naratriptan Oral Tablet

Brand(s)
Amerge
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Glaxosmithkline Llc (2015-08-12)
Oldest Current Product
1998-02-26
License(s)
NDA, ANDA
RxNORM
ORAL TABLET\NARATRIPTAN
FDAOB
ORAL\TABLET\NARATRIPTAN HYDROCHLORIDE
SPL Active
ORAL\TABLET, COATED\NARATRIPTAN HYDROCHLORIDE
ORAL\TABLET, FILM COATED\NARATRIPTAN HYDROCHLORIDE
ORAL\TABLET\NARATRIPTAN HYDROCHLORIDE
SPL Moiety
ORAL\TABLET, COATED\NARATRIPTAN
ORAL\TABLET, FILM COATED\NARATRIPTAN
ORAL\TABLET\NARATRIPTAN

product(s) by strength(s)

naratriptan 1 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001730561AmergeNDAGlaxosmithkline Llc1998-02-26NARATRIPTAN HYDROCHLORIDEORALTABLET, FILM COATEDNDA02076313f4a8ec-75a3-4c51-b3bc-6244f3c79e95

generic product(s)(s)

#idcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1000540278ANDARoxane Laboratories, Inc2010-07-07NARATRIPTAN HYDROCHLORIDEORALTABLETANDA090381fd1944b3-8054-4faa-a82e-d818dfdd3875
2000938522ANDATeva Pharmaceuticals Usa Inc2013-08-122015-11-30NARATRIPTAN HYDROCHLORIDEORALTABLET, FILM COATEDANDA078751db26e43c-8503-4974-bbe0-5703147eced6
3003784450ANDAMylan Pharmaceuticals Inc.2012-06-13NARATRIPTAN HYDROCHLORIDEORALTABLET, FILM COATEDANDA2024317f542b45-a579-4828-8b29-a74ef9a45c6e
4005740214ANDAPaddock Laboratories, Llc2010-07-08NARATRIPTAN HYDROCHLORIDEORALTABLET, FILM COATEDANDA091326b1524990-2757-44bb-a044-dbe92ff9caaa
5007815526ANDASandoz Inc2010-07-07NARATRIPTAN HYDROCHLORIDEORALTABLET, COATEDANDA09028839c658d3-5bc8-4f81-9837-1c4edcf1b6c2
6231550054ANDAHeritage Pharmaceuticals Inc.2011-03-15NARATRIPTAN HYDROCHLORIDEORALTABLETANDA20050241c29652-32f8-48dc-9038-0e2195aa2084
7420430130ANDAOrchidpharma Inc2012-12-12NARATRIPTAN HYDROCHLORIDEORALTABLET, FILM COATEDANDA091441ec5b909e-3406-4154-90aa-19b996e632a8

naratriptan 2.5 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001730562AmergeNDAGlaxosmithkline Llc1998-02-26NARATRIPTAN HYDROCHLORIDEORALTABLET, FILM COATEDNDA02076313f4a8ec-75a3-4c51-b3bc-6244f3c79e95

generic product(s)(s)

#idcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1000540279ANDARoxane Laboratories, Inc2010-07-07NARATRIPTAN HYDROCHLORIDEORALTABLETANDA090381fd1944b3-8054-4faa-a82e-d818dfdd3875
2000938523ANDATeva Pharmaceuticals Usa Inc2013-08-092015-10-31NARATRIPTAN HYDROCHLORIDEORALTABLET, FILM COATEDANDA078751db26e43c-8503-4974-bbe0-5703147eced6
3003784451ANDAMylan Pharmaceuticals Inc.2012-06-13NARATRIPTAN HYDROCHLORIDEORALTABLET, FILM COATEDANDA2024317f542b45-a579-4828-8b29-a74ef9a45c6e
4005740215ANDAPaddock Laboratories, Llc2010-07-08NARATRIPTAN HYDROCHLORIDEORALTABLET, FILM COATEDANDA091326b1524990-2757-44bb-a044-dbe92ff9caaa
5007815527ANDASandoz Inc2010-07-07NARATRIPTAN HYDROCHLORIDEORALTABLET, COATEDANDA09028839c658d3-5bc8-4f81-9837-1c4edcf1b6c2
6231550055ANDAHeritage Pharmaceuticals Inc.2011-03-15NARATRIPTAN HYDROCHLORIDEORALTABLETANDA20050241c29652-32f8-48dc-9038-0e2195aa2084
7420430131ANDAOrchidpharma Inc2012-12-12NARATRIPTAN HYDROCHLORIDEORALTABLET, FILM COATEDANDA091441ec5b909e-3406-4154-90aa-19b996e632a8
8627560437ANDASun Pharmaceutical Industries Limited2011-02-22NARATRIPTAN HYDROCHLORIDEORALTABLET, FILM COATEDANDA091552ceccf36f-d165-4c2f-bed6-07ff1f5a70bc

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA078751NARATRIPTANTEVA PHARMACEUTICALS USA2010-07-07ANDA078751_001, ANDA078751_002
2ANDA090288NARATRIPTANSANDOZ INC2010-07-07ANDA090288_001, ANDA090288_002
3ANDA090381NARATRIPTANROXANE LABORATORIES INC2010-07-07ANDA090381_001, ANDA090381_002
4ANDA091326NARATRIPTANPADDOCK LABORATORIES LLC2010-07-08ANDA091326_001, ANDA091326_002
5ANDA091373NARATRIPTANAPOTEX CORP2011-04-22ANDA091373_001, ANDA091373_002
6ANDA091441NARATRIPTANORCHID HEALTHCARE2012-04-30ANDA091441_001, ANDA091441_002
7ANDA091552NARATRIPTANSUN PHARMACEUTICAL INDUSTRIES LTD2011-02-14ANDA091552_001
8ANDA200502NARATRIPTANHERITAGE PHARMACEUTICALS INC2011-02-28ANDA200502_001, ANDA200502_002
9ANDA202431NARATRIPTANMYLAN PHARMACEUTICALS INC2012-05-31ANDA202431_001, ANDA202431_002
10NDA020763AMERGEGLAXOSMITHKLINE LLC1998-02-10NDA020763_001, NDA020763_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA078751_001RXNARATRIPTAN HYDROCHLORIDE (EQ 1MG BASE)ORALTABLETFalseAB2010-07-07NARATRIPTAN
2ANDA078751_002RXNARATRIPTAN HYDROCHLORIDE (EQ 2.5MG BASE)ORALTABLETFalseAB2010-07-07NARATRIPTAN
3ANDA090288_001RXNARATRIPTAN HYDROCHLORIDE (EQ 1MG BASE)ORALTABLETFalseAB2010-07-07NARATRIPTAN
4ANDA090288_002RXNARATRIPTAN HYDROCHLORIDE (EQ 2.5MG BASE)ORALTABLETFalseAB2010-07-07NARATRIPTAN
5ANDA090381_001RXNARATRIPTAN HYDROCHLORIDE (EQ 1MG BASE)ORALTABLETFalseAB2010-07-07NARATRIPTAN
6ANDA090381_002RXNARATRIPTAN HYDROCHLORIDE (EQ 2.5MG BASE)ORALTABLETFalseAB2010-07-07NARATRIPTAN
7ANDA091326_001RXNARATRIPTAN HYDROCHLORIDE (EQ 1MG BASE)ORALTABLETFalseAB2010-07-08NARATRIPTAN
8ANDA091326_002RXNARATRIPTAN HYDROCHLORIDE (EQ 2.5MG BASE)ORALTABLETFalseAB2010-07-08NARATRIPTAN
9ANDA091373_001RXNARATRIPTAN HYDROCHLORIDE (EQ 1MG BASE)ORALTABLETFalseAB2011-04-22NARATRIPTAN
10ANDA091373_002RXNARATRIPTAN HYDROCHLORIDE (EQ 2.5MG BASE)ORALTABLETFalseAB2011-04-22NARATRIPTAN
11ANDA091441_001RXNARATRIPTAN HYDROCHLORIDE (EQ 1MG BASE)ORALTABLETFalseAB2012-04-30NARATRIPTAN
12ANDA091441_002RXNARATRIPTAN HYDROCHLORIDE (EQ 2.5MG BASE)ORALTABLETFalseAB2012-04-30NARATRIPTAN
13ANDA091552_001RXNARATRIPTAN HYDROCHLORIDE (EQ 2.5MG BASE)ORALTABLETFalseAB2011-02-14NARATRIPTAN
14ANDA200502_001RXNARATRIPTAN HYDROCHLORIDE (EQ 1MG BASE)ORALTABLETFalseAB2011-02-28NARATRIPTAN
15ANDA200502_002RXNARATRIPTAN HYDROCHLORIDE (EQ 2.5MG BASE)ORALTABLETFalseAB2011-02-28NARATRIPTAN
16ANDA202431_001RXNARATRIPTAN HYDROCHLORIDE (EQ 1MG BASE)ORALTABLETFalseAB2012-05-31NARATRIPTAN
17ANDA202431_002RXNARATRIPTAN HYDROCHLORIDE (EQ 2.5MG BASE)ORALTABLETFalseAB2012-05-31NARATRIPTAN
18NDA020763_001RXNARATRIPTAN HYDROCHLORIDE (EQ 2.5MG BASE)ORALTABLETTrueAB1998-02-10AMERGE
19NDA020763_002RXNARATRIPTAN HYDROCHLORIDE (EQ 1MG BASE)ORALTABLETFalseAB1998-02-10AMERGE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
113f4a8ec-75a3-4c51-b3bc-6244f3c79e95 (view SPL)These highlights do not include all the information needed to use AMERGE safely and effectively. See full prescribing information for AMERGE.AMERGE (naratriptan hydrochloride) tablets, for oral useInitial U.S. Approval: 1998prescriptionHuman PrescriptionGlaxosmithkline Llc2015-08-1213001730561, 001730562
239c658d3-5bc8-4f81-9837-1c4edcf1b6c2 (view SPL)These highlights do not include all the information needed to use naratriptan tablets, USP safely and effectively. See full prescribing information for naratriptan tablets, USP.NARATRIPTAN tablets, USP, for oral useInitial U.S. Approval: 1998prescriptionHuman PrescriptionSandoz Inc2014-01-155007815526, 007815527
341c29652-32f8-48dc-9038-0e2195aa2084 (view SPL)FULL PRESCRIBING INFORMATION These highlights do not include all the information needed to use Naratriptan safely and effectively. See full prescribing information for Naratriptan. Naratriptan (Naratriptan) TABLET for ORAL use. Rx only Initial U.S. Approval: 1998prescriptionHuman PrescriptionHeritage Pharmaceuticals Inc.MANUFACTURE2013-10-258231550054, 231550055
47f542b45-a579-4828-8b29-a74ef9a45c6e (view SPL)These highlights do not include all the information needed to use naratriptan tablets safely and effectively. See full prescribing information for naratriptan tablets.NARATRIPTAN tablets USP, for oral useInitial U.S. Approval: 1998prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2014-10-156003784450, 003784451
5b1524990-2757-44bb-a044-dbe92ff9caaa (view SPL)These highlights do not include all the information needed to use Naratriptan Tablets, USP safely and effectively. See full prescribing information for Naratriptan Tablets, USP.Naratriptan (naratriptan hydrochloride) Tablets, USP for oral useInitial U.S. Approval: 1998prescriptionHuman PrescriptionPaddock Laboratories, Llc2014-06-125005740214, 005740215
6ceccf36f-d165-4c2f-bed6-07ff1f5a70bc (view SPL)These highlights do not include all the information needed to use naratriptan tablets safely and effectively. See full prescribing information for naratriptan tablets. NARATRIPTAN tablets, for oral useInitial U.S. Approval: 1998prescriptionHuman PrescriptionSun Pharmaceutical Industries LimitedANALYSIS, MANUFACTURE2015-05-076627560437
7db26e43c-8503-4974-bbe0-5703147eced6 (view SPL)These highlights do not include all the information needed to use naratriptan tablets USP safely and effectively. See full prescribing information for naratriptan tablets USP. NARATRIPTAN tablets USP, for oral use Initial U.S. Approval: 1998prescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2015-04-218000938522, 000938523
8ec5b909e-3406-4154-90aa-19b996e632a8 (view SPL)These highlights do not include all the information needed to use naratriptan tablets safely and effectively. See full prescribing information for naratriptan tablets. Naratriptan Tablets USP, for oral use Initial U.S. Approval: 1998prescriptionHuman PrescriptionOrchidpharma Incanalysis, label, manufacture, pack2015-03-267420430130, 420430131
9fd1944b3-8054-4faa-a82e-d818dfdd3875 (view SPL)These highlights do not include all the information needed to use Naratriptan Tablets USP safely and effectively. See full prescribing information for Naratriptan Tablets USP.Naratriptan Tablets USP, for oral useInitial U.S. Approval: 1998prescriptionHuman PrescriptionRoxane Laboratories, IncMANUFACTURE2014-05-123000540278, 000540279

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