zolmitriptan Disintegrating Oral Tablet

Brand(s)
Zomig
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Astrazeneca Pharmaceuticals Lp (2008-10-29)
Oldest Current Product
2001-04-02
License(s)
NDA, ANDA
RxNORM
DISINTEGRATING ORAL TABLET\ZOLMITRIPTAN
FDAOB
ORAL\TABLET, ORALLY DISINTEGRATING\ZOLMITRIPTAN
SPL Active
ORAL\TABLET, ORALLY DISINTEGRATING\ZOLMITRIPTAN
SPL Moiety
ORAL\TABLET, ORALLY DISINTEGRATING\ZOLMITRIPTAN

product(s) by strength(s)

zolmitriptan 2.5 mg disintegrating oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001150691NDAGlobal Pharmaceuticals2013-05-14ZOLMITRIPTANORALTABLET, ORALLY DISINTEGRATINGNDA021231350eb39e-6072-4467-8f57-ed6edcdbccd8
2003100209ZomigNDAAstrazeneca Pharmaceuticals Lp2001-04-02ZOLMITRIPTANORALTABLET, ORALLY DISINTEGRATINGNDA021231ed2c8d3f-4b4d-437f-09ae-35d9ea0c5114

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1333420139ANDAMacleods Pharmaceuticals Limited2015-10-22ZOLMITRIPTANORALTABLET, ORALLY DISINTEGRATINGANDA204336062b0049-693b-4ab5-9c51-c16127108afe
2597460461ANDAJubilant Cadista Pharmaceuticals, Inc.2015-09-17ZOLMITRIPTANORALTABLET, ORALLY DISINTEGRATINGANDA202956a6a32fc6-4243-9cdd-91c7-b8a58e0f9811
3605053718ANDAApotex Corp2013-05-14ZOLMITRIPTANORALTABLET, ORALLY DISINTEGRATINGANDA2024769842232d-83bf-fa08-5c5c-ba10fe5783e8
4658410767ANDACadila Healthcare Limited2013-05-16ZOLMITRIPTANORALTABLET, ORALLY DISINTEGRATINGANDA202890aae2d9cb-9938-4032-961f-f0afd1958b5d
5683820715ANDAZydus Pharmaceuticals (Usa) Inc.2013-05-16ZOLMITRIPTANORALTABLET, ORALLY DISINTEGRATINGANDA2028907fc95729-2f5d-4d5c-b26c-3a13854f73e3
6684620499ANDAGlenmark Generics Inc., Usa2013-05-14ZOLMITRIPTANORALTABLET, ORALLY DISINTEGRATINGANDA202560a734b368-6008-441c-ab44-5634e46be9a4

zolmitriptan 5 mg disintegrating oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001150692NDAGlobal Pharmaceuticals2013-05-14ZOLMITRIPTANORALTABLET, ORALLY DISINTEGRATINGNDA021231350eb39e-6072-4467-8f57-ed6edcdbccd8
2003100213ZomigNDAAstrazeneca Pharmaceuticals Lp2001-10-01ZOLMITRIPTANORALTABLET, ORALLY DISINTEGRATINGNDA021231ed2c8d3f-4b4d-437f-09ae-35d9ea0c5114

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1333420140ANDAMacleods Pharmaceuticals Limited2015-10-22ZOLMITRIPTANORALTABLET, ORALLY DISINTEGRATINGANDA204336062b0049-693b-4ab5-9c51-c16127108afe
2597460462ANDAJubilant Cadista Pharmaceuticals, Inc.2015-09-17ZOLMITRIPTANORALTABLET, ORALLY DISINTEGRATINGANDA202956a6a32fc6-4243-9cdd-91c7-b8a58e0f9811
3605053719ANDAApotex Corp2013-05-14ZOLMITRIPTANORALTABLET, ORALLY DISINTEGRATINGANDA2024769842232d-83bf-fa08-5c5c-ba10fe5783e8
4684620500ANDAGlenmark Generics Inc., Usa2013-05-14ZOLMITRIPTANORALTABLET, ORALLY DISINTEGRATINGANDA202560a734b368-6008-441c-ab44-5634e46be9a4

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA202476ZOLMITRIPTANAPOTEX INC2013-05-14ANDA202476_001, ANDA202476_002
2ANDA202560ZOLMITRIPTANGLENMARK GENERICS LTD2013-05-14ANDA202560_001, ANDA202560_002
3ANDA202890ZOLMITRIPTANZYDUS PHARMACEUTICALS USA INC2013-05-15ANDA202890_001, ANDA202890_002
4ANDA202956ZOLMITRIPTANJUBILANT GENERICS LTD2015-09-17ANDA202956_001, ANDA202956_002
5ANDA204336ZOLMITRIPTANMACLEODS PHARMACEUTICALS LTD2015-10-22ANDA204336_001, ANDA204336_002
6NDA021231ZOMIG-ZMTASTRAZENECA PHARMACEUTICALS LP2001-02-13NDA021231_001, NDA021231_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA202476_001RXZOLMITRIPTAN (2.5MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2013-05-14ZOLMITRIPTAN
2ANDA202476_002RXZOLMITRIPTAN (5MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2013-05-14ZOLMITRIPTAN
3ANDA202560_001RXZOLMITRIPTAN (2.5MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2013-05-14ZOLMITRIPTAN
4ANDA202560_002RXZOLMITRIPTAN (5MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2013-05-14ZOLMITRIPTAN
5ANDA202890_001RXZOLMITRIPTAN (2.5MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2013-05-15ZOLMITRIPTAN
6ANDA202890_002RXZOLMITRIPTAN (5MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2013-05-15ZOLMITRIPTAN
7ANDA202956_001RXZOLMITRIPTAN (2.5MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2015-09-17ZOLMITRIPTAN
8ANDA202956_002RXZOLMITRIPTAN (5MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2015-09-17ZOLMITRIPTAN
9ANDA204336_001RXZOLMITRIPTAN (2.5MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2015-10-22ZOLMITRIPTAN
10ANDA204336_002RXZOLMITRIPTAN (5MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2015-10-22ZOLMITRIPTAN
11NDA021231_001RXZOLMITRIPTAN (2.5MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2001-02-13ZOMIG-ZMT
12NDA021231_002RXZOLMITRIPTAN (5MG)ORALTABLET, ORALLY DISINTEGRATINGTrueAB2001-09-17ZOMIG-ZMT

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, PACK2015-10-312333420139, 333420140, 333420112, 333420113zolmitriptan Oral Tablet
2350eb39e-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 Pharmaceuticals2013-05-141001150691, 001150692, 001150671, 001150672zolmitriptan Oral Tablet
37fc95729-2f5d-4d5c-b26c-3a13854f73e3 (view SPL)These highlights do not include all the information needed to use zolmitriptan safely and effectively. See full prescribing information for zolmitriptan. ZOLMITRIPTAN Orally Disintegrating Tablets, for oral use Initial U.S. Approval: 1997prescriptionHuman PrescriptionZydus Pharmaceuticals (Usa) Inc.Analysis, Manufacture2013-03-091683820715
49842232d-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, manufacture2013-03-134605053718, 605053719, 605053693, 605053694zolmitriptan Oral Tablet
5a6a32fc6-4243-9cdd-91c7-b8a58e0f9811 (view SPL)These highlights do not include all the information needed to use zolmitriptan orally disintegrating tablets safely and effectively. See full prescribing information for zolmitriptan orally disintegrating tablets. ZOLMITRIPTAN Orally Disintegrating Tablets, for oral use Initial U.S. Approval: 1997prescriptionHuman PrescriptionJubilant Cadista Pharmaceuticals, Inc.MANUFACTURE2015-09-183597460461, 597460462
6a734b368-6008-441c-ab44-5634e46be9a4 (view SPL)These highlights do not include all the information needed to use zolmitriptan safely and effectively. See full prescribing information for zolmitriptan. ZOLMITRIPTAN Orally Disintegrating Tablets Initial U.S. Approval: 1997prescriptionHuman PrescriptionGlenmark Generics Inc., UsaANALYSIS, MANUFACTURE2013-05-145684620499, 684620500
7aae2d9cb-9938-4032-961f-f0afd1958b5d (view SPL)These highlights do not include all the information needed to use zolmitriptan safely and effectively. See full prescribing information for zolmitriptan. ZOLMITRIPTAN Orally Disintegrating Tablets, for oral use Initial U.S. Approval: 1997prescriptionHuman PrescriptionCadila Healthcare LimitedAnalysis, Manufacture2013-05-031658410767
8df93b636-103f-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 Oral Tablet
9ed2c8d3f-4b4d-437f-09ae-35d9ea0c5114 (view SPL)ZOMIG (zolmitriptan) TABLETS ZOMIG-ZMT (zolmitriptan) ORALLY DISINTEGRATING TABLETSprescriptionHuman PrescriptionAstrazeneca Pharmaceuticals Lp2008-10-2914003100209, 003100213, 003100210, 003100211zolmitriptan Oral Tablet

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