zolmitriptan Oral Tablet

Brand(s)
Zomig
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Global Pharmaceuticals (2013-05-14)
Oldest Current Product
2010-05-18
License(s)
NDA, ANDA
RxNORM
ORAL TABLET\ZOLMITRIPTAN
FDAOB
ORAL\TABLET\ZOLMITRIPTAN
SPL Active
ORAL\TABLET, FILM COATED\ZOLMITRIPTAN
ORAL\TABLET\ZOLMITRIPTAN
SPL Moiety
ORAL\TABLET, FILM COATED\ZOLMITRIPTAN
ORAL\TABLET\ZOLMITRIPTAN

product(s) by strength(s)

zolmitriptan 2.5 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001150671NDAGlobal Pharmaceuticals2013-05-14ZOLMITRIPTANORALTABLETNDA020768350eb39e-6072-4467-8f57-ed6edcdbccd8
2648960671ZomigNDAImpax Laboratories, Inc.2012-04-02ZOLMITRIPTANORALTABLETNDA020768df93b636-103f-4fb5-26b6-50f639e29b1d

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003784260ANDAMylan Pharmaceuticals Inc.2013-05-14ZOLMITRIPTANORALTABLET, FILM COATEDANDA2031866524cdbd-9919-4f59-80f0-a049fbabcd22
2317220458ANDACamber Pharmaceuticals, Inc.2015-01-05ZOLMITRIPTANORALTABLET, FILM COATEDANDA204284ac89615d-7618-4c7c-8d4e-1bc74b1f7141
3333420112ANDAMacleods Pharmaceuticals Limited2015-09-30ZOLMITRIPTANORALTABLET, FILM COATEDANDA203772062b0049-693b-4ab5-9c51-c16127108afe
4473350978ANDASun Pharma Global Fze2014-11-24ZOLMITRIPTANORALTABLET, FILM COATEDANDA203476e51e6a86-7549-4e3b-a771-ea6892d4d444
5597460432ANDAJubilant Cadista Pharmaceuticals, Inc.2014-11-20ZOLMITRIPTANORALTABLET, FILM COATEDANDA2022798b4fe798-ccbd-e0cc-d219-5a70d8115f43
6605053693ANDAApotex Corp2013-05-14ZOLMITRIPTANORALTABLET, FILM COATEDANDA2020789842232d-83bf-fa08-5c5c-ba10fe5783e8
7680010249ANDABluepoint Laboratories2014-03-13ZOLMITRIPTANORALTABLET, FILM COATEDANDA201779e6628b7a-0b63-4e6f-a5e7-2fa195265235
8684620497ANDAGlenmark Generics Inc., Usa2013-05-14ZOLMITRIPTANORALTABLET, FILM COATEDANDA201779333caafc-2e63-49f8-a0c6-534e528d228d

zolmitriptan 5 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001150672NDAGlobal Pharmaceuticals2013-05-14ZOLMITRIPTANORALTABLETNDA020768350eb39e-6072-4467-8f57-ed6edcdbccd8
2648960672ZomigNDAImpax Laboratories, Inc.2012-04-02ZOLMITRIPTANORALTABLETNDA020768df93b636-103f-4fb5-26b6-50f639e29b1d

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003784261ANDAMylan Pharmaceuticals Inc.2013-05-14ZOLMITRIPTANORALTABLET, FILM COATEDANDA2031866524cdbd-9919-4f59-80f0-a049fbabcd22
2317220459ANDACamber Pharmaceuticals, Inc.2015-01-05ZOLMITRIPTANORALTABLET, FILM COATEDANDA204284ac89615d-7618-4c7c-8d4e-1bc74b1f7141
3333420113ANDAMacleods Pharmaceuticals Limited2015-09-30ZOLMITRIPTANORALTABLET, FILM COATEDANDA203772062b0049-693b-4ab5-9c51-c16127108afe
4473350979ANDASun Pharma Global Fze2014-11-24ZOLMITRIPTANORALTABLET, FILM COATEDANDA203476e51e6a86-7549-4e3b-a771-ea6892d4d444
5597460433ANDAJubilant Cadista Pharmaceuticals, Inc.2014-11-20ZOLMITRIPTANORALTABLET, FILM COATEDANDA2022798b4fe798-ccbd-e0cc-d219-5a70d8115f43
6605053694ANDAApotex Corp2013-05-14ZOLMITRIPTANORALTABLET, FILM COATEDANDA2020789842232d-83bf-fa08-5c5c-ba10fe5783e8
7680010250ANDABluepoint Laboratories2014-03-13ZOLMITRIPTANORALTABLET, FILM COATEDANDA201779e6628b7a-0b63-4e6f-a5e7-2fa195265235
8684620498ANDAGlenmark Generics Inc., Usa2013-05-14ZOLMITRIPTANORALTABLET, FILM COATEDANDA201779333caafc-2e63-49f8-a0c6-534e528d228d

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1682587103ZomigNDADispensing Solutions, Inc.2010-05-18ZOLMITRIPTANORALTABLET003100211NDA02076856b3e77b-4e5f-4a3d-bad0-9e83033a5544

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA090861ZOLMITRIPTANTEVA PHARMACEUTICALS USA2014-03-04ANDA090861_001, ANDA090861_002
2ANDA201779ZOLMITRIPTANGLENMARK GENERICS LTD2013-05-14ANDA201779_001, ANDA201779_002
3ANDA202078ZOLMITRIPTANAPOTEX INC2013-05-14ANDA202078_001, ANDA202078_002
4ANDA202279ZOLMITRIPTANJUBILANT GENERICS LTD2014-11-20ANDA202279_001, ANDA202279_002
5ANDA203186ZOLMITRIPTANMYLAN PHARMACEUTICALS INC2013-05-14ANDA203186_001, ANDA203186_002
6ANDA203476ZOLMITRIPTANSUN PHARMA GLOBAL FZE2014-11-13ANDA203476_001, ANDA203476_002
7ANDA203772ZOLMITRIPTANMACLEODS PHARMACEUTICALS LTD2015-09-30ANDA203772_001, ANDA203772_002
8ANDA204232ZOLMITRIPTANALEMBIC PHARMACEUTICALS LTD2015-09-30ANDA204232_001, ANDA204232_002
9ANDA204284ZOLMITRIPTANINVAGEN PHARMACEUTICALS INC2014-04-09ANDA204284_001, ANDA204284_002
10NDA020768ZOMIGIPR PHARMACEUTICALS INC1997-11-25NDA020768_001, NDA020768_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA090861_001RXZOLMITRIPTAN (2.5MG)ORALTABLETFalseAB2014-03-04ZOLMITRIPTAN
2ANDA090861_002RXZOLMITRIPTAN (5MG)ORALTABLETFalseAB2014-03-04ZOLMITRIPTAN
3ANDA201779_001RXZOLMITRIPTAN (2.5MG)ORALTABLETFalseAB2013-05-14ZOLMITRIPTAN
4ANDA201779_002RXZOLMITRIPTAN (5MG)ORALTABLETFalseAB2013-05-14ZOLMITRIPTAN
5ANDA202078_001RXZOLMITRIPTAN (2.5MG)ORALTABLETFalseAB2013-05-14ZOLMITRIPTAN
6ANDA202078_002RXZOLMITRIPTAN (5MG)ORALTABLETFalseAB2013-05-14ZOLMITRIPTAN
7ANDA202279_001RXZOLMITRIPTAN (2.5MG)ORALTABLETFalseAB2014-11-20ZOLMITRIPTAN
8ANDA202279_002RXZOLMITRIPTAN (5MG)ORALTABLETFalseAB2014-11-20ZOLMITRIPTAN
9ANDA203186_001RXZOLMITRIPTAN (2.5MG)ORALTABLETFalseAB2013-05-14ZOLMITRIPTAN
10ANDA203186_002RXZOLMITRIPTAN (5MG)ORALTABLETFalseAB2013-05-14ZOLMITRIPTAN
11ANDA203476_001RXZOLMITRIPTAN (2.5MG)ORALTABLETFalseAB2014-11-13ZOLMITRIPTAN
12ANDA203476_002RXZOLMITRIPTAN (5MG)ORALTABLETFalseAB2014-11-13ZOLMITRIPTAN
13ANDA203772_001RXZOLMITRIPTAN (2.5MG)ORALTABLETFalseAB2015-09-30ZOLMITRIPTAN
14ANDA203772_002RXZOLMITRIPTAN (5MG)ORALTABLETFalseAB2015-09-30ZOLMITRIPTAN
15ANDA204232_001RXZOLMITRIPTAN (2.5MG)ORALTABLETFalseAB2015-09-30ZOLMITRIPTAN
16ANDA204232_002RXZOLMITRIPTAN (5MG)ORALTABLETFalseAB2015-09-30ZOLMITRIPTAN
17ANDA204284_001RXZOLMITRIPTAN (2.5MG)ORALTABLETFalseAB2014-04-09ZOLMITRIPTAN
18ANDA204284_002RXZOLMITRIPTAN (5MG)ORALTABLETFalseAB2014-04-09ZOLMITRIPTAN
19NDA020768_001RXZOLMITRIPTAN (2.5MG)ORALTABLETFalseAB1997-11-25ZOMIG
20NDA020768_002RXZOLMITRIPTAN (5MG)ORALTABLETTrueAB1997-11-25ZOMIG

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
1062b0049-693b-4ab5-9c51-c16127108afe (view SPL)These highlights do not include all the information needed to use ZOLMITRIPTAN TABLETS or ZOLMITRIPTAN ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ZOLMITRIPTAN TABLETS and ZOLMITRIPTAN ORALLY DISINTEGRATING TABLETS.ZOLMITRIPTAN tablets, for oral use ZOLMITRIPTAN, orally disintegrating tabletsInitial U.S. Approval: 1997prescriptionHuman PrescriptionMacleods Pharmaceuticals LimitedANALYSIS, LABEL, MANUFACTURE, PACK2015-10-312333420112, 333420113, 333420139, 333420140zolmitriptan Disintegrating Oral Tablet
2333caafc-2e63-49f8-a0c6-534e528d228d (view SPL)These highlights do not include all the information needed to use zolmitriptan safely and effectively. See full prescribing information for zolmitriptan. ZOLMITRIPTAN Tablets, for oral use Initial U.S. Approval: 1997prescriptionHuman PrescriptionGlenmark Generics Inc., UsaANALYSIS, MANUFACTURE2013-05-146684620497, 684620498
3350eb39e-6072-4467-8f57-ed6edcdbccd8 (view SPL)These highlights do not include all the information needed to use zolmitriptan tablets or zolmitriptan orally disintegrating tablets safely and effectively. See full prescribing information for zolmitriptan tablets or zolmitriptan orally disintegrating tablets.Zolmitriptan tablets, for oral useZolmitriptan orally disintegrating tabletsInitial U.S. Approval: 1997prescriptionHuman PrescriptionGlobal Pharmaceuticals2013-05-141001150671, 001150672, 001150691, 001150692zolmitriptan Disintegrating Oral Tablet
456b3e77b-4e5f-4a3d-bad0-9e83033a5544 (view SPL)ZOMIG (zolmitriptan) TABLETSZOMIG-ZMT (zolmitriptan)ORALLY DISINTEGRATING TABLETSprescriptionHuman PrescriptionDispensing Solutions, Inc.relabel, repack2011-10-102682587103
56524cdbd-9919-4f59-80f0-a049fbabcd22 (view SPL)These highlights do not include all the information needed to use zolmitriptan tablets safely and effectively. See full prescribing information for zolmitriptan tablets.Zolmitriptan Tablets, for Oral Use Initial U.S. Approval: 1997prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2013-03-132003784260, 003784261
68b4fe798-ccbd-e0cc-d219-5a70d8115f43 (view SPL)These highlights do not include all the information needed to use zolmitriptan tablets safely and effectively. See full prescribing information for zolmitriptan tablets. ZOLMITRIPTANtablets, for oral use Initial U.S. Approval: 1997prescriptionHuman PrescriptionJubilant Cadista Pharmaceuticals, Inc.MANUFACTURE2014-12-084597460432, 597460433
79842232d-83bf-fa08-5c5c-ba10fe5783e8 (view SPL)These highlights do not include all the information needed to use ZOLMITRIPTAN Tablets or ZOLMITRIPTAN Orally Disintegrating Tablets safely and effectively. See full prescribing information for ZOLMITRIPTAN Tablets and ZOLMITRIPTAN Orally Disintegrating Tablets. ZOLMITRIPTAN Tablets, for oral use ZOLMITRIPTAN Orally Disintegrating Tablets Initial U.S. Approval: 1997prescriptionHuman PrescriptionApotex Corpanalysis, manufacture2013-03-134605053693, 605053694, 605053718, 605053719zolmitriptan Disintegrating Oral Tablet
8ac89615d-7618-4c7c-8d4e-1bc74b1f7141 (view SPL)These highlights do not include all the information needed to use zolmitriptan tablets safely and effectively. See full prescribing information for zolmitriptan tablets.ZOLMITRIPTAN Tablets, for Oral UseInitial U.S. Approval: 1997prescriptionHuman PrescriptionCamber Pharmaceuticals, Inc.manufacture2014-12-302317220458, 317220459
9df93b636-103f-4fb5-26b6-50f639e29b1d (view SPL)These highlights do not include all the information needed to use ZOMIG or ZOMIG-ZMT safely and effectively. See full prescribing information for ZOMIG or ZOMIG-ZMT.ZOMIG (zolmitriptan) tablets, for oral useZOMIG-ZMT (zolmitriptan), orally disintegrating tablets (Initial U.S. Approval: 1997prescriptionHuman PrescriptionImpax Laboratories, Inc.2012-09-147648960671, 648960672, 648960691, 648960692zolmitriptan Disintegrating Oral Tablet
10e51e6a86-7549-4e3b-a771-ea6892d4d444 (view SPL)These highlights do not include all the information needed to use zolmitriptan safely and effectively. See full prescribing information for zolmitriptan tablets.ZOLMITRIPTAN Tablets, for oral useInitial U.S. Approval: 1997prescriptionHuman PrescriptionSun Pharma Global FzeANALYSIS, MANUFACTURE2014-11-244473350978, 473350979
11e6628b7a-0b63-4e6f-a5e7-2fa195265235 (view SPL)These highlights do not include all the information needed to use zolmitriptan safely and effectively. See full prescribing information for zolmitriptan.ZOLMITRIPTAN Tablets, for oral useInitial U.S. Approval: 1997prescriptionHuman PrescriptionBluepoint LaboratoriesANALYSIS, MANUFACTURE2015-08-123680010249, 680010250
12ed2c8d3f-4b4d-437f-09ae-35d9ea0c5114 (view SPL)ZOMIG (zolmitriptan) TABLETS ZOMIG-ZMT (zolmitriptan) ORALLY DISINTEGRATING TABLETSprescriptionHuman PrescriptionAstrazeneca Pharmaceuticals Lp2008-10-2914003100209, 003100210, 003100211, 003100213zolmitriptan Disintegrating Oral Tablet

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