Granisetron Oral Tablet

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Teva Pharmaceuticals Usa Inc (2014-08-28)
Oldest Current Product
2007-12-31
License(s)
ANDA
RxNORM
ORAL TABLET\GRANISETRON
FDAOB
ORAL\TABLET\GRANISETRON HYDROCHLORIDE
SPL Active
ORAL\TABLET, FILM COATED\GRANISETRON HYDROCHLORIDE
ORAL\TABLET\GRANISETRON HYDROCHLORIDE
SPL Moiety
ORAL\TABLET, FILM COATED\GRANISETRON
ORAL\TABLET\GRANISETRON

product(s) by strength(s)

granisetron 1 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000540143ANDARoxane Laboratories, Inc2008-05-16GRANISETRON HYDROCHLORIDEORALTABLETANDA0778428dc1291d-65bc-493c-ad73-870716f0b703
2000937485ANDATeva Pharmaceuticals Usa Inc2008-01-02GRANISETRON HYDROCHLORIDEORALTABLET, FILM COATEDANDA07808002dc4c34-04e8-4f16-8109-b04d600a9c61
3167140221ANDANorthstar Rx Llc2008-04-29GRANISETRON HYDROCHLORIDEORALTABLET, FILM COATEDANDA07867803226fdd-8be5-49a7-b63c-62f08e75cd2d, 7094279a-281a-4e53-ab2a-23fedb8c778a
4516724138ANDATaro Pharmaceuticals U.S.A., Inc.2010-05-28GRANISETRON HYDROCHLORIDEORALTABLET, FILM COATEDANDA0908170d7ec602-fd6a-4750-a5bf-d64b614391d5
5519910735ANDABreckenridge Pharmaceutical, Inc.2009-06-22GRANISETRON HYDROCHLORIDEORALTABLETANDA078969df4b6775-4337-41e0-815a-b064d98c3fe1
6647200198ANDACorepharma, Llc2007-12-31GRANISETRON HYDROCHLORIDEORALTABLET, FILM COATEDANDA078260d0e05816-ccf8-4008-b5de-4d3fbc3de3c1
7678770184ANDAAscend Laboratories, Llc2010-01-01GRANISETRON HYDROCHLORIDEORALTABLETANDA07896965d31bc7-c6a6-4515-8e3a-93e0754540b2

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA077842GRANISETRON HYDROCHLORIDEROXANE LABORATORIES INC2007-12-31ANDA077842_001
2ANDA078037GRANISETRON HYDROCHLORIDECIPLA LTD2008-02-27ANDA078037_001
3ANDA078080GRANISETRON HYDROCHLORIDETEVA PHARMACEUTICALS USA2007-12-31ANDA078080_001
4ANDA078221GRANISETRON HYDROCHLORIDETrueBARR LABORATORIES INC2007-12-31ANDA078221_001
5ANDA078260GRANISETRON HYDROCHLORIDECOREPHARMA LLC2007-12-31ANDA078260_001
6ANDA078678GRANISETRON HYDROCHLORIDEORCHID HEALTHCARE2008-02-13ANDA078678_001
7ANDA078725GRANISETRON HYDROCHLORIDEMYLAN PHARMACEUTICALS INC2008-01-30ANDA078725_001
8ANDA078843GRANISETRON HYDROCHLORIDEAPOTEX INC2008-02-27ANDA078843_001
9ANDA078846GRANISETRON HYDROCHLORIDEDR REDDYS LABORATORIES LTD2009-02-27ANDA078846_001
10ANDA078969GRANISETRON HYDROCHLORIDENATCO PHARMA LTD2009-06-22ANDA078969_001
11ANDA090817GRANISETRON HYDROCHLORIDETARO PHARMACEUTICALS USA INC2010-05-28ANDA090817_001
12NDA020305KYTRILTrueHOFFMANN LA ROCHE INC1995-03-16NDA020305_001, NDA020305_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA077842_001RXGRANISETRON HYDROCHLORIDE (EQ 1MG BASE)ORALTABLETFalseAB2007-12-31GRANISETRON HYDROCHLORIDE
2ANDA078037_001RXGRANISETRON HYDROCHLORIDE (EQ 1MG BASE)ORALTABLETFalseAB2008-02-27GRANISETRON HYDROCHLORIDE
3ANDA078080_001RXGRANISETRON HYDROCHLORIDE (EQ 1MG BASE)ORALTABLETTrueAB2007-12-31GRANISETRON HYDROCHLORIDE
4ANDA078221_001discontinuedGRANISETRON HYDROCHLORIDE (EQ 1MG BASE)ORALTABLETFalse2007-12-31GRANISETRON HYDROCHLORIDE
5ANDA078260_001RXGRANISETRON HYDROCHLORIDE (EQ 1MG BASE)ORALTABLETFalseAB2007-12-31GRANISETRON HYDROCHLORIDE
6ANDA078678_001RXGRANISETRON HYDROCHLORIDE (EQ 1MG BASE)ORALTABLETFalseAB2008-02-13GRANISETRON HYDROCHLORIDE
7ANDA078725_001RXGRANISETRON HYDROCHLORIDE (EQ 1MG BASE)ORALTABLETFalseAB2008-01-30GRANISETRON HYDROCHLORIDE
8ANDA078843_001RXGRANISETRON HYDROCHLORIDE (EQ 1MG BASE)ORALTABLETFalseAB2008-02-27GRANISETRON HYDROCHLORIDE
9ANDA078846_001RXGRANISETRON HYDROCHLORIDE (EQ 1MG BASE)ORALTABLETFalseAB2009-02-27GRANISETRON HYDROCHLORIDE
10ANDA078969_001RXGRANISETRON HYDROCHLORIDE (EQ 1MG BASE)ORALTABLETFalseAB2009-06-22GRANISETRON HYDROCHLORIDE
11ANDA090817_001RXGRANISETRON HYDROCHLORIDE (EQ 1MG BASE)ORALTABLETFalseAB2010-05-28GRANISETRON HYDROCHLORIDE
12NDA020305_001discontinuedGRANISETRON HYDROCHLORIDE (EQ 1MG BASE)ORALTABLETFalse1995-03-16KYTRIL
13NDA020305_002discontinuedGRANISETRON HYDROCHLORIDE (EQ 2MG BASE)ORALTABLETFalse1998-06-15KYTRIL

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
102dc4c34-04e8-4f16-8109-b04d600a9c61 (view SPL)GRANISETRON HYDROCHLORIDE TABLETS USP7485Rx onlyprescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2014-08-286000937485
203226fdd-8be5-49a7-b63c-62f08e75cd2d (view SPL)prescriptionHuman PrescriptionNorthstar Rx Llcanalysis, label, manufacture, pack2014-08-289167140221
30d7ec602-fd6a-4750-a5bf-d64b614391d5 (view SPL)Granisetron Hydrochloride Tablets USP, 1 mgprescriptionHuman PrescriptionTaro Pharmaceuticals U.S.A., Inc.ANALYSIS, API MANUFACTURE, MANUFACTURE2014-08-227516724138
465d31bc7-c6a6-4515-8e3a-93e0754540b2 (view SPL)Granisetron hydrochloride tabletsprescriptionHuman PrescriptionAscend Laboratories, Llc2011-03-214678770184
57094279a-281a-4e53-ab2a-23fedb8c778a (view SPL)prescriptionHuman PrescriptionNorthstar Rx Llcanalysis, label, manufacture, pack2014-08-287167140221
68dc1291d-65bc-493c-ad73-870716f0b703 (view SPL)Granisetron Hydrochloride Tablets USP, 1 mg Rx onlyprescriptionHuman PrescriptionRoxane Laboratories, IncMANUFACTURE2015-10-226000540143
7d0e05816-ccf8-4008-b5de-4d3fbc3de3c1 (view SPL)GRANISETRON HYDROCHLORIDE TABLETS1 mgRx onlyprescriptionHuman PrescriptionCorepharma, Llc2014-08-267647200198
8df4b6775-4337-41e0-815a-b064d98c3fe1 (view SPL)GRANISETRON HYDROCHLORIDE TABLETS, USPprescriptionHuman PrescriptionBreckenridge Pharmaceutical, Inc.2012-02-083519910735

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