Packaging2015-09-01PYRAZINAMIDEORALTABLET672530660ANDA08015764775df6-9aab-4242-803e-cf613d0dc8ea

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA080157PYRAZINAMIDEDAVA PHARMACEUTICALS INCANDA080157_001
2ANDA081319PYRAZINAMIDEMIKART INC1992-06-30ANDA081319_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA080157_001RXPYRAZINAMIDE (500MG)ORALTABLETTrueABPYRAZINAMIDE
2ANDA081319_001RXPYRAZINAMIDE (500MG)ORALTABLETFalseAB1992-06-30PYRAZINAMIDE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
100505856-75cc-4f66-947d-0e5e9349fc0e (view SPL)PYRAZINAMIDE TABLETS USP, 500 mgprescriptionHuman PrescriptionRemedyrepack Inc.2013-02-261521250013
2257bd8cf-74d7-45db-bf25-354a8d26634e (view SPL)PYRAZINAMIDE TABLETS, USP 500 mg Rx OnlyprescriptionHuman PrescriptionDava Pharmaceuticals, Inc.ANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK2013-06-012672530660
35281495e-b7cd-4f56-89ce-ac950ec1cd9c (view SPL)prescriptionHuman PrescriptionMikart, Inc.2015-05-281466720108
45cfd986c-7c44-47dd-9776-b14a96041e77 (view SPL)PYRAZINAMIDE TABLETS, USP 500 mg Rx OnlyprescriptionHuman PrescriptionClinical Solutions Wholesalerepack2015-08-053581180004
564775df6-9aab-4242-803e-cf613d0dc8ea (view SPL)Pyrazinamide Tablets, USPprescriptionHuman PrescriptionAmerican Health PackagingREPACK2015-08-261606870138
665314bad-fcc2-4e6d-b4ea-2684b7e212c5 (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2011-06-301493490344
7999aeb7d-1f49-42b0-8b68-95fe9ae9bf9e (view SPL)PYRAZINAMIDETABLETS, USP500 mgRx OnlyRev. 01/10prescriptionHuman PrescriptionRemedyrepack Inc.2013-08-211242360763
8dd5cde5a-4b8b-4b16-92f4-a4b77f5b4ba3 (view SPL)PYRAZINAMIDETABLETS, USP500 mgRx OnlyprescriptionHuman PrescriptionRemedyrepack Inc.2015-06-291242360763
9ecee3128-a47f-4ced-a1db-4f58c5f3e9c6 (view SPL)PYRAZINAMIDE TABLETS USP, 500 mgprescriptionHuman PrescriptionVersapharm IncorporatedMANUFACTURE2012-03-161617480012

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII