Application Nr Approved Date Route Status External Links
ANDA203252 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Rizatriptan Benzoate Tablets Are Indicated For The Acute Treatment Of Migraine With Or Without Aura In Adults And In Pediatric Patients 6 To 17 Years Old. Information Related To Usage Of Rizatriptan Benzoate In Pediatric Patients (6 To 17 Years Old) Is Approved For Merck & Co., Inc.’s Rizatriptan Benzoate Tablets. However, Due To Merck & Co., Inc.’s Marketing Exclusivity Rights, This Drug Product Is Not Labeled With That Pediatric Patient (6 To 17 Years Old) Usage Information. Limitations Of Use Rizatriptan Benzoate Tablets Should Only Be Used Where A Clear Diagnosis Of Migraine Has Been Established. If A Patient Has No Response For The First Migraine Attack Treated With Rizatriptan Benzoate, The Diagnosis Of Migraine Should Be Reconsidered Before Rizatriptan Benzoate Tablet Is Administered To Treat Any Subsequent Attacks. Rizatriptan Benzoate Tablets Are Not Indicated For Use In The Management Of Hemiplegic Or Basilar Migraine [See Contraindications (4) ] . Rizatriptan Benzoate Tablets Are Not Indicated For The Prevention Of Migraine Attacks. Safety And Effectiveness Of Rizatriptan Benzoate Tablets Have Not Been Established For Cluster Headache. Rizatriptan Benzoate Is A Serotonin (5-Ht) 1b/1d Receptor Agonist (Triptan) Indicated For The Acute Treatment Of Migraine With Or Without Aura In Adults And In Pediatric Patients 6 To 17 Years Of Age.( 1 ) Limitations Of Use : Use Only After Clear Diagnosis Of Migraine Has Been Established ( 1 ) Not Indicated For The Prophylactic Therapy Of Migraine ( 1 ) Not Indicated For The Treatment Of Cluster Headache ( 1 )

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Rizatriptan Benzoate RIZATRIPTAN BENZOATE ZINC1011

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