Application Nr Approved Date Route Status External Links
ANDA203478 2013-07-01 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Rizatriptan Benzoate Orally Disintegrating 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 Orally Disintegrating 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 Orally Disintegrating 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 Orally Disintegrating Tablets, The Diagnosis Of Migraine Should Be Reconsidered Before Rizatriptan Benzoate Orally Disintegrating Tablets Are Administered To Treat Any Subsequent Attacks. •rizatriptan Benzoate Orally Disintegrating Tablets Are Not Indicated For Use In The Management Of Hemiplegic Or Basilar Migraine [see Contraindications (4)]. •rizatriptan Benzoate Orally Disintegrating Tablets Are Not Indicated For The Prevention Of Migraine Attacks. •safety And Effectiveness Of Rizatriptan Benzoate Orally Disintegrating 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 (7 Total)

Name Structure Kind Function Status
1. Aspartame ASPARTAME Molecular NUTRS-Nutritive Sweetener REG-Food additives for which a petition has been filed and a regulation issued.
2. Croscarmellose Sodium CROSCARMELLOSE SODIUM Unresolved
3. Glycine GLYCINE Molecular MISC-Miscellaneous , NUTR-Nutrient , STAB-Stabilizer REG-Food additives for which a petition has been filed and a regulation issued.
4. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
5. Mannitol MANNITOL Molecular NUTR-Nutrient GRAS-Generally recognized as safe.
6. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
7. Monosodium Citrate MONOSODIUM CITRATE Molecular

Active Ingredients ( 1 Total)

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

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